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Design | A user-centered and iterative approach was adopted in the development of E-nergEYEze and applied during all stages of this pilot study. A usability study was conducted to evaluate and optimize usability, using qualitative methodology. Subsequently, potential effectiveness, feasibility of study methods and fidelity to the research protocol were examined in a feasibility study, using both qualitative and quantitative methodologies. | PMC10655361 |
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Intervention development | fatigue, visual impairment | LOW VISION | E-nergEYEze was developed by a design team represented by patients with visual impairment (n = 3), social workers (n = 2), psychologists (n = 3), information and communication technology (ICT) trainers (n = 2) of two large low vision service organizations in the Netherlands (i.e. Royal Dutch Visio and Bartiméus), and researchers (n = 5) of Amsterdam University Medical Centers and the University of Twente. They collaborated to develop the content of the intervention based on CBT and SM, tailored to user needs. Themes and content were inspired by the E-health interventions E-PsEYE [Content consisted of nine modules informing the participant on how to cope with fatigue, focusing on vision-specific and fatigue-related beliefs and behaviors. The first module was an introduction on understanding vision-related fatigue and setting personal goals, followed by eight thematic modules on: (1) Dealing with visual impairment and setting personal goals; (2) Formulating helpful fatigue-related beliefs; (3) Graded activity program; (4) Communication and social support; (5) Relaxation; (6) Improving sleep; (7) Work optimization; and (8) The future. The modules were programmed into the E-health platform (e-platform) ‘Minddistrict’ (As described in our protocol paper [ | PMC10655361 |
Recruitment | fatigue, visual impairment, Fatigue | LOW VISION | Participants were recruited through purposive sampling by social workers from the two low vision service organizations in the Netherlands between October 2019 and June 2020. Inclusion criteria for the usability study were: (a) having an ophthalmic visual impairment (visual acuity ≤ 6/18 and/or ≤ 30 degrees concentric visual field), (b) being ≥ 18 years and (c) understanding the Dutch language. For the feasibility study, participants had to meet the additional inclusion criteria of: (d) experiencing severe fatigue (Checklist Individual Strength – subscale Fatigue Severity: CIS-FS ≥ 35 points [
Overview participant flow feasibility study | PMC10655361 |
Procedure usability study | visual impairment | Usability was evaluated by five participants with visual impairment (Table | PMC10655361 |
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Ethics | The pilot study was approved by the Medical Ethics Committee of Amsterdam University Medical Centers, location VU Medical Centre in Amsterdam. All participants gave written informed consent prior to participation and where enrolled by the executive researcher. Taking into account the vulnerabilities and capacities of the target population, the information letter contained a larger font and people could contact the research team via phone or email with questions. | PMC10655361 |
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Outcome measure | fatigue, Fatigue | The primary outcome was fatigue severity measured with the CIS-FS. Fatigue severity is a subscale of 8 items, ranging from 8 to 57 points with ≥ 35 points indicating severe fatigue and is considered a valid and reliable tool [ | PMC10655361 |
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Qualitative analysis usability study | Data from the usability study were qualitatively analyzed using an inductive approach. Relevant information of the recorded files were transcribed, after which data was organized to show and interpret patterns for recurrent themes by the executive researcher [ | PMC10655361 |
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Statistical analysis feasibility study | SECONDARY | Data from the feasibility study were converted from Castor to the statistical software package SPSS for Windows version 26 (SPSS IBM, New York, USA). Quantitative data were analyzed using descriptive statistics and qualitative data were analyzed by the executive researcher using a thematic approach. In addition, user login history data from the e-platform was extracted and analyzed. As a result of the small sample size, quantitative data from primary and secondary outcomes pre-post intervention were analyzed with the Wilcoxon signed-rank test. Multiple imputation (MI) chained equations were applied for missing data post intervention with 20 iterations under the assumption that data were missing at random [ | PMC10655361 |
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Results | PMC10655361 |
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Usability study | Most participants (4/5) used assistive technology (e.g. screen reader and/or screen magnifier). Overall, participants would recommend the intervention to others (4/5) and were personally interested in following the intervention (3/5). Thematic analysis of the think aloud method and semi-structured interviews resulted in three main themes. | PMC10655361 |
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Digital challenges | Participants reported a lack of clarity on how to use the e-platform and follow the modules: the meaning of e-platform buttons were unclear (4/5), entering an answer by typing was difficult (4/5), it was difficult to activate the e-platform account at the start (3/5), it was unclear how to navigate through the e-platform (3/5) and the red error message that occurred when an assignment text area was not completed was unclear (1/5). More specifically, it was unclear where to start the training, on which page the participant was on, how to move to the next page, how many pages there were in total per module, how to share answers with the social worker and where to find the diary. Participants also experienced technical bugs, for example the cursor focus was not automatically situated at the top of a new page (3/5), the screen reader skipped unlabeled text (1/5) and diaries could not be opened with the screen reader activated (1/5). | PMC10655361 |
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Lay-out | Participants noted several inconveniencies and obscurities regarding the lay-out. Most importantly, it was difficult to obtain an overview of the overall text (4/5), big pictures had no added value (4/5), text that was put in colored text areas gave insufficient contrast (3/5), read aloud audio had a small play button (3/5), contrast of the entire screen could not be flipped into black-white (2/5), too much information on one pages (2/5), text size was not adjustable (1/5) and fold-out text areas were confusing (1/5). | PMC10655361 |
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Content | Participants gave feedback regarding the module content: it was unclear that read aloud audio and written text contained the same information (4/5) and that there were assignments at the bottom of a page (4/5), it was confusing that there were multiple read aloud audio’s on one page (3/5), it was difficult to follow the instructions in the introduction module on how to use the e-platform (2/5), it was exhausting to read written text (2/5), titles were unclear (2/5), there were too many different things at one page (1/5) and formulating personal goals in the introduction module was difficult (1/5). Strengths mentioned were the presence of read aloud audio with a pleasant voice and pace (4/5), a catching video at the start of every module (3/5), the presence of stories from fellow visually impaired people (3/5), the structure of the intervention (1/5), and the possibility to re-read assignments (1/5). | PMC10655361 |
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Improvements | meaning)-, training:- | Based on these results, we made user-specific improvements to E-nergEYEze, presented in Table
Results qualitative analysis usability study1. Mandatory computer training:- Assistance with registration in the e-platform- Instruction on e-platform features (location buttons and their meaning)- Instruction on how to navigate through the intervention (with assistive technology) and how modules are constructed- Instruction on how to dictate answers to assignments1. All text sentences were optically shortened to create a better overview2. Pictures were removed3. Colored text areas were removed4. Fold-out text areas were removed5. Two versions of the intervention were created:- Visual: written text and read aloud audio- Non-visual: only read aloud audio (no written text)1. Information and assignments on separate pages2. One read aloud audio at the top of every page3. Descriptive explanation of the content of each page*4. Setting personal goals with the social worker during the face-to-face session*total amount of pages, page number, audio time, introductory text, number of assignments, end of page, topic of the next page, how to proceed | PMC10655361 |
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Feasibility study | The feasibility study was conducted during the COVID-19 pandemic, resulting in digital face-to-face sessions between participants and social workers at the start of the intervention. All participants opted for the visual version of the intervention. One participant initially preferred the non-visual version, but switched after one week to be able to re-read information. Three participants dropped out at the beginning of the study (Fig. | PMC10655361 |
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Process evaluation participants – MHT questionnaire | Participants received sufficient information about the intervention (7/7) and on the expected outcome of the intervention (6/7). All participants experienced sufficient expertise, trust and respect from the social workers. They felt the content and guidance of E-nergEYEze was the right approach for their problems or complaints with sufficient progress throughout the intervention (7/7). For example, the intervention gave more control over their problems (6/7), they were more able to do things that were important to them (6/7) and were more able to deal with people and situations as an effect of treatment/guidance where they previously experienced problems with (5/7). The effort to correctly follow the intervention was rated with a median score of 8 (range 2–9). One participant rated her effort very low and reflected that her expectation of the module content was less psychological and more practical information. Overall, E-nergEYEze (treatment and/or guidance) received a median score of 8 (range 7–10) and was unanimously recommended to others. Three themes emerged from the open-ended questions: ‘What do you think needs to be improved to increase this rating?’ and ‘Do you have any further comments about the treatment or guidance?’. As a complement, participant experiences of the modules, assignments and overall intervention of the feasibility study are illustrated in Box | PMC10655361 |
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Accessibility | POSITIVE | The participants mentioned difficulties scrolling up and down through a page (2/7), navigating (1/7), with the unchangeable contrast (1/7) and the voice-over not being accessible enough when using the application on a mobile phone (1/7). Positive comments were the optically short sentences (1/7), the presence of videos and read aloud audio (2/7) and the convenient use of the application (2/7). | PMC10655361 |
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Content | Participants reported that the expectation of the module content should be discussed in advance (3/7), as well as the type of assignments (1/7) and estimated time investment (3/7). One participant had hoped for more concrete, practical tools, instead of a main focus on mindset. On the other hand, participants mentioned that the module content was described as clear, easy to grasp and useful. The intervention provided guidance, changed thinking skills and behavior patterns, created more self-awareness and raised awareness of having a positive mindset and energy. Filling in the diary was often forgotten, for which participants would like to receive a daily reminder (3/7). | PMC10655361 |
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Guidance | Participants were positive about the overall guidance (7/7). The social workers were pleasant during contact moments, took time to answer questions and provided feedback with sufficient depth. One of the participants preferred more intense contact with regard to the module content.
Participant experiences feasibility study
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E-platform user login history | The seven participants who followed E-nergEYEze spent a median of 11.5 weeks (range 6–15) on completing four modules. One participant exceeded the time period of three months and explained that she wanted to do really well in the module on work participation that took a little longer. The number of times logged into the e-platform was median 16 (range 9–32), of which median 11 times via the web browser (range 3–18) and median 9 times via the app (range 0–30). Five participants used both platform services and two participants only used the web browser. The face-to-face sessions took a median time of 90 minutes (range 45–120) and the number of contact moments between participant and social worker was median 6 times (range 3–11), of which 85% by message contact and 15% by telephone. The social worker spent median 120 minutes (range 65–210) guiding a participant in the e-platform. | PMC10655361 |
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Therapist process evaluation | All social workers (5/5) were satisfied with the face-to-face sessions and according to them most participants (4/7) gave sufficiently detailed answers to the assignments. Three participants gave answers that varied in comprehensiveness or were insufficient. The digital aspect of providing written feedback went well for most social workers (3/5), while some found it a positive challenge (2/5). Illustrative examples are: | PMC10655361 |
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Discussion | fatigue, visual impairment | The main focus of this pilot study was to evaluate and optimize E-nergEYEze, an E-health intervention to reduce fatigue in adults with visual impairment. The usability study resulted in adjustments based on participants’ feedback on the content and lay-out of E-nergEYEze. Digital challenges for people with visual impairment were identified and largely remedied. The feasibility study showed a positive trend in reducing fatigue severity, impact of fatigue and cognitive behavioral therapy skills. Participants’ experience was overall positive and E-nergEYEze was rated with a median score of 8 (range 7–10).We want to emphasize on the importance of conducting a pilot study of an E-health intervention before further testing or implementation. E-health is on the rise, but conducting pilot studies for successful implementation lags behind [The usability study provided detailed data where researcher judgement was necessary to determine reflective themes [The feasibility study has been conducted in a pragmatic design to reflect real-world settings and enhance external validity and generalizability [Evidence to support the use of E-health for people with visual impairment is limited [ | PMC10655361 |
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Acknowledgements | DER | We would like to thank our intervention design team members: Nelleke Schoenmakers, Marjolein van Keulen, Corine Blonk, Margreet de Vries, Sylvia van der Sluis, Petra Colen, Joke de Jager, Erna Luttik, Mark van Wijnhoven, Evert Veldman, Kirsten Veldhoen, Mirjam te Brake, Wim Grooten and Ger Klein. | PMC10655361 |
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Authors’ contributions | MH | RvN and HvdA conceived the study and its design. GvR, HK, CB and CH advised in the development of the design. LvdH contributed to the acquisition of data and MH contributed to the statistical analysis of data. MV collected the data, performed the analyses and drafted the manuscript, which was revised by the other authors. All authors read and approved the final manuscript. | PMC10655361 |
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Funding | This study was externally funded and supported by the Dutch Organization for Health Research and Development (“ZonMw program Inzicht”, grant No 60-00635-98-219).The sponsor has no role in the design and conduct of the study or in the writing of the manuscript and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results.
Trial sponsor: Amsterdam University Medical Centers.Contact Name: R.M.A. van Nispen.Address: PO Box 7057, 1007 MB Amsterdam.Telephone: +31(0)20-4444795.Email: [email protected]. | PMC10655361 |
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Data availability | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC10655361 |
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Declarations | PMC10655361 |
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Ethics approval and consent to participate | injury or death | This study protocol has been reviewed and approved by the Medical Ethical Committee of the VU University Medical Centre Amsterdam, the Netherlands (reference no. 2019/027, NL67802.029.18). The trial will be conducted according to the principles of the Declaration of Helsinki (seventh revision 2013), the Medical Research Involving Human Subjects Act (WMO) and the EU General Data Protection Regulation (GDPR). All participants signed an informed consent form to participate in the pilot study. The sponsor’s insurance policy provides coverage for damage to research subjects through injury or death caused by participation in the study. The study has been registered in the International Clinical Trial Registry Platform: NL7764. | PMC10655361 |
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Consent for publication | Not applicable. | PMC10655361 |
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Competing interests | The authors declare no competing interests. | PMC10655361 |
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Abbreviations | VIRUS DISEASE | Cognitive Behavioral TherapySelf-ManagementInformation and Communication TechnologyE-health platformChecklist Individual Strength – subscale Fatigue SeverityCorona Virus Disease 2019 caused by SARS-CoV-2Baseline assessmentCompetencies of Cognitive Therapy Scale – Self ReportPunctate Inner ChoroidopathyRetinis Pigmentosa | PMC10655361 |
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References | PMC10655361 |
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Purpose | To compare Aevidum’s school mental health curriculum vs the curriculum plus Aevidum clubs in a mixed-methods study including pre/post surveys, a randomized clinical trial, and qualitative interviews. | PMC10748452 |
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Design | Concurrent mixed-methods: Aim 1) pre-post surveys evaluated curriculum only vs curriculum plus club schools separately regarding changes in knowledge, help-seeking, and school culture; Aim 2) randomized clinical trial compared curriculum only to curriculum plus club schools; Aim 3) qualitative school staff interviews enhanced understanding of school culture changes. | PMC10748452 |
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Setting | Curriculum delivered to 9th graders at ten Pennsylvania high schools; 5 schools randomized to start clubs. | PMC10748452 |
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Subjects | Students (surveys), staff (interviews). | PMC10748452 |
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Intervention | Aevidum curriculum plus/minus club. | PMC10748452 |
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Measures | REGRESSION | Aim 1, mixed effects linear and logistic regression models for longitudinal data were used to analyze survey items at each time point. Aim 2, the same regression models were used, except models included a fixed-effect for group and group by time interaction effect. Aim 3, interviews were transcribed; a codebook was developed followed by thematic analysis. | PMC10748452 |
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Results | depression | Pre-survey 2557 respondents; 49% female, 86% non-Hispanic white. Post-survey 737 (29% response rate). Aim 1, pre-post (Likert responses, larger numbers favorable) demonstrated increased student knowledge to identify depression (4.26 [4.19-4.33] to 4.59 [4.47-4.71], | PMC10748452 |
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Conclusions | Aevidum’s curriculum improved mental health knowledge and help-seeking; adding the club did not significantly change responses. Staff identified positive school culture impacts. Limitations include the lower post-survey response. | PMC10748452 |
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Purpose | depressive, Depression | Less than half of United States adolescents experiencing a major depressive episode received treatment in 2020.The University of Michigan’s (UM) Peer-2-Peer (P2P) Depression Awareness Program was 1 such school-based initiative that aimed to decrease mental illness and promote well-being.Similar to P2P, Aevidum, meaning “I’ve got your back,” is a student-led mental health initiative started in 2010 following a peer suicide in Lancaster, Pennsylvania (PA).The study purpose was to understand the effect of the Aevidum curriculum and club on mental health knowledge, help-seeking intentions, and school culture. The study used a mixed-methods design including pre-post surveys, a randomized clinical trial design, and qualitative interviews involving ten Pennsylvania public high schools. | PMC10748452 |
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Aevidum Curriculum and Clubs | The Aevidum Mental Health & Suicide Prevention Curriculum was developed with a team of school counselors, principals, and psychologists and consists of 5 lessons delivered over 3 hours.The Aevidum club can be implemented independently of the curriculum. The intent is to foster cultures of caring, kindness, and advocacy.Ten participants allow enough trained students to launch something significant, and schools can send student leaders from different grade levels and social groups. Yet, participation is limited to ten as training often includes multiple schools.The Talk format has been endorsed by national experts (Substance Abuse & Mental Health Service Organization), and was featured on the top National Prevention Weeks campaigns. | PMC10748452 |
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Methods | PMC10748452 |
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Design & Sample | This study took place over the August 2021–June 2022 school year and focused on evaluating Aevidum curriculum and club effectiveness to improve adolescent mental health knowledge, help-seeking intentions, and school culture. Overview of the components of the mixed-methods study.CONSORT flow diagram. | PMC10748452 |
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Measures | Depression | Pre-post surveys, used with permission, were those used to evaluate P2P, the UM Depression Center P2P Depression Awareness Assessment. | PMC10748452 |
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Qualitative Component | MAY | Survey responses from curriculum only schools were compared to curriculum plus club schools to understand the added benefit of the club on school culture. However, as school culture shifts may be subtle, the student survey data was supplemented with school staff interviews to better understand school culture outcomes from Aevidum. Semi-structured interviews were conducted with up to 5 staff from each school (March 31, 2022 to May 16, 2022). Participants received a $25 gift card. A qualitative interview guide was developed, interviews were conducted via web-based meeting platform (Zoom), audio-recorded, and transcribed for analysis purposes. Transcripts were reviewed and uploaded into NVivo, a qualitative software program, for coding and analysis. | PMC10748452 |
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Analysis | PMC10748452 |
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Pre- and Post-Surveys | help-seeking behavior | REGRESSION, SECONDARY | In primary statistical analysis (Aim 1), curriculum only and curriculum plus club schools were analyzed separately, using the same methods. Mixed effects linear and logistic regression models appropriate for longitudinal (repeated measures) data were used to analyze all survey items collected at each time point. The models contained a fixed effect for time (pre vs post) and random effects for school and student. The parameter for time was the primary parameter of interest in the model, as it indicates the change over time with intervention implementation. Parameter estimates and standard errors from the models are reported along with corresponding 95% confidence intervals and In secondary statistical analysis (Aim 2), curriculum only were compared directly to curriculum plus club schools regarding changes in knowledge, help-seeking behavior, and school culture. The same mixed effects regression models were used for each survey item, except the model also included a fixed-effect for group (curriculum only vs curriculum plus club) and a group by time interaction effect. All analyses were performed using SAS statistical software version 9.4 (SAS Institute, Cary, NC). | PMC10748452 |
School Staff Semi-Structured Interviews | In Aim 3, the intent was to evaluate school culture change outcomes (eg, stigma) as a result of Aevidum. An inductive, qualitative codebook was developed by the study team after reviewing all transcripts and coming to consensus on common codes and sub-codes. Two independent coders (HC & ML) coded 20% of the data and met to determine the kappa. Substantial agreement was obtained between the 2 coders with a final kappa of .78. One coder (ML) coded the remaining data for subsequent thematic analysis. | PMC10748452 |
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Results | PMC10748452 |
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Curriculum Only vs Curriculum Plus Club (Aim 2) | depression | Comparison of responses from curriculum only to curriculum plus club schools yielded essentially no differences in pre-post test responses between groups as relates to knowledge, except those in the curriculum only arm had significantly greater odds of recognizing that feeling tired or less energetic could be a symptom of depression (OR [95% CI] for curriculum 1.88 [1.12-3.15] vs curriculum plus club schools .82 [.50-1.36], | PMC10748452 |
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Discussion | help-seeking behavior, depression | This mixed-methods evaluation of Aevidum’s mental health curriculum and club was undertaken to evaluate benefits for knowledge, help-seeking, and school culture. Ninth graders who received the curriculum and other students in the school demonstrated both improved mental health knowledge and help-seeking intentions (Aim 1).Addition of the club did not greatly impact knowledge or help-seeking. Students at curriculum plus club schools reported decreased embarrassment if seen going to the counselor’s office, but overall support for a new peer with depression was poor (Aim 2). Yet, school staff qualitative data suggests visible improvements in school culture not well-captured on the student survey (Aim 3). The findings support mental health education in schools, confirm the value of the Aevidum curriculum to improve high school student knowledge and help-seeking behavior, and point to benefits from a school staff perspective in a positive school culture shift. | PMC10748452 |
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Comparison to Prior Research | depression, Depression | Findings are similar to those from to P2P.Similar results are reported from other school-based depression curricula. The Adolescent Depression Awareness Program (ADAP) was a three-hour curriculum delivered to 710 high school students from 6 Oklahoma schools. ADAP demonstrated improved knowledge and help-seeking, but only among those exposed directly to the programming.The challenge in assessing stigma is that it relates to school culture, which may be difficult to capture in a survey. This was the rationale for inclusion of a qualitative component in this evaluation. School culture is defined as the values, attitudes, and behaviors that characterize a school.Study strengths include post-pandemic timing with a large, diverse student sample. Limitations include a lower than expected post-survey response rate due in part to difficulties with school e-mail servers. Although the Aevidum curriculum showed significant improvements in adolescent mental health knowledge and help-seeking, its impact on long-term clinical outcomes was not assessed. Schools had previously worked with the team or expressed interest in Aevidum, so results may not generalize to other educational settings without assessment of contextual, socioeconomic, and cultural differences. Also, students who participated may not represent the general adolescent population. | PMC10748452 |
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Implications and Next Steps | depression | This study contributes to the growing body of literature on school-based depression education and peer support programming. Future investigations should consider the long-term impact of the curriculum, especially sustained changes in knowledge and help-seeking with annual exposure (Aim 1). Response rates may be improved by including the assessment in the classroom at the end of curriculum delivery. This may also improve the ability to capture a broader spectrum of student opinions.Aevidum club did not demonstrate significantly greater impact vs the curriculum alone in the short-term, but this may change long-term as clubs become more established and grow their membership (Aim 2). Finally, while staff noted positive changes, barriers to implementation were also identified. Implementation of evidence-based mental health practices in the school setting is an emerging area of research that could support sustaining Aevidum programming in the school setting (Aim 3). | PMC10748452 |
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SO WHAT? | PMC10748452 |
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What is already known on this topic? | depression | Research on school-based depression education and peer support programs demonstrates improved knowledge and help-seeking. Impact on school culture and reducing stigma is mixed. | PMC10748452 |
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What does this article add? | The Aevidum curriculum and club are in widespread use, but lack formal evaluation of impacts on knowledge, help-seeking, and culture change. This evaluation considered Aevidum curriculum and club components, and added school staff perspective to better understand school culture outcomes. | PMC10748452 |
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Ethical Statement | PMC10748452 |
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Ethical Approval | The Penn State College of Medicine Institutional Review Board determined the STUDY00017706 to meet the criteria for exempt research. | PMC10748452 |
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ORCID iD | Deepa L Sekhar | PMC10748452 |
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References | PMC10748452 |
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Background | High-grade glioma, HGG, debilitating disease | HIGH-GRADE GLIOMA | High-grade glioma (HGG) is a rapidly progressing and debilitating disease. Family carers take on multiple responsibilities and experience high levels of distress. We aimed to deliver a nurse-led intervention (Care-IS) to carers to improve their preparedness to care and reduce distress. | PMC9992082 |
Methods | HGG, depression, anxiety | We conducted a randomised controlled trial (ACTRN:12612001147875). Carers of HGG patients were recruited during patients’ combined chemoradiation treatment. The complex intervention comprised four components: (1) initial telephone assessment of carer unmet needs; (2) tailored hard-copy resource folder; (3) home visit; and, (4) monthly telephone support for up to 12 months. Primary outcomes included preparedness for caregiving and distress at 2, 4, 6 and 12 months. Intervention effects were estimated using linear mixed models which included a time by group interaction. Secondary outcomes included anxiety, depression, quality of life, carer competence and strain. | PMC9992082 |
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Results | SECONDARY | We randomised 188 carers (n = 98 intervention, n = 90 control). The intervention group reported significantly higher preparedness for caregiving at 4 months (model β = 2.85, 95% CI 0.76–4.93) and all follow-up timepoints including 12 months (model β = 4.35, 95% CI 2.08–6.62), compared to the control group. However, there was no difference between groups in carer distress or any secondary outcomes. | PMC9992082 |
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Conclusions | HGG | This intervention was effective in improving carer preparedness. However, carer distress was not reduced, potentially due to the debilitating/progressive nature of HGG and ongoing caring responsibilities. Future research must explore whether carer interventions can improve carer adjustment, self-efficacy and coping and how we support carers after bereavement. Additionally, research is needed to determine how to implement carer support into practice. | PMC9992082 |
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Supplementary Information | The online version contains supplementary material available at 10.1007/s11060-023-04239-0. | PMC9992082 |
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Keywords | PMC9992082 |
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Introduction | brain cancer, anxiety, IDH, cancer, HGG, depression, oligodendrogliomas, ill, neurological deficits, glioblastoma, cognitive decline, astrocytomas, Brain cancer | BRAIN CANCER, CANCER, HIGH-GRADE GLIOMA, DISEASE, MUTANT, ANAPLASTIC ASTROCYTOMAS, OLIGODENDROGLIOMAS, SECONDARY, GLIOBLASTOMA, ASTROCYTOMAS | Brain cancer in Australia is the sixth leading cause of cancer burden with a 22% five-year relative survival rate [High-grade glioma (HGG) includes grade III anaplastic astrocytomas, oligodendrogliomas and glioblastoma (grade IV). Patients diagnosed with astrocytomas and oligodendrogliomas, IDH mutant, grade 3, may live greater than 5 years [Despite different prognoses, all HGG diagnoses are debilitating. Adults diagnosed with HGG experience functional and neurological deficits, cognitive decline, and behavioural and personality changes [Due to the progressive nature of HGG, carers rapidly transition into a carer role soon after diagnosis to manage the patients’ cognitive, personality, and functional changes and help them maintain their independent activities of daily living [Three systematic reviews have been conducted to explore supportive interventions available for “family members of seriously ill patients in hospital” [Few randomised controlled trials (RCTs) or smaller single-arm studies have been conducted to improve support provided to carers of patients with brain cancer [Leveraging this work, our Care-IS RCT aimed to deliver a nurse-led intervention to carers of patients with HGG to improve their preparedness to care and reduce distress. We hypothesised carers who receive the intervention will feel more prepared for caring and experience less psychological distress as the patient’s disease progresses. We also proposed that improving carer preparedness and reducing their distress would improve patient outcomes including patient hospital admissions and length of stay. Secondary outcomes included anxiety, depression, quality of life, carer competence, and strain. We also collected data on carer unmet needs and healthcare resource utilization and costs which will be reported elsewhere. Here we report the primary endpoints: carer preparedness and carer distress and the following secondary outcomes: anxiety, depression, quality of life, carer competence and strain. | PMC9992082 |
Methods | RECRUITMENT | A multistate Phase III RCT was conducted with eight Australian sites, three in Perth, WA and five in Sydney, NSW. CONSORT guidelines guided recruitment, monitoring of response rates, participant withdrawal and reporting.Ethics approval was gained from participating sites (NSW: HREC 16/105; SJOG: 671; SCGH: 2013-172; Curtin University: HR 17/2013). Trial registration number: Australian and New Zealand Clinical Trials Registration (ACTRN) 12612001147875. We have previously published the protocol for the RCT [ | PMC9992082 |
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Participants | HGG | Carers of HGG patients were recruited during patients’ combined chemoradiation treatment. Eligibility criteria included: being a carer of a patient with HGG currently undergoing active treatment (chemotherapy, radiation therapy or combined chemoradiation); within 2 months of initial diagnosis; age 18 years and above; and, sufficient understanding of verbal and written English. | PMC9992082 |
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Recruitment | cancer, HGG | CANCER | Screening for eligibility was carried out by the medical oncologists, radiation oncologist, neuro- surgeons, or neuro-oncology cancer nurse coordinator, at the start of treatment for HGG. As the carer was often present for the patients’ medical appointments, clinicians discussed the trial with both the patients and their carers and referred interested carers to the study team. After potential participants were identified the research assistants invited the carer and patients to participate and provided information about the trial. | PMC9992082 |
Randomisation | ONCOLOGY | Participants were randomised when they had completed the informed consent and baseline questionnaire. Participants were stratified by participating site and the patient’s Eastern Cooperative Oncology Group (ECOG) score (0–1 or ≥ 2) to ensure an even distribution between arms was achieved.Block randomisation to treatment arm within each stratification was carried out using a computer-generated randomised table. Allocation to the treatment arms was centralised with the principal investigator at Curtin University allocating participants to trial arms after informed consent and baseline data collection. This method ensured the nurses/research assistants who had initial contact with the patients/carers and responsible for data collection were not involved in allocating participants to trial arms. Individual participants were informed of their allocated treatment arm; blinding was not possible due to the nature of the intervention. | PMC9992082 |
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Intervention | ’ disease | The Care-IS intervention was developed by our multidisciplinary team (including a variety of stakeholders and consumer representatives) using the UK Medical Research Council Framework for developing and evaluating complex interventions [The Care-IS complex intervention comprised four components: (1) initial telephone assessment of carer unmet needs; (2) tailoring of a personalised resource folder; (3) home visit; (4) ongoing monthly telephone support for up to 12 months. All components of the intervention were documented and standardised in an evidence-based study manual which also contained resources for the intervention nurses to use (e.g., risk of falling; managing in an emergency). The following sections were included in the resource folder: Dealing with the diagnosis; caring for yourself; practical matters; communicating with friends or relatives; communicating with health providers; dealing with treatment, understanding physical symptoms and side effects; understanding mental and behavioural changes; lifestyle choices and complementary therapies; fertility and sexuality; and end of treatment. Carers received different parts of each section depending on the patients’ disease progression and the nurses’ assessment of the carers’ unmet needs.During the telephone assessments the intervention nurses used the Palliative Care Needs Assessment Tool (PC-NAT) [ | PMC9992082 |
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Usual care | The control arm received ‘ | PMC9992082 |
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Measures | depression, Depression, Anxiety, anxiety | Primary outcomes included: carer preparedness measured using the Preparedness for Caregiving Scale [Secondary outcomes included carer anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS) [ | PMC9992082 |
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Sample size and power calculations | The sample size was calculated based on two co-primary end points: carer preparedness and carer distress at 4 months after randomisation. Using a 5% significance level, two-tailed testing of differences between two independent groups (usual care and intervention), a sample of 64 patients per group (128 total), has 80% power to detect group differences of 0.5 SDs (moderate effect size; considered clinically significant) for carer preparedness [ | PMC9992082 |
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Data analysis | SECONDARY, REGRESSIONS | Descriptive statistics were reported as counts and percentages for categorical variables and means and standard deviations for continuous variables. Logistic regressions were performed to examine drop out at each time point. Caregivers who participated were dummy coded as 1 (retention) and those who dropped out were coded as 0 (drop out). Baseline characteristics were then entered as predictors of drop-out at each time-point. Results indicated unmarried, divorced or widowed caregivers were more likely to dropout at 2 months, and those who had reduced their working hours or stopped working were more likely to drop out at 4, 6 and 12 months (see Supplementary Table B). As a result these variables were adjusted for in the main analysis.Linear mixed models (PROC Mixed procedure), with an unstructured correlation matrix, were used to estimate between-group differences in the primary and secondary outcomes at each time point and to determine the predicted least-square (LS) mean values. Each model included group (intervention or control) as a fixed effect, and time as both a fixed and random effect. Each model was adjusted for marital status and change in employment status (fitted as fixed effects), and also included a time by group interaction.The effect of missing data was investigated as part of a sensitivity analysis using multiple imputation under the missing not at random (MNAR) assumption by searching for a tipping point that reverses the primary outcome conclusion [All analyses were performed using Statistical Analysis Software (SAS/STAT) (version 9.4; SAS Institute, Cary, NC). | PMC9992082 |
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Discussion | HGG | The Care-IS intervention was effective in improving carer self-reported preparedness to care at 4 months and subsequent points until 12 months when data collection ceased. This work builds on Boele et al.’s [We found, despite improvements in carer preparedness, for carers who remained in the RCT carer distress was not significantly different at follow-up time points compared to participants in the control group. Similarly, QoL was not significantly different between groups. We propose changes did not occur in the intervention group due to the debilitating and progressive nature of HGG and ongoing caring responsibilities. This finding contrasts with Thakur et al.’s [While we have demonstrated we can improve carers’ preparedness to care, reducing carers distress is challenging due to clinical context and declining trajectory of HGG patients. Coping with ongoing deterioration in health status of patients will present consistent new challenges and feelings of loss in carers, which this complex intervention was unable to mitigate in comparison to the control arm. Hudson et al.’s [Usual care for patients diagnosed with HGG and their carers varies across Australia [While our intervention involved provision of information, support, and referrals for carers and patients, we do not currently know whether this advice was actioned by individual carers. There is a need to map referrals made to services accessed to understand the advice carers were able to implement. There is a need to explore, perhaps using mixed methods designs, the barriers to carer implementation of advice and/or referrals to overcome these barriers to care. | PMC9992082 |
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Limitations | brain cancer, depression, anxiety | BRAIN CANCER, RECRUITMENT | Our RCT was limited by only including English speaking carers living in Australia. There was a substantial drop-out across both arms in the trial, highlighting the challenges of longitudinal research in this population. Exploration of missing data via sensitivity analyses indicated if participants in the intervention group who dropped out at the 4-month time point reported worse preparedness for caregiving by 0.80 points compared to those who dropped out of the control group, the identified difference in preparedness for caregiving between groups would be non-significant. However, we have no reason to believe those who dropped out of the intervention group would be different to those who dropped out of the control group. Another potential factor may be the usual care provided at the recruitment sites, most of which had dedicated specialist brain cancer nurses on-site within tertiary care settings. Conceivably, this care had already maximized any changes in quality of life, anxiety, depression or caregiver strain which were able to be improved through nursing support, with more intensive nursing intervention unable to achieve additional gains. | PMC9992082 |
Conclusion | HGG | DISEASE | This intervention was effective in improving carer self-reported preparedness. However, carer distress was not reduced, potentially due to the debilitating and progressive nature of HGG and their ongoing caring responsibilities as the disease progresses. Future research needs to explore the type and timing of support carers of people with HGG would find most helpful and co-design strategies to implement their preferred type of support into usual care. Understanding the longer-term patterns of distress, into the bereavement period, may provide important insights into the effectiveness of interventions such as ours. | PMC9992082 |
Acknowledgements | GILBERT | Thank you to the clinicians who recruited and referred participants; Claire Savage, Emily Hepsworth, Linda Ye, Mary Corker, Michelle McMullen, Sanju Kondola, Tim Humphries, Daphne Tsoi, Elizabeth Hovey, Dari Place, Georgia Ritchie, Joyce Bonello, Cecelia Gzell, Subotheni Thavaneswaran, Suzanne McNella, Tracey Dunlop, Kelly Conway, Iris Wong, Stella Lee, Hao-Wen Sim, Brindha Shivalingam and Samantha Bowyer. Thank you Care-IS research team members; who contributed at different stages during the study; Jade Newton, Laura Emery, Marie Gilbert, Robyn Atwood, Lisa Miller, Meera Agar, Rachael Moorin, Therese Shaw and Max Bulsara. We also thank our consumer representatives (Diana Andrew, Anne Wakeling and Kim Peppiatt) and all the patients and carers who participated in the Care-IS trial. | PMC9992082 |
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Author contributions | JP, HD, EL | GH, AN, EL, JP, PH conceptualised the project and successfully attracted funding for the study. EM, JC, GH collected the data. RC and KM provided statistical advice and conducted the initial data analysis. GH, EM, RC, HD, EL, AN prepared the manuscript. All authors reviewed the manuscript and provided critical input. | PMC9992082 |
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Funding | Brain cancer, Cancer | CANCER | Open Access funding enabled and organized by CAUL and its Member Institutions. This project was funded by a Cancer Australia Priority-driven Collaborative Cancer Research Scheme project grant (APP1105307). Data analysis was supported by funding from the Medical Research Future Fund for the Brain cancer Rehabilitation, Assessment, Intervention of survivor NeedS (BRAINS) project. Georgia Halkett is currently supported by a Cancer Council of WA Research Fellowship. | PMC9992082 |
Declarations | PMC9992082 |
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Competing interests | The authors declare no competing interests. | PMC9992082 |
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References | PMC9992082 |
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Abstract | PMC9835442 |
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Background | VIRUS, INFLUENZA | Persons experiencing homelessness face increased risk of influenza as overcrowding in congregate shelters can facilitate influenza virus spread. Data regarding on‐site influenza testing and antiviral treatment within homeless shelters remain limited. | PMC9835442 |
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Methods | cough, respiratory illness, ARI | INFLUENZA, VIRUS INFECTION, INFLUENZA | We conducted a cluster‐randomized stepped‐wedge trial of point‐of‐care molecular influenza testing coupled with antiviral treatment with baloxavir or oseltamivir in residents of 14 homeless shelters in Seattle, WA, USA. Residents ≥3 months with cough or ≥2 acute respiratory illness (ARI) symptoms and onset <7 days were eligible. In control periods, mid‐nasal swabs were tested for influenza by reverse transcription polymerase chain reaction (RT‐PCR). The intervention period included on‐site rapid molecular influenza testing and antiviral treatment for influenza‐positives if symptom onset was <48 h. The primary endpoint was monthly influenza virus infections in the control versus intervention periods. Influenza whole genome sequencing was performed to assess transmission and antiviral resistance. | PMC9835442 |
Results | ARI | VIRUS, INFLUENZA, VIRUS INFECTION, INFLUENZA | During 11/15/2019–4/30/2020 and 11/2/2020–4/30/2021, 1283 ARI encounters from 668 participants were observed. Influenza virus was detected in 51 (4%) specimens using RT‐PCR (A = 14; B = 37); 21 influenza virus infections were detected from 269 (8%) intervention‐eligible encounters by rapid molecular testing and received antiviral treatment. Thirty‐seven percent of ARI‐participant encounters reported symptom onset < 48 h. The intervention had no effect on influenza virus transmission (adjusted relative risk 1.73, 95% confidence interval [CI] 0.50–6.00). Of 23 influenza genomes, 86% of A(H1N1)pdm09 and 81% of B/Victoria sequences were closely related. | PMC9835442 |
Conclusion | INFLUENZA | Our findings suggest feasibility of influenza test‐and‐treat strategies in shelters. Additional studies would help discern an intervention effect during periods of increased influenza activity.
| PMC9835442 |
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BACKGROUND | deaths | INFLUENZA | Seasonal influenza is estimated to have caused between 9–41 million illnesses, 140,710,000 hospitalizations and 12,000–52,000 deaths annually between 2010 and 2020 in the United States.Nearly a third of PEH in the United States stay in emergency shelters or transitional housing programs.Rapid point‐of‐care influenza molecular tests have high sensitivity and specificity. | PMC9835442 |
METHODS | PMC9835442 |
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Study design overview | SECONDARY, INFLUENZA | We conducted a cluster‐randomized stepped‐wedge trial of a point‐of‐care molecular influenza testing with antiviral treatment intervention in shelters in King County, Washington (WA). The objective of the trial was to evaluate the feasibility and impact of the intervention on the number of secondary influenza cases within homeless shelters. Ethics approval was obtained from the University of Washington Human Subjects Division. The full protocol has been previously described. | PMC9835442 |
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Setting and participants | cough, respiratory illness, ARI | INFLUENZA | This study was conducted initially at nine homeless shelters in King County, WA. Participants were enrolled over a cumulative 12 months, composed of two 6‐month influenza seasons, from 11/15/19 to 4/30/20 in Year 1 and from 11/2/20 to 4/30/21 in Year 2.Study eligibility criteria included being a resident at a participating shelter; age ≥ 3 months old; and experiencing new or worsening cough alone or two or more acute respiratory illness (ARI) symptoms in the last 7 days. During the intervention period, criteria included willingness to perform a rapid influenza molecular test and take study medication if the result was positive. | PMC9835442 |
Randomization and intervention | CORONAVIRUS DISEASE 2019, INFLUENZA | We used a stepped‐wedge cluster‐randomized trial, where randomization occurred at the cluster (shelter) level. The design involved monthly random and sequential crossover of clusters from control periods to intervention periods with influenza testing at kiosks until all clusters implemented the intervention. Nine shelters were randomized to the four sequences, with rerandomization at the start of each year (Figure Stepped‐wedge cluster‐randomized trial design and shelter randomization assignments, Years 1 and 2. COVID‐19, coronavirus disease 2019; RCT, randomized controlled trial | PMC9835442 |
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Study procedures | PMC9835442 |
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Recruitment | Participants were recruited from staffed influenza‐surveillance kiosks at each shelter and screened for eligibility. Participants were recruited 6 days per week. To encourage participation, regular staffed kiosk hours were advertised with flyers and regular announcements at shelters. Telephonic translation services were available for participants who did not speak English. | PMC9835442 |
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Control period | STERILE | Eligible individuals had mid‐turbinate nasal swabs collected (self‐collected by participants from 3/6/2020 onwards) using sterile nylon flocked swabs (Copan Diagnostics) and filled surveys providing self‐reported demographic and clinical data on an electric tablet; survey variables and shelter site data have been previously described. | PMC9835442 |
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Intervention period | active malignancy | INFLUENZA A, APPENDIX, LIVER DISEASE, INFLUENZA | Trained kiosk staff conducted on‐site rapid molecular influenza testing (Abbott ID NOW, Abbott Laboratories, Lake Bluff, IL, USA), which detects and distinguishes between influenza A and B, and produces a result in 12 min, using nasal specimens collected from participants. Baloxavir (XOFLUZA, Genentech, San Francisco, CA, USA) was administered to all influenza‐positive participants aged ≥12 years. Study clinicians were available by phone to respond to questions or concerns that could not be directly addressed by the kiosk staff. For individuals who tested positive aged 3 months to 11 years, pregnant or breastfeeding, or adults with active malignancy, liver disease, or immunocompromised, a 5‐day treatment course of oseltamivir (TAMIFLU, Roche, Basel, Switzerland) was dispensed. All other individuals aged ≥12 years received a single dose of baloxavir (Appendix Participants with symptom onset < 48 h were eligible for the intervention as initiation of antiviral treatment is recommended within 48 h of influenza symptom onset for greatest clinical benefits. | PMC9835442 |
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