## Protocol Section
### Identification Module
**NCT ID:** NCT06418971

**Acronym:** CRR

**Brief Title:** The Caregiver Resource Room (CRR): Using Technology to Enhance Support for Dementia Family Caregivers

**Official Title:** The Caregiver Resource Room: Using Technology to Enhance Support for Caregivers of Alzheimer's Disease and Related Dementias

#### Organization Study ID Info
**ID:** UP-23-00768
#### Organization
**Class:** OTHER
**Full Name:** University of Southern California
#### Secondary ID Infos
**ID:** R00AG073509
**Link:** https://reporter.nih.gov/quickSearch/R00AG073509
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2026-08-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-08-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2025-03-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-27
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute on Aging (NIA)

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Southern California

#### Responsible Party

**Investigator Affiliation:** University of Southern California

**Investigator Full Name:** Francesca B Falzarano

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to develop and test CarePair, a web-based needs assessment and service referral platform for family caregivers of persons with dementia designed to alleviate stress and promote psychosocial well being.

The main aims of this study are:

* To evaluate the feasibility and acceptability of the CarePair web application.
* To explore the potential for the CarePair web-application to reduce feelings of depression and burden, and improve caregivers' feelings of self-efficacy.

Caregiver participants will be asked to log in and test the CarePair web application and complete study activities for a three-month duration. Researchers will compare the intervention group to an attention control comparator to see if application use is associated with improved psychosocial outcomes at follow-up.

**Detailed Description:** In 2023, approximately 6.7 million diagnosed cases of Alzheimer's disease and related dementias (ADRD) were reported in the United States, with 83% of the caregiving burden shouldered by unpaid family members or friends. The duration of ADRD varies between 4-20 years, during which individuals often transition into a state of complete dependency. Without family caregivers, the long-term services and support system would be unsustainable. The dearth of accessible support for ADRD caregivers constitutes a significant public health emergency. Caregivers are frequently uncertain of which services are needed, available, and how to gain access - often leaving those most vulnerable without essential support. When queried about service underuse, study respondents who participated in the K99 phase of this project highlighted an information deficit tailored to specific cultures, demographics, and dementia types. They described the excess of online information as overwhelming, often irrelevant, impractical, or unaffordable. Existing technology-based solutions targeted toward enhancing personalized caregiver support are limited. Leveraging continued innovations in technology to inform the training and testing of machine learning algorithms, which can match and update resources while accounting for individual needs, preferences (in-person, virtual), and barriers (e.g., employment, lack of respite care), holds great potential to enhance the precision of service linkage for ADRD caregivers. This R00 project aims to develop, refine, and pilot test CarePair (formerly the Caregiver Resource Room), a web-based assessment and service referral platform for dementia caregivers. CarePair will leverage innovative machine learning algorithms to holistically evaluate caregivers' evolving needs, their barriers, and preferences to generate personalized service referrals relevant to their areas of identified need. Thus, the specific aims of the R00 are to 1) Use mixed-method and focus group data from the K99 phase to inform the iterative development of the CarePair, which includes a digital self-assessment tool employing machine learning to identify needs, categorize them, and generate targeted service recommendations; 2) Evaluate front- and back-end usability (e.g., via task analysis, heuristic evaluation) of the tool's content, design, features, functionality, and accuracy of service output. Feedback will inform modifications and iterative refinement of the CarePair Version 2.0; 3) Conduct a pilot randomized controlled trial to assess the feasibility, acceptability, and preliminary efficacy of CarePair in enhancing service awareness, addressing unmet needs, and improving mental health. The proposed research aligns with the NIA's strategic initiative to foster research scientists in aging and to develop promising interventions to better engage and support the well-being of ADRD family caregivers.

### Conditions Module

**Conditions:**

- Caregiver Burden

- Caregiver Burnout

- Dementia

**Keywords:**

- Dementia family caregivers

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants randomized to the control arm will receive an American Association of Retired Persons (AARP) caregiver handbook and will receive biweekly check-in calls asking about their caregiving situation, service use, and strategies they are using to address needs.

**Label:** Control Arm

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** After completing baseline interviews, caregivers will be introduced to and trained in the use of the CarePair through video tutorials and virtual training sessions via video-conferencing software. They will have access to an email, text, and telephone contact should they experience technical difficulties. They will be instructed to login to CarePair twice per month and complete short questionnaires assessing their use of services and satisfaction with services (if used). If they have not used services, they will be asked to indicate any perceived barriers with use. At the RCT's conclusion, participants will complete a follow-up survey to obtain quantitative and qualitative feedback about their experience. Outcomes will include pilot data on satisfaction with output of service recommendations, interaction and usability of CarePair (primary outcomes), and caregiver self-efficacy, depression and caregiver burden (secondary outcomes).

**Intervention Names:**

- Behavioral: CarePair

**Label:** CarePair Intervention Arm

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- CarePair Intervention Arm

**Description:** This study will pilot test the feasibility and acceptability of a digital self-assessment and referral tool using machine learning models to enhance service use and address unmet needs in ADRD caregivers.

**Name:** CarePair

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** The platform's built-in analytics will measure engagement via number of application logins per participant to assess participant engagement as an assessment of feasibility.

**Measure:** Participant Engagement, as Measured By Number of Application Logins Per Participant

**Time Frame:** 3 Month Follow-Up

**Description:** Five items will be administered to measure satisfaction with the intervention and web application across the following domains: 1) Overall Satisfaction; 2) Ease of Use; 3) Content Quality; 4) Design and Aesthetics; 5) Purpose Fulfillment. Responses are reported on a Likert scale ranging from 1 (not at all satisfied) to 5 (very satisfied). Total scores range from 5-25, with higher scores reflecting greater levels of participant satisfaction. Satisfaction will be evaluated based on a) the percentage of participants who report being "satisfied" or "very satisfied" with the intervention and web application, as well as b) open-ended feedback regarding the components of the application and intervention perceived to be of the most value/benefit; and c) likelihood and/or willingness to use the application in the future.

**Measure:** Rates of Participant Satisfaction with Intervention and Web Application, as Measured by Post-Intervention Feedback

**Time Frame:** 3 Month Follow-Up

**Description:** Usability and accessibility of the web application design will be measured using the validated System Usability Scale (SUS). Total scores for the SUS range from 0-100, with higher scores indicative of greater usability. A threshold score of 68 is used to indicate adequate usability.

**Measure:** Web Application Usability, as measured using the validated System Usability Scale (SUS).

**Time Frame:** 3 Month Follow-Up

#### Secondary Outcomes

**Description:** Caregiving Self-Efficacy will be measured using the Revised Scale for Caregiving Self-Efficacy. Total scores range from 0-100, with higher scores indicative of greater feelings of perceived self-efficacy.

**Measure:** Change from Baseline Caregiving Self-Efficacy scores on the 15-item Revised Scale for Caregiving Self-Efficacy at 4 Weeks.

**Time Frame:** Baseline; 3-Month Follow-Up

**Description:** The Zarit Burden Inventory (ZBI-12) will be used to measure family caregiver burden. Total scores range from 0-48, with higher scores indicative of greater burden.

**Measure:** Change from Baseline Caregiver Burden scores as measured by the validated 12-item Zarit Burden Inventory (ZBI-12).

**Time Frame:** Baseline; 3-Month Follow-Up

**Description:** The PHQ-9 will be used to measure family caregiver depressive symptoms. Total scores range from 0-27, with higher scores indicative of greater caregiver depressive symptoms.

**Measure:** Change from Baseline Caregiver Depressive Symptoms as measured by the validated Patient Health Questionnaire-9 (PHQ-9).

**Time Frame:** Baseline; 3-Month Follow-Up

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Primary caregiver of a community-dwelling person with dementia (PwD)
* Greater or equal to 18 years of age
* Able to use the internet and has internet access
* English-speaking
* Does not exhibit cognitive impairment (e.g., scoring below 3 on the Short Portable Mental Status Questionnaire, SPMSQ)

Exclusion Criteria:

* Not a primary caregiver to a community-dwelling person with dementia (PwD)
* Under 18-years-old,
* Does not speak English
* Evidence of cognitive impairment

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** falzaran@usc.edu

**Name:** Francesca B Falzarano, PhD

**Phone:** 6464812858

**Role:** CONTACT

**Contact 2:**

**Email:** ag69282@usc.edu

**Name:** Annabelle V Greenfield, BS

**Phone:** 6467809506

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Los Angeles

**Contacts:**

***Contact 1:***

- **Email:** ag69282@usc.edu

- **Name:** Annabelle Greenfield, BS

- **Role:** CONTACT

***Contact 2:***

- **Name:** Francesca Falzarano, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** University of Southern California

**State:** California

**Zip:** 90089

#### Overall Officials

**Official 1:**

**Affiliation:** University of Southern California

**Name:** Francesca Falzarano, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** Individuals who wish to access the data are required to: 1) Use the data for research purposes only; 2) Not identify any individual participant; 3) Secure the data using appropriate computer technology such as password-protected servers and files; and 4) Return and/or destroy data after analyses are complete.

**Description:** Data collected for the Caregiver Resource Room study will only be shared after the investigators have published the data addressing the study's specific aims. Intellectual property and data generated under this project will be administered in accordance with both University of Southern California (USC) and NIH policies, including the NIH Data Sharing Policy and Implementation Guidance. After publication of the investigator's main findings, access to databases and associated software tools generated and the code to create these tools under the project will be available for educational, research and non-profit purposes.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- ANALYTIC_CODE

**IPD Sharing:** YES

**Time Frame:** These data will be shared after the investigators have published the specific aims of this study. Requests for the code used to create the Caregiver Resource Room will be reviewed by the investigative team and shared once feasibility, acceptability, and preliminary efficacy has been examined and the findings have been published.

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000019965

- Term: Neurocognitive Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000013315

- Term: Stress, Psychological

- ID: D000001526

- Term: Behavioral Symptoms

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M6904

- Name: Dementia

- Relevance: HIGH

- As Found: Dementia

- ID: M2480

- Name: Caregiver Burden

- Relevance: HIGH

- As Found: Caregiver Burden

- ID: M3885

- Name: Alzheimer Disease

- Relevance: LOW

- As Found: Unknown

- ID: M1658

- Name: Burnout, Psychological

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M21836

- Name: Neurocognitive Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M16105

- Name: Stress, Psychological

- Relevance: LOW

- As Found: Unknown

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: T2192

- Name: Familial Alzheimer Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003704

- Term: Dementia

- ID: D000084802

- Term: Caregiver Burden

### Misc Info Module

- Version Holder: 2024-05-31
