A randomized trial to evaluate an education programme for patients and carers after stroke. Expanding the role of the stroke nurse: a pragmatic clinical trial. Randomised trial of a computer-generated tailored written education package for patients following stroke. Evaluation of a stroke family care worker: results of a randomised controlled trial. A randomized controlled trial of an education and counselling intervention for families after stroke. Training carers of stroke patients: randomised controlled trial. Randomized controlled trial of a comprehensive stroke education program for patients and caregivers. Evaluation of a stroke family support organiser: a randomized controlled trial. The impact of an information pack on patients with stroke and their carers: a randomized controlled trial. The impact of a nurse-led support and education programme for spouses of stroke patients: a randomized controlled trial. Multicenter randomized controlled trial of an outreach nursing support program for recently discharged stroke patients. [Interpersonal psychotherapy and pharmacotherapy for post-stroke depression. Feasibility and effectiveness]. The effects of a shared decision-making intervention in primary care of depression: a cluster-randomized controlled trial.
To evaluate the effectiveness of an education programme for patients and carers recovering from stroke.
                Randomized controlled trial.
                One hundred and seventy patients admitted to a stroke rehabilitation unit and 97 carers of these patients.
                The intervention group received a specifically designed stroke information manual and were invited to attend education meetings every two weeks with members of their multidisciplinary team. The control group received usual practice.
                Primary outcome was knowledge of stroke and stroke services. Secondary outcomes were handicap (London Handicap Scale), physical function (Barthel Index), social function (Frenchay Activities Index), mood (Hospital Anxiety and Depression Scale) and satisfaction (Pound Scale). Carer mood was measured by the General Health Questionnaire-28.
                There was no statistical evidence for a treatment effect on knowledge but there were trends that favoured the intervention. The education programme was associated with a significantly greater reduction in patient anxiety score at both three months (p =0.034) and six months (p =0.021) and consequently fewer 'cases' (Hospital Anxiety and Depression Scale anxiety subscale score > or =11). There were no other significant statistical differences between the patient or carer groups for other outcomes, although there were trends in favour of the education programme.
                An education programme delivered within a stroke unit did not result in improved knowledge about stroke and stroke services but there was a significant reduction in patient anxiety at six months post stroke onset. This paper reports a study evaluating whether expanding a specialist nursing role to provide outreach education and support to stroke patients and carers after discharge from hospital is effective in promoting recovery.
                Building therapeutic relationships with patients and carers is a key component of the nursing role in stroke rehabilitation, although this is limited by the constraints of service organization.
                A pragmatic randomized controlled trial was undertaken. Patients with a diagnosis of stroke were randomized to receive continued support from a stroke nurse (n = 87) or usual care and follow-up (n = 89) after discharge from hospital. Patients were recruited from two hospitals in the north-west of England from November 1999 to April 2001. Patient dependence (Barthel Index), general health (Nottingham Health Profile), activities of living (Frenchay Activity of Living Index), depression (Beck Depression Inventory) and carer strain (Carer Strain Index) were assessed at 3 and 12 months after stroke.
                The continued intervention of a stroke nurse after discharge was associated with improved patient perceptions of general health at 12 months (median difference 42.6, P = 0.012), and in particular reduced negative emotional reaction (P = 0.037) and perceived social isolation (P = 0.002). In addition, the intervention reduced carer strain at 3 months (P = 0.045), and reduced deterioration in physical dependence from 3 to 12 months (P = 0.049).
                The provision of continued intervention from a stroke nurse after discharge from hospital, focusing on education and support, has tangible benefits for patients and carers. The ideal method of providing stroke patients with information has not been established.
                To evaluate the effectiveness of providing stroke patients with computer-generated tailored written information.
                Randomised controlled trial with blinded assessor.
                Acute stroke unit.
                138 stroke patients.
                Patients were randomised to receive either computer-generated tailored written information about stroke or generic written information while in hospital. Three months following discharge, a blinded assessor evaluated the outcomes of knowledge about stroke, self-efficacy (Self-Efficacy to Perform Self-Management Behaviours Scale), anxiety and depression (Hospital Anxiety and Depression (HAD) Scale), perceived health status (COOP charts), satisfaction with content and presentation of the written information received (separate 10-point visual analogue scale for content and presentation), and desire for additional information.
                Complete data were obtained for 133 (96.4%) patients. Patients in the intervention group were significantly more satisfied with the content (difference on a 10-point visual analogue scale was 1, 95% confidence interval 0.4 to 1.7, P = 0.003) and presentation (difference on a 10-point visual analogue scale was 1.2, 95% confidence interval 0.6 to 1.9, P < 0.001). Significantly, fewer patients in the intervention group desired additional information about stroke at follow-up than patients in the control group (4.5% versus 32.8%; P < 0.001). Anxiety change scores improved slightly more in favour of the control group (1.4 difference on the HAD subscale, 95% confidence interval 0.2 to 2.8, P = 0.03). No significant differences between the groups were observed for any of the other outcome measures.
                Providing stroke patients with computer-generated tailored written information improved satisfaction with the information that was received and was more effective in meeting patients' informational needs than non-tailored information, but had no effect on knowledge about stroke, self-efficacy, depression, or perceived health status. To examine the effect of contact with a stroke family care worker on the physical, social, and psychological status of stroke patients and their carers.
                Randomised controlled trial with broad entry criteria and blinded outcome assessment six months after randomisation.
                A well organised stroke service in an Edinburgh teaching hospital.
                417 patients with an acute stroke in the previous 30 days randomly allocated to be contacted by a stroke family care worker (210) or to receive standard care (207). The patients represented 67% of all stroke patients assessed at the hospital during the study period.
                Patient completed Barthel index, Frenchay activities index, general health questionnaire, hospital anxiety and depression scale, social adjustment scale, mental adjustment to stroke scale, and patient satisfaction questionnaire; carer completed Frenchay activities index, general health questionnaire, hospital anxiety and depression scale, social adjustment scale, caregiving bassles scale, and carer satisfaction questionnaire.
                The groups were balanced for all important baseline variables. There were no significant differences in physical outcomes in patients or carers, though patients in the treatment group were possibly more helpless less well adjusted socially, and more depressed, whereas carers in the treatment group were possibly less hassled and anxious. However, both patients and carers in the group contacted by the stroke family care worker expressed significantly greater satisfaction with certain aspects of their care, in particular those related to communication and support.
                The introduction of a stroke family care worker improved patients' and their carers' satisfaction with services and may have had some effect on psychological and social outcomes but did not improve measures of patients' physical wellbeing. To determine whether education and counselling after stroke leads to improved family functioning and psychosocial outcomes for stroke patients and their spouses, and better functional and social outcomes for patients.
                Two-group randomized controlled trial. Data were collected on admission to and discharge from rehabilitation, and again six months later.
                Rehabilitation units at Repatriation General Hospital and Griffith Hospital, in Adelaide, South Australia.
                Sixty-two stroke patients and their spouses, 32 in the intervention group and 30 in the control group.
                Stroke information package and three visits from a social worker trained in family counselling.
                Family functioning: McMaster Family Assessment Device (FAD); functional status: Barthel Index (BI); social recovery: Adelaide Activities Profile (AAP); depression: Geriatric Depression Scale (GDS); anxiety: Hospital Anxiety and Depression Scale (HADS); mastery: Mastery Scale (MS); health status: SF-36.
                At six months the intervention group had better family functioning for both patients (mean FAD difference 0.19) and spouses (mean difference 0.09). A modest benefit in functional status for intervention patients (mean BI difference 1.3) was related to improved family functioning. Intervention patients reported better social recovery (mean AAP differences: domestic chores 5.7, household maintenance 4.6, social activities 11.5), but there were no significant effects on depression, anxiety, mastery or health status.
                An education and counselling intervention maintained family functioning, and in turn led to improved functional and social patient outcomes. This approach helps patients and their spouses to make the optimal adjustment to living with stroke. Informal care givers support disabled stroke patients at home but receive little training for the caregiving role.
                To evaluate the effectiveness of training care givers in reducing burden of stroke in patients and their care givers.
                A single, blind, randomised controlled trial.
                Stroke rehabilitation unit.
                300 stroke patients and their care givers.
                Training care givers in basic nursing and facilitation of personal care techniques.
                Cost to health and social services, caregiving burden, patients' and care givers' functional status (Barthel index, Frenchay activities index), psychological state (hospital anxiety and depression score), quality of life (EuroQol visual analogue scale) and patients' institutionalisation or mortality at one year.
                Patients were comparable for age (median 76 years; interquartile range 70-82 years), sex (53% men), and severity of stroke (median Barthel index 8; interquartile range 4-12). The costs of care over one year for patients whose care givers had received training were significantly lower (10,133 pounds sterling v 13,794 pounds sterling (18,087 dollars v 24,619 dollars; 15,204 euros v 20,697 euros); P = 0.001). Trained care givers experienced less caregiving burden (care giver burden score 32 v 41; P = 0.0001), anxiety (anxiety score 3 v 4; P = 0.0001) or depression (depression score 2 v 3; P = 0.0001) and had a higher quality of life (EuroQol score 80 v 70; P = 0.001). Patients' mortality, institutionalisation, and disability were not influenced by caregiver training. However, patients reported less anxiety (3 v 4.5; P < 0.0001) and depression (3 v 4; P < 0.0001) and better quality of life (65 v 60; P = 0.009) in the caregiver training group.
                Training care givers during patients' rehabilitation reduced costs and caregiver burden while improving psychosocial outcomes in care givers and patients at one year. We report the findings of a randomized controlled trial to determine the effectiveness of a multidisciplinary Stroke Education Program (SEP) for patients and their informal carers.
                Two hundred four patients admitted with acute stroke and their 176 informal carers were randomized to receive an invitation to the SEP or to receive conventional stroke unit care. The SEP consisted of one 1-hour small group educational session for inpatients followed by six 1-hour sessions after discharge. The primary outcome measure was patient- and carer-perceived health status (SF-36) at 6 months after stroke. Knowledge of stroke, satisfaction with services, emotional outcome, disability, and handicap and were secondary outcome measures.
                Only 51 of 108 (47%) surviving patients randomized to the SEP completed the program, as did 20 of 93 (22%) informal carers of surviving patients. Perceived health status (Short Form 36 [SF-36] health survey) scores were similar for SEP patients and controls. Informal carers in the control group scored better on the social functioning component of the SF-36 than the SEP group (P=0.04). Patients and informal carers in the SEP group scored higher on the stroke knowledge scale than controls (patients, P=0.02; carers, P=0. 01). Patients in the SEP group were more satisfied with the information that they had received about stroke (P=0.004). There were no differences in emotional or functional outcomes between groups.
                Although the SEP improved patient and informal carer knowledge about stroke and patient satisfaction with some components of stroke services, this was not associated with an improvement in their perceived health status. Indeed, the social functioning of informal carers randomized to the SEP was less than in the control group. There is inconclusive evidence of the effectiveness of the Stroke Family Support Organiser (FSO) service. We report the results from a randomized controlled trial of the service.
                Stroke patients admitted to hospital and their informal caregivers were randomly allocated to receive the FSO service (n=126) or standard care (n=124). Outcome assessments were undertaken 4 and 9 months after recruitment with the General Health Questionnaire 12, Carer Strain Index, Barthel Index, Extended Activities of Daily Living scale, and a specially designed questionnaire to determine knowledge of stroke and satisfaction with services.
                There were no significant differences between groups in patients' mood and independence in personal or instrumental activities of daily living or caregivers' mood, strain, or independence. Patients in the intervention group were significantly more knowledgeable about whom to contact for stroke information, reducing the risk of stroke, practical help, community services, and emotional support. Patients in the intervention group were also significantly more satisfied with the stroke information received. Caregivers in the intervention group were significantly more knowledgeable about whom to contact for information on stroke, reducing the risk of stroke, community services, and emotional support. Caregivers in the intervention group were also significantly more satisfied with stroke information.
                The FSO service had no significant effect on mood, independence in activities of daily living, or reduction in caregiver strain, but it did increase knowledge of stroke and satisfaction with that knowledge. The results may not be representative of all FSO services, and the sample was small relative to the heterogeneity of the participants. However, results suggest that the policies and training procedures of FSOs need to be evaluated to ensure that a cost-effective service is being provided to stroke patients and their caregivers. To assess the impact of information packs on patients with stroke and their carers, and to pilot some of the methodology for a trial of a Family Support Organiser (FSO).
                Seventy-one patients admitted to Oxford hospitals with acute stroke during February-July 1995, and 49 informal carers of these patients.
                Randomized controlled trial. Intervention group received an Information pack containing various Stroke Association publications one month after their stroke, or at discharge from hospital, whichever was sooner. Control group received nothing. Follow-up was by interview at the place of residence of the patients six months after their stroke.
                Outcome measures assessed knowledge about stroke; satisfaction with information received; patient behaviour in terms of access to community services and benefits; and health status and quality of life.
                Patients and carers in the intervention group tended to know more about stroke, but these differences were not significant once adjusted for age. Patients in the intervention group (but not carers) tended to be more satisfied with the information that they had received, but the differences were not significant. There were no differences with regard to any aspects of quality of life in patients in the intervention group, though carers in the intervention group were found to have significantly better mental health (p = 0.04).
                While the study was too small to generate firm conclusions, information leaflets may lead to improved knowledge about stroke several months after they have been distributed. This finding is worth following up with larger studies. The stroke knowledge questionnaire that was piloted in this trial seems to be able to detect differences between groups. The aim of the present study was to determine the impact of a nurse-led support and education programme for improving the spouses' perceived general quality of life, life situation, general well-being and health state.
                Stroke is a disease with great consequences for the patients and their families. The spouses often feel obligated to care for the patient, providing psychological and physical support and having to cope with the patient's physical and cognitive impairments. This might lead to increased problems, as family members struggle to adapt to their new roles and responsibilities.
                Longitudinal, randomized controlled trial. One hundred spouses were randomly assigned to intervention or control groups, 50 in each group. The intervention group participated in a support and education programme, six times during six months, led by stroke specialist nurses. Both groups were followed for 12 months.
                No significant differences were found, between intervention and control groups, over time. In the sub analyses, we found that the group attending 5-6 times had a significant decrease in negative well-being and increased quality of life over time, while the group attending fewer times had a significant decrease in positive well-being and health state, similar to the control group, which also had a significant decrease in negative and general well-being.
                A support and education programme might have a positive effect on spouses' well-being, on condition that they attend at least five times.
                To facilitate the spouses' role as informal caregivers to the stroke patients, further development of the support and education programme used in the present study is needed, including empowerment approach and implementation of coping strategies. Many stroke patients and informal carers experience a decreased quality of life after discharge home and are dissatisfied with the care received. We assessed the effectiveness of an outreach nursing care program.
                In a multicenter trial, 536 stroke patients were randomized at discharge to standard care (n=273) or standard care plus outreach care (n=263). The outreach care consisted of 3 telephone calls and 1 home visit within 5 months after discharge by 1 of 13 stroke nurses. Patients were masked for the trial objectives. Six months after discharge, they assessed the 2 primary outcomes: quality of life (Short Form 36 [SF-36]) and dissatisfaction with care. Secondary measures of outcome were disability, handicap, depression, anxiety, and use of health care services and secondary prevention drugs. Informal carers assessed strain, and social support. Analysis was by intention to treat.
                Twelve patients died before follow-up, 38 declined outcome assessment, and 486 completed the primary outcome assessments. Outreach care patients had better scores on the SF-36 domain "Role Emotional" than controls (mean difference 7.9 [95% confidence limit, 0.1 to 15.7]). No statistically significant differences were found on the other primary outcome measures. For secondary outcomes, no statistically significant differences were found, except that intervention patients used fewer rehabilitation services (relative risk, 0.66 [0.44 to 1.00]) and had lower anxiety scores (median difference 1 [0.19 to 2.79]).
                This outreach nursing stroke care was not effective in improving quality of life and dissatisfaction with care of recently discharged patients. Only few studies investigated the effectiveness of psychotherapy in post-stroke depression (PSD). The aim of this feasibility study was to compare interpersonal psychotherapy, pharmacotherapy, and their combination regarding depression and rehabilitation outcome.
                Post-stroke depression was found in 35% of 485 stroke patients examined. Seventy-four PSD patients were randomised to one of three treatment conditions. Severity of depression was measured by the Hamilton Depression Rating Scale and the Hospital Anxiety and Depression Scale. The Barthel Index and a questionnaire for health-related quality of life were used as measurements of rehabilitation outcome.
                There were no significant differences between the three groups in patient mood or rehabilitation outcome. Concerning the severity of depression, quality of life, and social support, all patients showed benefits from antidepressive treatment. In addition a correlation was found between rehabilitation outcome and depression.
                In this feasibility study all antidepressive treatments were successfully implemented in the rehabilitation of post-stroke depressed patients. Combination therapy (interpersonal psychotherapy plus medication) was as effective as one of those elements alone. Because of the small sample size however, further randomized trials are required. Patient-centred depression care approaches should better address barriers of insufficient patient information and involvement in the treatment decision process. Additional research is needed to test the effect of increased patient participation on outcomes. The aim of this study was to assess, if patient participation in decision-making via a shared decision-making intervention leads to improved treatment adherence, satisfaction, and clinical outcome without increasing consultation time.
                Cluster-randomized controlled intervention study based on physician training and patient-centered decision aid compared to usual care in primary care settings in Südbaden region of Germany. Twenty-three primary care physicians treating 405 patients with newly diagnosed depression were enrolled. Patient involvement was measured with the patient perceived involvement in care scale (PICS) and a patient participation scale (MSH-scale). Patient satisfaction was measured by the CSQ-8 questionnaire. Treatment adherence was evaluated by patient and provider self-report. Depression severity and remission outcomes were assessed with the Brief PHQ-D.
                Physician facilitation of patient participation improved significantly and to a greater extent in the intervention compared to the control group. There was no intervention effect for depression severity reduction. Doctor facilitation of patient participation, patient-rated involvement, and physician assessment of adherence improved only in the intervention group. Patient satisfaction at post-intervention was higher in the intervention group compared to the control group. The consultation time did not differ between groups.
                A shared decision-making intervention was better than usual care for improving patient participation in treatment decision-making, and patient satisfaction without increasing consultation time. Additional research is needed to model causal linkages in the decision-making process in regard to outcomes.
                The study results encourage the implementation of patient participation in primary care of depression.
There is evidence that information improves patient and carer knowledge of stroke, aspects of patient satisfaction, and reduces patient depression scores. However, the reduction in depression scores was small and may not be clinically significant. Although the best way to provide information is still unclear there is some evidence that strategies that actively involve patients and carers and include planned follow-up for clarification and reinforcement have a greater effect on patient mood.