Preliminary evaluation of a family-focused psychoeducational programme for stroke survivors and their family caregivers

Not Applicable

Completed

• Conditions: Stroke; Circulatory System; Stroke, not specified as haemorrhage or infarction

• Registration Number: ISRCTN18158500
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36544154/ results (added 30/03/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-02-27
• Study Start: 2022-10-10
• Last Update Posted: 10 April 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Stroke survivors:
1. Being firstly diagnosed with stroke within one month, aged 18 years or above
2. Being able to understand the intervention and communicate with the researcher
3. Given informed consent to participate in this study
4. Having a main family caregiver (i.e., another member of the dyad) as the family dyad in this study

Family caregivers:
1. The main family members who are responsible to take major care of the stroke survivors
2. Aged 18 years or above
3. Able to understand the study and intervention and communicate with the researcher
4. Given informed consent to participate in this study

Exclusion Criteria

Stroke survivors:
1. Less than 6 months life expectancy, or other comorbidities in higher priority than their stroke rehabilitation
2. Having moderate or severe cognitive deficits
3. Been engaging in any other research and/or bio-psychosocial intervention
4. High independence in daily activity performance

Family caregivers :
1. History of major mental illness such as mood and psychotic disorders
2. Visual (blindness), auditory (deafness) and/or cognitive impairments
3. Engaging in other stroke care research and/or psychosocial or physical intervention

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Feasibility, measured by:<br> 1.1. Recruitment rates (calculated as the percentage of the participants being enrolled/randomised divided by those who are eligible for study participation at baseline)<br> 1.2. Attrition rates (calculated as the percentage of those participants not able to complete the study or the outcome assessment immediately post-intervention)<br> 1.3. Adherence to interventions of the participants (measured as the percentage of participants attending =60% of the intervention sessions, i.e. =2 of 3 sessions in part I and =3 of 4 calls in part II)<br> 2. Acceptability, open-ended questions, including the appropriateness of the intervention and the experiences of participating in the FDPEI, measured immediately post-intervention<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Stroke survivors' functioning, measured by Stroke Impact Scale 3.0, at pre- and post-test<br> 2. Caregiver burden, measured by Caregiver Burden Inventory, at pre- and post-test<br> 3. Caregivers' competence, measured by Caregiving Competence Scale, at pre- and post-test<br> 4. Dyads' coping, measured by Family Crisis Oriented Personal Evaluation Scale, at pre- and post-test<br> 5. Dyads' depressive symptoms, measured by Patient Health Questionnaire-9, at pre- and post-test<br> 6. Dyads' anxiety symptoms, measured by Generalised Anxiety Scale-7, at pre- and post-test<br> 7. Dyads' family functioning, measured by general functioning of McMaster Family Assessment Device, at pre- and post-test<br> 8. Dyadic relationship, measured by Mutuality Scale, at pre- and post-test<br>