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

Effectiveness of a family-focused dyadic psychoeducational intervention (FDPEI) for stroke survivors and family caregivers on functional and psychosocial health outcomes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18158500
Enrollment
40
Registered
2022-10-10
Start date
2020-12-07
Completion date
Unknown
Last updated
2023-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke Circulatory System Stroke, not specified as haemorrhage or infarction

Interventions

The programme will be conducted via a hybrid approach in two parts: structured face-to-face education when survivors are in hospital or rehabilitation facilities
and telephone follow-up counselling after survivor discharge. The intervention will be initiated after survivors become stable in the hospital. The randomisation method is block randomisation with a b
2) adaptation for caring and being cared for in basic activities of daily life
and (3) psychological adjustment and stress management. An information booklet will be designed in accordance with the intervention protocol. Every session will be delivered in 1 hour. There are 2 or

Sponsors

Chinese University of Hong Kong
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1. Feasibility, measured by: 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) 1.2. Attrition rates (calculated as the percentage of those participants not able to complete the study or the outcome assessment immediately post-intervention) 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) 2. Acceptability, open-ended questions, including the appropriateness of the intervention and the experiences of participating in the FDPEI, measured immediately post-intervention

Secondary

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

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 10, 2026