Preliminary evaluation of a family-focused psychoeducational programme for stroke survivors and their family caregivers
| ISRCTN | ISRCTN18158500 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18158500 |
- Submission date
- 08/10/2022
- Registration date
- 10/10/2022
- Last edited
- 30/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Stroke is the first and second leading cause of death in China and worldwide, which can bring about a variety of physical and psychosocial disturbances for both stroke survivors and their family caregivers. A psychoeducational intervention seems to be an effective approach for them to improve their physical and psychosocial outcomes. Psychoeducation is an evidence-based intervention for patients and their loved ones that provides information and support to better understand and cope with illness. This study aims to develop and evaluate an appropriate theory-based family-focused approach to psychoeducational intervention to help improve psychosocial and physical health outcomes.
Who can participate?
People with stroke and their family caregivers, aged 18 years and over
What does the study involve?
Participants are randomly allocated to receive the family-focused psychoeducational intervention or usual care only.
What are the possible benefits and risks of participating?
It is expected that participants who receive this programme may improve their coping skills for disease management, which may improve functional and psychosocial outcomes accordingly. As this is a psychosocial and educational intervention, participants have few opportunities to suffer side effects or other risks
Where is the study run from?
The Chinese University of Hong Kong (Hong Kong)
When is the study starting and how long is it expected to run for?
November 2020 to February 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Huanyu Mou, mouhuanyu@link.cuhk.edu.hk
Contact information
Principal Investigator
Room 702, 7/F, Esther Lee Building
The Chinese University of Hong Kong
Shatin, N.T.
Hong Kong
-
Hong Kong
| Phone | +852 (0)63321157 |
|---|---|
| mouhuanyu@link.cuhk.edu.hk |
Study information
| Study design | Assessor-blinded two-arm (parallel-group) pilot-controlled trial with randomised allocation of study subjects and pre-test and post-test evaluative design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Effectiveness of a family-focused dyadic psychoeducational intervention (FDPEI) for stroke survivors and family caregivers on functional and psychosocial health outcomes |
| Study objectives | The overall aim of this study is to determine the feasibility, acceptability and effectiveness of a family-focused dyadic psychoeducational intervention (FDPEI) programme for stroke dyads (i.e., stroke survivors and their family caregivers). The study hypotheses are: 1. The family-focused dyadic psychoeducational intervention programme is feasible for stroke family dyads. 2. The family-focused dyadic psychoeducational intervention programme is acceptable for stroke family dyads. 3. The family-focused dyadic psychoeducational intervention programme can have significant effects on stroke dyads’ functional and psychosocial health outcomes immediately post-intervention. |
| Ethics approval(s) | Approved 02/11/2020, Joint CUHK-NTEC Clinical Research Ethics Committee (8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong; +852 (0)3505 3824; crec2@cuhk.edu.hk), ref: 2020.489-T |
| Health condition(s) or problem(s) studied | Stroke |
| Intervention | 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 block size of four. Face-to-face education This part will be conducted when patients in hospital or rehabilitation facilities (prior to the survivor's discharge), which consists of three sessions, namely, 1) overview of fundamental knowledge related to stroke; 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 3 days between two sessions, as a result, family dyads could have time to understand the intervention contents. Telephone follow-up counselling After the survivor's discharge, the follow-up family counselling will be conducted by the intervener via telephone contact weekly for 4 weeks. During each contact, the intervener encourages family dyads to express their encountered problems or stressful experience in their daily lives. The arising problems or issues (e.g. wrong caregiving behaviour, uncomfortable health status, or stressful feelings) will be appraised and discussed, and advice is given where needed. The counselling part is structured but not standardised, as it aims to respond to family dyads' individualised needs, which varied widely and cannot always be predicted. |
| Intervention type | Behavioural |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 02/11/2020 |
| Completion date | 27/02/2021 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 stroke survivor-family caregiver dyads |
| Total final enrolment | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 07/12/2020 |
| Date of final enrolment | 18/01/2021 |
Locations
Countries of recruitment
- China
Study participating centres
Huaiyin Region
Jinan
250021
China
Jinan, Shandong
Jinan
250031
China
Sponsor information
University/education
Esther Lee Building
Shatin, N.T.
Hong Kong
-
Hong Kong
| Phone | +852 (0)39439310 |
|---|---|
| huanyumou@cuhk.edu.hk | |
| Website | http://www.cuhk.edu.hk/english/index.html |
"ROR" |
https://ror.org/00t33hh48 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 07/07/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the principle of informed consent which indicated that the participants' personal data will not be public. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 21/12/2022 | 30/03/2023 | Yes | No |
Editorial Notes
30/03/2023: Publication reference added.
10/10/2022: Trial's existence confirmed by the Joint CUHK-NTEC Clinical Research Ethics Committee.
