Family-centered Support Program for Caregivers of Stroke Survivors
1 other identifier
interventional
210
1 country
1
Brief Summary
The goal of this study is to evaluate the effect of a family-centered support program on the care burden, depressive symptoms, perceived social support, and quality of life of stroke survivor' caregivers and on care recipients' rehabilitation adherence and depressive symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Aug 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedFirst Submitted
Initial submission to the registry
December 13, 2022
CompletedFirst Posted
Study publicly available on registry
December 29, 2022
CompletedDecember 29, 2022
December 1, 2022
1.2 years
December 13, 2022
December 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (15)
Depressive symptoms
Depressive symptoms were measured using the Taiwanese Depression Scale.The range of total scores is between 0\~54, the scores higher than 19 indicated an increased risk of depression.
The outcome was assessed at baseline.
Caregiver care burden
The caregiver strain index (CSI) was used to measure caregiver care burden. The range of total scores is between 0\~13, the higher total scores indicated a higher care burden.
The outcome was assessed at baseline.
Perceived social support
Medical Outcome Study Social Support Survey- Taiwanese version was used to measure the perceived social support for caregivers of stroke survivors. The range of total scores is between 19\~95, and the higher full scores indicated a perception of better social support.
The outcome was assessed at baseline.
Caregivers' quality of life
Taiwanese version of the World Health Organization Quality of Life BREF(WHOQOL-BREF) was used to measure caregivers' quality of life. The range of total scores is between 4\~20, and the higher full scores indicated a better quality of life. WHOQOL-BREF was used to measure the quality of life of stroke survivors' caregivers.
The outcome was assessed at baseline.
Rehabilitation adherence
A single item of rehabilitation adherence measurement was used to measure stroke Patients' rehabilitation adherence levels. The range of scores is between 1\~5, and the highest scores indicated an optimal adherence level.
The outcome was assessed at baseline.
Change from baseline depressive symptoms at first month
Depressive symptoms were measured using the Taiwanese Depression Scale.The range of total scores is between 0\~54, the scores higher than 19 indicated an increased risk of depression.
The outcome was assessed at first month after inclusion.
Change from baseline caregiver care burden at first month
The caregiver strain index (CSI) was used to measure caregiver care burden. The range of total scores is between 0\~13, the higher total scores indicated a higher care burden.
The outcome was assessed at first month after inclusion.
Change from baseline perceived social support at first month
Medical Outcome Study Social Support Survey- Taiwanese version was used to measure the perceived social support for caregivers of stroke survivors. The range of total scores is between 19\~95, and the higher full scores indicated a perception of better social support.
The outcome was assessed at first month after inclusion.
Change from baseline caregivers' quality of life at first month
Taiwanese version of the World Health Organization Quality of Life BREF(WHOQOL-BREF) was used to measure caregivers' quality of life. The range of total scores is between 4\~20, and the higher full scores indicated a better quality of life.WHOQOL-BREF was used to measure the quality of life of stroke survivors' caregivers.
The outcome was assessed at first month after inclusion.
Change from baseline rehabilitation adherence at first month
A single item of rehabilitation adherence measurement was used to measure stroke patients' rehabilitation adherence levels. The range of scores is between 1\~5, and the highest scores indicated an optimal adherence level.
The outcome was assessed at first month after inclusion.
Change from baseline depressive symptoms at third month
Depressive symptoms were measured using the Taiwanese Depression Scale.The range of total scores is between 0\~54, the scores higher than 19 indicated an increased risk of depression.
The outcome was assessed at third after inclusion.
Change from baseline caregiver care burden at third month
The caregiver strain index (CSI) was used to measure caregiver care burden. The range of total scores is between 0\~13, the higher total scores indicated a higher care burden.
The outcome was assessed at third after inclusion.
Change from baseline perceived social support at third month
Medical Outcome Study Social Support Survey- Taiwanese version was used to measure the perceived social support for caregivers of stroke survivors. The range of total scores is between 19\~95, and the higher full scores indicated a perception of better social support.
The outcome was assessed at third after inclusion.
Change from baseline caregivers' quality of life at third month
Taiwanese version of the World Health Organization Quality of Life BREF (WHOQOL-BREF) was used to measure caregivers' quality of life. The range of total scores is between 4\~20, and the higher full scores indicated a better quality of life. WHOQOL-BREF was used to measure the quality of life of stroke survivors' caregivers.
The outcome was assessed at third after inclusion.
Change from baseline rehabilitation adherence at third month
A single item of rehabilitation adherence measurement was used to measure stroke patients' rehabilitation adherence levels. The range of scores is between 1\~5, and the highest scores indicated an optimal adherence level.
The outcome was assessed at third after inclusion.
Study Arms (2)
Family-centered support program for caregivers of stroke survivors
EXPERIMENTALParticipants receive usual hospital care and our intervention
No Intervention: Control group
NO INTERVENTIONParticipants receive only usual hospital care
Interventions
Once participants joined the family-centered support group, participants received 90-minute interventions, including an introduction to stroke and rehabilitation education, problem-solving skills training, and long-term care information. Investigators also invited participants to join the instant messaging application-based 24-h peer-support group for caregivers. On the second and fourth days after receiving the interventions, the researcher visited the participants to review and practice the content provided on the first day; each session was 30 to 40 minutes long. The researcher contacted the participants one week after participants joined the study to discuss their care difficulties or experiences and did so three times biweekly thereafter via the instant messaging application.
Eligibility Criteria
You may qualify if:
- Caregivers:
- Aged 20 years or older
- Primarily responsible for caring for the stroke survivor in the hospital and after discharge.
- Stroke survivors:
- Diagnosed with moderate stroke (National Institute of Health Stroke Scale ≥5 or Modified Rank in Scale ≥3), including ischemic and hemorrhagic stroke, via computed tomography or magnetic resonance imaging within one month. admitted to the stroke unit at a medical center
- Had a primary family caregiver.
You may not qualify if:
- Caregivers:
- Refusal to participate in the study
- Unable to communicate, for example, non-Chinese speakers
- Reported having been diagnosed with psychiatric illness (such as major depression) and undergoing treatment.
- Stroke survivors:
- Unstable vital signs
- Terminal illness
- Transfer to long-term care facilities after hospital discharge
- Self-reported having been diagnosed with psychiatric illness (such as major depression) and undergoing treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- wen yu Kuo, assistant professorlead
- National Science and Technology Councilcollaborator
- Chang Gung Memorial Hospitalcollaborator
Study Sites (1)
Chang Gung University of Science and Technology
Taoyuan District, 33303, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- To prevent contact between participants in the intervention and control groups, we allocated participants from the G ward to the intervention group and those from the H ward to the control group. Participants were not given information about the group allocations.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
December 13, 2022
First Posted
December 29, 2022
Study Start
August 16, 2021
Primary Completion
October 31, 2022
Study Completion
October 31, 2022
Last Updated
December 29, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share