Back to resultsFamily-centered Support Program for Caregivers of Stroke Survivors
Primary Purpose
Stroke, Caregiver Burden
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Family-centered support program for caregivers of stroke survivors
Sponsored by
About this trial
This is an interventional supportive care trial for Stroke focused on measuring family-centered intervention
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Chang Gung University of Science and Technology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Family-centered support program for caregivers of stroke survivors
No Intervention: Control group
Arm Description
Participants receive usual hospital care and our intervention
Participants receive only usual hospital care
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05668169
First Posted
December 13, 2022
Last Updated
December 20, 2022
Sponsor
wen yu Kuo, assistant professor
Collaborators
National Science and Technology Council, Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05668169
Brief Title
Family-centered Support Program for Caregivers of Stroke Survivors
Official Title
Family-centered Support Program for Caregivers of Stroke Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
August 16, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
wen yu Kuo, assistant professor
Collaborators
National Science and Technology Council, Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
The family-centered support program included stroke and rehabilitation education, problem-solving skills training, long-term care information support, and instant messaging applications-based 24-h peers-support group for caregivers.
Investigators hypothesized that (1) Compared with those in the control group, caregivers who undergo a family-centered support program have lower care burdens, do not have a high risk of depression, and perceive better social support and quality of life; (2) Compared with those in the control group, care recipients in the family-centered support group have ideal rehabilitation adherence and are not at a high risk of depression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Caregiver Burden
Keywords
family-centered intervention
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The family-centered support program included four components:
(A) Stroke and rehabilitation education. (B) Problem-solving skills training. (C) Long-term care information support. (D) Instant messaging application-based 24-h peers-support group for caregivers.
Masking
Participant
Masking Description
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.
Allocation
Non-Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Family-centered support program for caregivers of stroke survivors
Arm Type
Experimental
Arm Description
Participants receive usual hospital care and our intervention
Arm Title
No Intervention: Control group
Arm Type
No Intervention
Arm Description
Participants receive only usual hospital care
Intervention Type
Other
Intervention Name(s)
Family-centered support program for caregivers of stroke survivors
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depressive symptoms
Description
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.
Time Frame
The outcome was assessed at baseline.
Title
Caregiver care burden
Description
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.
Time Frame
The outcome was assessed at baseline.
Title
Perceived social support
Description
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.
Time Frame
The outcome was assessed at baseline.
Title
Caregivers' quality of life
Description
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.
Time Frame
The outcome was assessed at baseline.
Title
Rehabilitation adherence
Description
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.
Time Frame
The outcome was assessed at baseline.
Title
Change from baseline depressive symptoms at first month
Description
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.
Time Frame
The outcome was assessed at first month after inclusion.
Title
Change from baseline caregiver care burden at first month
Description
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.
Time Frame
The outcome was assessed at first month after inclusion.
Title
Change from baseline perceived social support at first month
Description
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.
Time Frame
The outcome was assessed at first month after inclusion.
Title
Change from baseline caregivers' quality of life at first month
Description
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.
Time Frame
The outcome was assessed at first month after inclusion.
Title
Change from baseline rehabilitation adherence at first month
Description
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.
Time Frame
The outcome was assessed at first month after inclusion.
Title
Change from baseline depressive symptoms at third month
Description
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.
Time Frame
The outcome was assessed at third after inclusion.
Title
Change from baseline caregiver care burden at third month
Description
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.
Time Frame
The outcome was assessed at third after inclusion.
Title
Change from baseline perceived social support at third month
Description
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.
Time Frame
The outcome was assessed at third after inclusion.
Title
Change from baseline caregivers' quality of life at third month
Description
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.
Time Frame
The outcome was assessed at third after inclusion.
Title
Change from baseline rehabilitation adherence at third month
Description
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.
Time Frame
The outcome was assessed at third after inclusion.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Chang Gung University of Science and Technology
City
Taoyuan
ZIP/Postal Code
33303
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Family-centered Support Program for Caregivers of Stroke Survivors
We'll reach out to this number within 24 hrs