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Family-centered Support Program for Caregivers of Stroke Survivors

Family-centered Support Program for Caregivers of Stroke Survivors

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05668169
Enrollment
210
Registered
2022-12-29
Start date
2021-08-16
Completion date
2022-10-31
Last updated
2022-12-29

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

Conditions

Caregiver Burden, Stroke

Keywords

family-centered intervention

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.

Interventions

OTHERFamily-centered support program for caregivers of stroke survivors

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.

Sponsors

National Science and Technology Council
CollaboratorFED
Chang Gung Memorial Hospital
CollaboratorOTHER
wen yu Kuo, assistant professor
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

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.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Caregivers: * Aged 20 years or older * Primarily responsible for caring for the stroke survivor in the hospital and after discharge. 2. 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

1. 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. 2. 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.

Design outcomes

Primary

MeasureTime frameDescription
Caregiver care burdenThe outcome was assessed at baseline.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.
Depressive symptomsThe outcome was assessed at baseline.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.
Perceived social supportThe outcome was assessed at baseline.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 lifeThe outcome was assessed at baseline.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 adherenceThe outcome was assessed at baseline.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 monthThe outcome was assessed at first month after inclusion.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 monthThe outcome was assessed at first month after inclusion.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 monthThe outcome was assessed at first month after inclusion.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 monthThe outcome was assessed at first month after inclusion.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 monthThe outcome was assessed at first month after inclusion.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 monthThe outcome was assessed at third after inclusion.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 monthThe outcome was assessed at third after inclusion.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 monthThe outcome was assessed at third after inclusion.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 monthThe outcome was assessed at third after inclusion.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 monthThe outcome was assessed at third after inclusion.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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026