Family-centered Support Program for Caregivers of Stroke Survivors

NCT ID: NCT05668169

Last Updated: 2022-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-16

Study Completion Date

2022-10-31

Brief Summary

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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

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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.

Conditions

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Stroke Caregiver Burden

Keywords

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family-centered intervention

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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Family-centered support program for caregivers of stroke survivors

Participants receive usual hospital care and our intervention

Group Type EXPERIMENTAL

Family-centered support program for caregivers of stroke survivors

Intervention Type OTHER

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.

No Intervention: Control group

Participants receive only usual hospital care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Family-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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Science and Technology Council

FED

Sponsor Role collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role collaborator

wen yu Kuo, assistant professor

OTHER

Sponsor Role lead

Responsible Party

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wen yu Kuo, assistant professor

assistant professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Chang Gung University of Science and Technology

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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MOST 110-2314-B-255-001 -

Identifier Type: -

Identifier Source: org_study_id