Clinical trial NCT05668169: Family-centered Support Program for Caregivers of Stroke Survivors
Official title: Family-centered Support Program for Caregivers of Stroke Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Caregiver Burden
Keywords: family-centered intervention
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council
name: Chang Gung Memorial Hospital
First posted: 2022-12-29
Enrollment: 210
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Depressive symptoms
timeFrame: The outcome was assessed at baseline.
measure: Caregiver care burden
timeFrame: The outcome was assessed at baseline.
measure: Perceived social support
timeFrame: The outcome was assessed at baseline.
measure: Caregivers' quality of life
timeFrame: The outcome was assessed at baseline.
measure: Rehabilitation adherence
timeFrame: The outcome was assessed at baseline.
measure: Change from baseline depressive symptoms at first month
timeFrame: The outcome was assessed at first month after inclusion.
measure: Change from baseline caregiver care burden at first month
timeFrame: The outcome was assessed at first month after inclusion.
measure: Change from baseline perceived social support at first month
timeFrame: The outcome was assessed at first month after inclusion.
measure: Change from baseline caregivers' quality of life at first month
timeFrame: The outcome was assessed at first month after inclusion.
measure: Change from baseline rehabilitation adherence at first month
timeFrame: The outcome was assessed at first month after inclusion.
measure: Change from baseline depressive symptoms at third month
timeFrame: The outcome was assessed at third after inclusion.
measure: Change from baseline caregiver care burden at third month
timeFrame: The outcome was assessed at third after inclusion.
measure: Change from baseline perceived social support at third month
timeFrame: The outcome was assessed at third after inclusion.
measure: Change from baseline caregivers' quality of life at third month
timeFrame: The outcome was assessed at third after inclusion.
measure: Change from baseline rehabilitation adherence at third month
timeFrame: The outcome was assessed at third after inclusion.
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung University of Science and Technology
Study officials:
References: