MedPath

Coaching Intervention for Caregivers of Persons With Stroke

Not Applicable
Conditions
Caregiver Burnout
Caregiver Stress Syndrome
Stroke, Acute
Interventions
Behavioral: Coaching
Registration Number
NCT04535284
Lead Sponsor
Thomas Jefferson University
Brief Summary

Caregivers of people with stroke experience strain that can reduce their quality of life. Caregivers are routinely engaged during hospital discharge for education and training related to the person with stroke. However, the critical period after stroke survivor's discharge is largely unsupported for the caregiver. This proposed study is a randomized controlled trial that will provide post-discharge support for caregivers using a health coaching program as compared to usual care and examine its effect of caregivers and people with stroke.

Detailed Description

Caregiver strain reduces quality of life and can increase the chance of unplanned hospital readmission for the person with stroke. Caregivers are routinely engaged during hospital discharge for education and training. However, the critical period after discharge is largely unsupported. The proposed research will integrate occupational therapy and telehealth to provide a post-discharge, caregiver-focused program, the "Health Coaching-in-Context" that consists of up to 10 sessions, arranged once-a-week or multiple times a week based on convenience of scheduling for up to 10 weeks. The program targets improved caregiver health and reduction in readmissions for stroke survivor. The study aims to examine the effects of the coaching program for caregivers as compared to usual care and evaluate the feasibility of study design. A pilot randomized controlled trial will be conducted with two parallel groups, "Health Coaching-in-Context" and usual care. A sample of up to 40 pairs, including up to 40 stroke survivors and their respective 40 caregivers will be recruited from University hospitals and randomly assigned after consenting. The occupational therapist, unaware of the group assignment, will administer assessments before and after the intervention, and at 4-week follow-up. Data will be collected on general information, readmissions, performance, self-efficacy, and quality of life.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
80
Inclusion Criteria
  • Survivor criteria: First-time stroke, discharged from hospital within the past 30 days.
  • Caregiver criteria: Informal caregiver primarily responsible for care (family member, friend, or partner), may or may not live in the same household. Passes cognition screen, willing to use teleconference using phone, tablet, or computer.
  • Both: 18 to 80 years of age, understand and speak English
Exclusion Criteria
  • Children
  • 81 years of age or older
  • Unable to understand and speak English
  • Does not provide consent
  • Caregiver does not pass cognition screen

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
CoachingCoachingHealth Coaching-in-Context" includes coaching by trained coaches up to 10 sessions over teleconference.
Primary Outcome Measures
NameTimeMethod
Canadian Occupational Performance MeasureWeek 15

Measure of performance and satisfaction with performance of daily tasks. Each domain score is out of 10, minimum is 1, and higher scores are better.

Secondary Outcome Measures
NameTimeMethod
Stroke Impact ScaleWeek 15

The impact of stroke on various areas of daily activities of the person with stroke. Range from 0 to 100, higher is better.

Revised Caregiver Self-efficacy scaleWeek 15

Measure of confidence with caregiving related tasks. 0 to 100 range for 15 items, higher score is better self-efficacy

Single-item life satisfaction scaleWeek 15

Life Satisfaction Evaluation. Lower scores are better, range from 1 to 4 Satisfaction with life - one question Quality of life evaluation Satisfaction with life - one question Quality of life evaluation Satisfaction with life - one question Satisfaction with life - one question

Re-admission90 day re-admission

Number of subjects readmitted. Lower is better.

Zarit Burden InterviewWeek 15

Burden experienced by caregiver while caring for person with stroke. Lower score is better, 22 items, range is 0 to 88.

WHO-BREF Quality of Life scaleWeek 15

World Health Organization-Brief Quality of life evaluation. Higher Scores are better. Scores in four domains 0 to 100 each

Trial Locations

Locations (1)

Thomas Jefferson University

🇺🇸

Philadelphia, Pennsylvania, United States

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