NCT04535284

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

August 24, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 1, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

October 6, 2021

Status Verified

October 1, 2021

Enrollment Period

1.9 years

First QC Date

August 6, 2020

Last Update Submit

October 4, 2021

Conditions

Caregiver Stress SyndromeCaregiver BurnoutStroke, Acute

Keywords

CaregiverStrokeCoachingStressSelf-efficacyRe-admissionBurden

Outcome Measures

Primary Outcomes (3)

  • Canadian Occupational Performance Measure

    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.

    Week 1

  • Canadian Occupational Performance Measure

    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.

    Week 12

  • Canadian Occupational Performance Measure

    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.

    Week 15

Secondary Outcomes (18)

  • Re-admission

    30 day re-admission

  • Re-admission

    60 day re-admission

  • Re-admission

    90 day re-admission

  • Revised Caregiver Self-efficacy scale

    Week 1

  • Revised Caregiver Self-efficacy scale

    Week 12

  • +13 more secondary outcomes

Study Arms (2)

Coaching

EXPERIMENTAL

Health Coaching-in-Context" includes coaching by trained coaches up to 10 sessions over teleconference.

Behavioral: Coaching

Usual Care

NO INTERVENTION

The usual care group does not get any intervention but continues with any of their usual activities that would otherwise would have been provided to them.

Interventions

CoachingBEHAVIORAL

"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 through occupational therapy coaching.

Also known as: Health Coaching in Context
Coaching

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Children
  • years of age or older
  • Unable to understand and speak English
  • Does not provide consent
  • Caregiver does not pass cognition screen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Caregiver BurdenStroke

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Namrata Grampurohit, PhD

CONTACT

2063536054namrata.grampurohit@jefferson.edu

Erica Witoslawski, BS

CONTACT

2155030527exw086@jefferson.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessor will be blinded to treatment group allocation
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single-blind randomized controlled trial design with two parallel groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2020

First Posted

September 1, 2020

Study Start

August 24, 2020

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

October 6, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Data will be shared within the research team. De-identified data will be made publicly available on a repository.

Locations

US(1)