Recruiting

Coaching Intervention

Sponsor:

Thomas Jefferson University

Code:

NCT04535284

Conditions

Caregiver Stress Syndrome

Caregiver Burnout

Stroke, Acute

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Coaching

Study Details

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.

Conditions

Caregiver Stress Syndrome

Caregiver Burnout

Stroke, Acute

Study ID

NCT04535284

Start date

Aug 24, 2020

Status verified date

Oct, 2021

Completion date

Jul 31, 2022

Anticipated

Primary completion date

Jul 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Coaching

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

no intervention: Usual Care

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

Coaching

"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.

Primary outcome measure

  • Canadian Occupational Performance Measure [ Time Frame: Week 1 ]
  • Canadian Occupational Performance Measure [ Time Frame: Week 12 ]
  • Canadian Occupational Performance Measure [ Time Frame: Week 15 ]

Central Contacts and Locations

Central contacts

Namrata Grampurohit, PhD

2063536054namrata.grampurohit@jefferson.edu

Erica Witoslawski, BS

2155030527exw086@jefferson.edu

Locations

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Namrata Grampurohit, PhD

206-353-6054namrata.grampurohit@jefferson.edu

More Information

Sponsor

Thomas Jefferson University

Last update posted

Oct 6, 2021

Last verified

Oct, 2021

Keywords

  • Caregiver
  • Stroke
  • Coaching
  • Stress
  • Self-efficacy
  • Re-admission
  • Burden

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2021-10-06.