Wellness Coaching for Caregivers of Thoracic Transplant Candidates

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT04245228

Collaborator

(none)

120

Enrollment

Location

Arms

30.6

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Researchers are studying the effects of a health coaching intervention on the stress and burden of caregivers of patients awaiting heart or lung transplant.

Condition or Disease	Intervention/Treatment	Phase
Stress, Psychological Caregiver Burden	Behavioral: Wellness Coach	N/A

Detailed Description

This is a randomized trial of health coaching compared to usual care. Caregivers for patients on the adult heart or adult lung transplant waiting list at the Mayo Clinic will undergo informed consent. Consenting participants will be randomized to weekly, 30-minute telephone calls for twelve weeks or usual care. Questionnaires and demographic information will be collected at baseline and after 12 weeks.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Does a Pre-transplant Health Coaching Intervention for Informal Caregivers of Adult Heart or Lung Transplant Candidates Improve Caregiver-Reported Outcomes?

Actual Study Start Date :

Jun 13, 2020

Anticipated Primary Completion Date :

Nov 30, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual Care Group Routine caregiver transplant education
Experimental: Wellness Coaching Intervention Caregivers will be assigned a wellness coach	Behavioral: Wellness Coach Trained in motivational interviewing who will call the patient weekly for 12 sessions for an approximately 30-minute intervention

Arm

Intervention/Treatment

No Intervention: Usual Care Group

Routine caregiver transplant education

Experimental: Wellness Coaching Intervention

Caregivers will be assigned a wellness coach

Behavioral: Wellness Coach

Trained in motivational interviewing who will call the patient weekly for 12 sessions for an approximately 30-minute intervention

Outcome Measures

Primary Outcome Measures

Acceptability and Feasibility [after completion of the 12 week intervention or between 12-16 weeks after enrollment.]
A post-intervention qualitative survey will be administered with both open-ended and Likert scale questions to assess participants' regard for the intervention, participants' opinions on the frequency and duration of intervention, and assess for any recommended changes to the intervention.

Secondary Outcome Measures

Perceived Stress Scale (PSS) [after completion of the 12 week intervention or between 12-16 weeks after enrollment.]
The Perceived Stress Scale (PSS) is a self-assessment tool used to measure stress. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress. We will evaluate the difference in the change in PSS of intervention group (adjusted for baseline) compared to the change in PSS for the usual care (adjusting for baseline).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

18 years or older who are the primary caregivers of patients listed (active, deferred, or temporarily inactive) for lung, heart/lung, or heart transplantation at Mayo Clinic in Rochester and Jacksonville, FL