Wellness Coaching for Caregivers of Thoracic Transplant Candidates

Not Applicable

Completed

• Conditions: Caregiver Burden; Stress, Psychological
• Interventions: Behavioral: Wellness Coach

• Registration Number: NCT04245228
• Lead Sponsor: Mayo Clinic

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.

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 Timeline

• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-01-27
• Study First Posted: 2020-01-28
• Study Start: 2020-06-13
• Primary Completion: 2022-10-20
• Study Completion: 2023-03-13
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Exclusion Criteria

• Individuals younger than 18 years
• Non-English speaking, non-verbal, or extremely hard of hearing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wellness Coaching Intervention	Wellness Coach	Caregivers will be assigned a wellness coach

Primary Outcome Measures

Name	Time	Method
Acceptability	after completion of the 12-week intervention or between 12-16 weeks after enrollment	Percentage of participants who completed the study intervention

Secondary Outcome Measures

Name	Time	Method
Perceived Stress Scale (PSS)	after completion of the 12 week intervention or between 12-16 weeks after enrollment.	Perceived Stress Scale-10 (PSS-10) is a 10-item tool to evaluate perception of stress during the past month (Cronbach α: 0.74-0.91). 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. Questions are scored 0-4 with scores of 0-13 indicate low; 14-26 indicate moderate; and 27 and above indicate high stress. We will evaluate the PSS of intervention group compared to the change in PSS for the usual care.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States