Wellness Coaching for Caregivers of Thoracic Transplant Candidates

Stress, Psychological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04245228
• Other study ID #: 19-008807
• Status: Completed
• Phase: N/A
• Start date: June 13, 2020
• Est. completion date: March 13, 2023

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 13, 2023
• Est. primary completion date: October 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Caregiver Burden
• Stress, Psychological

Intervention

Behavioral:
• Wellness Coach
Trained in motivational interviewing who will call the patient weekly for 12 sessions for an approximately 30-minute intervention

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability and Feasibility	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.	after completion of the 12 week intervention or between 12-16 weeks after enrollment.
Secondary	Perceived Stress Scale (PSS)	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).	after completion of the 12 week intervention or between 12-16 weeks after enrollment.