Back to resultsWellness Coaching for Caregivers of Thoracic Transplant Candidates
Primary Purpose
Stress, Psychological, Caregiver Burden
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wellness Coach
Sponsored by
About this trial
This is an interventional treatment trial for Stress, Psychological focused on measuring Caregiver, Heart Transplant, Lung Transplant, Stress
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual Care Group
Wellness Coaching Intervention
Arm Description
Routine caregiver transplant education
Caregivers will be assigned a wellness coach
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04245228
Brief Title
Wellness Coaching for Caregivers of Thoracic Transplant Candidates
Official Title
Does a Pre-transplant Health Coaching Intervention for Informal Caregivers of Adult Heart or Lung Transplant Candidates Improve Caregiver-Reported Outcomes?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 13, 2020 (Actual)
Primary Completion Date
October 20, 2022 (Actual)
Study Completion Date
March 13, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Caregiver Burden
Keywords
Caregiver, Heart Transplant, Lung Transplant, Stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care Group
Arm Type
No Intervention
Arm Description
Routine caregiver transplant education
Arm Title
Wellness Coaching Intervention
Arm Type
Experimental
Arm Description
Caregivers will be assigned a wellness coach
Intervention Type
Behavioral
Intervention Name(s)
Wellness Coach
Intervention Description
Trained in motivational interviewing who will call the patient weekly for 12 sessions for an approximately 30-minute intervention
Primary Outcome Measure Information:
Title
Acceptability and Feasibility
Description
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.
Time Frame
after completion of the 12 week intervention or between 12-16 weeks after enrollment.
Secondary Outcome Measure Information:
Title
Perceived Stress Scale (PSS)
Description
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).
Time Frame
after completion of the 12 week intervention or between 12-16 weeks after enrollment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cassie Kennedy, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Wellness Coaching for Caregivers of Thoracic Transplant Candidates
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