Wellness Coaching for Caregivers of Thoracic Transplant Candidates

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stress, Psychological, Caregiver Burden

Intervention / Treatment
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* Behavioral: Wellness Coach


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregiver, Heart Transplant, Lung Transplant, Stress