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Clinical Trials/NCT04245228
NCT04245228
Completed
Not Applicable

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

Mayo Clinic1 site in 1 country60 target enrollmentJune 13, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress, Psychological
Sponsor
Mayo Clinic
Enrollment
60
Locations
1
Primary Endpoint
Acceptability
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 13, 2020
End Date
March 13, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cassie C. Kennedy, M.D.

Principal Investigator

Mayo Clinic

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

Outcomes

Primary Outcomes

Acceptability

Time Frame: after completion of the 12-week intervention or between 12-16 weeks after enrollment

Percentage of participants who completed the study intervention

Secondary Outcomes

  • Perceived Stress Scale (PSS)(after completion of the 12 week intervention or between 12-16 weeks after enrollment.)

Study Sites (1)

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