Wellness Coaching for Caregivers of Thoracic Transplant Candidates

NCT ID: NCT04245228

Last Updated: 2024-09-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-13

Study Completion Date

2023-11-30

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.

Conditions

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Stress, Psychological Caregiver Burden

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual Care Group

Routine caregiver transplant education

Group Type NO_INTERVENTION

No interventions assigned to this group

Wellness Coaching Intervention

Caregivers will be assigned a wellness coach

Group Type EXPERIMENTAL

Wellness Coach

Intervention Type BEHAVIORAL

Trained in motivational interviewing who will call the patient weekly for 12 sessions for an approximately 30-minute intervention

Interventions

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Wellness Coach

Trained in motivational interviewing who will call the patient weekly for 12 sessions for an approximately 30-minute intervention

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Cassie C. Kennedy, M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cassie Kennedy, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R03HL155040

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-008807

Identifier Type: -

Identifier Source: org_study_id

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