Pre-transplant Health Coaching to Improve Patient-Reported Outcomes in Lung Transplant Candidates

NCT ID: NCT05426200

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-25

Study Completion Date

2027-01-31

Brief Summary

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To examine the effectiveness of an individual health coaching intervention for lung transplant candidates. This intervention will include up to 12 health coaching sessions via phone call over a 12-16 week period. This will be compared to a usual care group the receives pre-transplant care and education alone.

Detailed Description

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Conditions

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Lung Transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Health Coaching

Patient will work with a health coach to improve self-management skills, and receive usual pre-transplant education.

Group Type EXPERIMENTAL

Health Coaching

Intervention Type BEHAVIORAL

Patients will work with a health coach by telephone for up to 12 sessions over a 12-16 week period.

Control

Patients will receive usual pre-transplant education.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Health Coaching

Patients will work with a health coach by telephone for up to 12 sessions over a 12-16 week period.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Waitlisted or deferred for lung transplantation at Mayo Clinic Rochester, Mayo Clinic Florida, or University of Washington

Exclusion Criteria

* Under 18 years old
* Non-English speaking, nonverbal, or extremely hard of hearing
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Cassie C. Kennedy, M.D.

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cassie C Kennedy, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Jacksonville, Florida, United States

Site Status RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

University of Washington

Seattle, Washington, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Cassie C Kennedy, MD

Role: CONTACT

507-266-3958

Cassie L Zell, MA

Role: CONTACT

507-266-7765

Facility Contacts

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Sadia Z Shah, MD, MBA

Role: primary

904-956-3271

Cassie C Kennedy, MD

Role: primary

507-266-3958

Cassie L Zell, MA

Role: backup

507-266-7765

Erika D Lease, MD

Role: primary

206-598-5668

Other Identifiers

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21-002675

Identifier Type: -

Identifier Source: org_study_id

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