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Recruiting NCT05426200

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

No phase Interventional Lung Transplant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Health Coaching.
Who it may be relevant to
Registry conditions: Lung Transplant. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • Change in Score on Chronic Respiratory Disease Questionnaire (CRQ) Mastery Subdomain [Time frame: Baseline, 12-16 Week Follow-up]
  • Change in Score on Chronic Respiratory Disease Questionnaire (CRQ) Emotional Function Subdomain [Time frame: Baseline, 12-16 Week Follow-up]
Secondary outcome measures (2)
  • Post-Transplant Quality of Life Chronic Respiratory Disease Questionnaire (CRQ) Composite [Time frame: Post-Transplant Follow-up, on Average 1 Year]
  • Intervention Feasibility and Acceptability via Qualitative Surveys and Interviews [Time frame: 12-16 Week Follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 3 centers
  • Mayo Clinic — Jacksonville
  • Mayo Clinic — Rochester
  • University of Washington — Seattle

Identifiers

NCT: NCT05426200 · 21-002675

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗