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N/A N=52 Randomized Double-blind Other

Lung Transplant READY Pilot Study

Cystic Fibrosis

Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Feasibility of Participants Completing 2-week Study Visit — 25; 25; 0 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Investigator-designed lung transplant education resource (Research Intervention) (Behavioral); Publicly available transplant education resource (Attention Control) (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Washington
Primary completion
Nov 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Feasibility of Participants Completing 2-week Study Visit
25; 25; 0
PRIMARY
Preparedness for Shared Decision Making (PrepDM) Scale
71; 57 0.02 sig
SECONDARY
Confidence-weighted True False Knowledge About Lung Transplant (14-question Investigator-designed Survey)
11.6; 8.8 0.15
SECONDARY
Decisional Conflict Scale
-12; -11 0.81
SECONDARY
Likert-scale Rating of Preparedness to Discuss Lung Transplant (0-4)
3.4; 3.1 0.15
SECONDARY
Patient Health Questionnaire (PHQ-9)
0.16; 0.12
SECONDARY
Patient Health Questionnaire (PHQ-9)
0.16; 0.12
SECONDARY
Generalized Anxiety Disorder 7-item (GAD-7) Scale
0.08; 0.16
SECONDARY
Generalized Anxiety Disorder 7-item (GAD-7) Scale
0.08; 0.16

Summary

Lung transplant is an option for treating end-stage lung disease in cystic fibrosis (CF). More than half of people with CF who die without a lung transplant were never referred for consideration. Patient preference not to undergo lung transplant may account for 25-40% of decisions to defer referral. Increasing awareness of lung transplant among people with CF, and promoting understanding of the risks and benefits of transplant, can potentially reduce the number of people with CF who die without a lung transplant. The CF Foundation (CFF) lung transplant referral guidelines were developed to optimize the timing of referral for lung transplant. These guidelines recommend annual conversations with CF patients once their forced expiratory volume in one second (FEV1) is <50% predicted. Considering lung transplant as a treatment option ahead of when it is medically needed will allow more time to learn about lung transplant and address any barriers to lung transplant that may exist. Investigators are interested in understanding how people with CF use lung transplant educational resources and how one prepares for having discussions and/or making decisions about lung transplant as a treatment option for advanced CF. The purpose of this study is to test whether a research website improves patient preparedness for discussions about lung transplant. Study involvement will span 4 weeks and study procedures will involve the following: * Three Zoom interview sessions (30-60 minutes each) * Survey assessments * Access to a research website that contains educational resources about lung transplant (goal of 4 hours of use over the 4 week study period)

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of cystic fibrosis
  • FEV1 less than or equal to 50% predicted (unless referred per MD recommendation)

Exclusion Criteria

  • Patients unable to provide informed consent
  • Patients who are lung transplant recipients
  • Unable to read or understand English to complete surveys or access the websites (currently only available in English)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05135156). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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