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Lung Transplant Education for Cystic Fibrosis

N/A
Recruiting
Led By Kathleen Ramos, MD, MSc
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of cystic fibrosis
Be older than 18 years old
Must not have
People who are unable to provide informed consent
Unable to read or understand English or Spanish to complete surveys or access the website (currently only available in English and Spanish)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at baseline, 3-month and 6-month study visits
Awards & highlights
No Placebo-Only Group

Summary

This trial studies how people with cystic fibrosis use lung transplant educational resources to become more prepared for discussions and decisions about lung transplant. It also examines unique factors that affect people from communities with decreased access to transplant.

Who is the study for?
This trial is for individuals with cystic fibrosis whose lung function (FEV1) is less than half of what's expected. It's not open to those who've already had a lung transplant, can't consent for themselves, or don't understand English or Spanish well enough to use the resources and complete surveys.
What is being tested?
The study compares two educational resources on lung transplants: one designed by researchers and another that's publicly available. Over six months, participants will have Zoom sessions, take surveys, access a research website with educational content, and have a clinic visit audio-recorded to see how transplant talks are handled.
What are the potential side effects?
Since this trial focuses on education rather than medication or surgery, there aren't direct physical side effects. However, learning about lung transplants could cause emotional or psychological responses in participants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with cystic fibrosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am able to understand and agree to the study's procedures and risks.
Select...
I can read and understand either English or Spanish to complete surveys and access the website.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline, 3-month and 6-month study visits
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline, 3-month and 6-month study visits for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Preparedness for Shared Decision Making (PrepDM) Scale
Secondary study objectives
Confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey)
Decisional Conflict Scale
Generalized Anxiety Disorder 7-item (GAD-7) Scale
+2 more
Other study objectives
6-month assessment for Decisional Conflict Scale
6-month assessment for Likert-scale rating of preparedness to discuss lung transplant
6-month assessment for confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey)
+9 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Access to an investigator-designed web-based educational resource with information about lung transplant for three months.
Group II: Attention-controlActive Control1 Intervention
Access to a publicly available web-based educational resource with information about transplant for three months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Investigator-designed lung transplant education resource (Research Intervention)
2021
N/A
~60

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,817 Previous Clinical Trials
1,914,250 Total Patients Enrolled
24 Trials studying Cystic Fibrosis
52,875 Patients Enrolled for Cystic Fibrosis
National Institute of Nursing Research (NINR)NIH
600 Previous Clinical Trials
10,377,447 Total Patients Enrolled
2 Trials studying Cystic Fibrosis
260 Patients Enrolled for Cystic Fibrosis
Kathleen Ramos, MD, MScPrincipal InvestigatorUniversity of Washington
~81 spots leftby Sep 2026
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