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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at baseline, 3-month and 6-month study visits

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at baseline, 3-month and 6-month study visits

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Preparedness for Shared Decision Making (PrepDM) Scale

Secondary outcome measures

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 outcome measures

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

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,741 Previous Clinical Trials

1,847,628 Total Patients Enrolled

24 Trials studying Cystic Fibrosis

45,735 Patients Enrolled for Cystic Fibrosis

National Institute of Nursing Research (NINR)NIH

580 Previous Clinical Trials

10,376,429 Total Patients Enrolled

2 Trials studying Cystic Fibrosis

260 Patients Enrolled for Cystic Fibrosis

Kathleen Ramos, MD, MScPrincipal InvestigatorUniversity of Washington

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what geographical areas are the trials for this experiment being conducted?

"Nine medical centres are taking part in this trial, including National Jewish Health in Denver, Yale University in New Haven and the University of Kansas in Kansas City. Other participating sites can be found across the country."

Answered by AI

Is there still room for participation in this clinical investigation?

"Affirmative. The information available on clinicaltrials.gov demonstrates that this medical experiment is actively recruiting patients, having been first posted on the 6th of September 2023 and updated most recently on 8th of September 2023. In total, 132 participants are needed across 9 different locations."

Answered by AI

What is the tally of participants registering for this medical experiment?

"Affirmative, the information present on clinicaltrials.gov indicates that this trial is in the process of recruiting participants. The study was announced on September 6th 2023 and last updated two days later; 132 individuals need to be recruited from 9 different medical sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Lung Transplant READY CF 2: A Multi-site RCT

Kathleen Ramos 2023. "Lung Transplant READY CF 2: A Multi-site RCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06030206.

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