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Clinical Tool for Cystic Fibrosis Waitlist Mortality

N/A

Waitlist Available

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

To be listed for lung transplant

Diagnosis of Cystic Fibrosis

Must not have

Diagnosis other than Cystic Fibrosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aimed to improve waitlist mortality in patients with cystic fibrosis by implementing a clinical tool.

Who is the study for?

This trial is for individuals with Cystic Fibrosis who are on the waitlist for a lung transplant and have bought a home spirometer. It's not suitable for those without Cystic Fibrosis, or people who can't read or use a computer/smartphone to access the required mobile app.

What is being tested?

The study is testing a clinical tool that includes mobile spirometry (a way to measure lung function) and surveys. The goal is to see if this tool can help reduce the number of patients with Cystic Fibrosis who die while waiting for a lung transplant.

What are the potential side effects?

Since this trial involves using a clinical tool rather than medication, traditional side effects like you'd expect from drugs aren't applicable here. However, there may be indirect effects related to data privacy concerns or stress from constant health monitoring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am on the waiting list for a lung transplant.

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...

My diagnosis is not Cystic Fibrosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Lung Allocation Score (LAS)

Secondary study objectives

Transplantation

Time to transplant

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Clinical Tool (Mobile Spirometry and Survey)Experimental Treatment1 Intervention

All subjects enrolled will be placed into the clinical tool arm. The clinical tool is comprised of a mobile application based assessment of home spirometry and a survey measuring patient reported outcomes.

0 / 3Eligibility criteria met