10 Participants Needed

Clinical Tool for Cystic Fibrosis Waitlist Mortality

CJ
DW
Overseen ByDavid Weaver, BSN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The Cleveland Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Implementation of a Clinical Tool to Improve Waitlist Mortality in Patients With Cystic Fibrosis

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Mobile Spirometry and Survey for cystic fibrosis?

Research suggests that using point-of-care technologies, like mobile spirometry, can help detect rapid lung function decline earlier than standard methods. This early detection allows for timely intervention, potentially slowing disease progression in cystic fibrosis patients.12345

How does this treatment for cystic fibrosis differ from other treatments?

This treatment is unique because it involves a clinical tool that uses a predictive algorithm to detect rapid lung function decline in cystic fibrosis patients earlier than current methods. This allows for earlier intervention and potentially better outcomes, unlike traditional treatments that may not detect rapid decline as quickly.12367

Eligibility Criteria

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.

Inclusion Criteria

I am on the waiting list for a lung transplant.
You have bought a home spirometer.
I have been diagnosed with Cystic Fibrosis.

Exclusion Criteria

Unable to read
Unable to use computer or smartphone device to access mobile application
My diagnosis is not Cystic Fibrosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Participants use a mobile application for home spirometry and patient-reported outcomes to track health status and update lung allocation scores.

3-6 months
Weekly assessments via mobile application

Follow-up

Participants are monitored for changes in lung allocation score and survival to transplant.

Up to 1 year

Treatment Details

Interventions

  • Mobile Spirometry and Survey
Trial OverviewThe 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials
1,072
Recruited
1,377,000+

Findings from Research

A randomized controlled trial involving 402 cystic fibrosis patients will assess the effectiveness of telemonitoring combined with behavior change interventions over 18 months, focusing on adherence to inhalation therapies and lung function.
The primary goal is to determine if continuous monitoring and support can reduce the time to the first pulmonary exacerbation, which is crucial for improving patient outcomes in cystic fibrosis.
A multi-centre, randomized, controlled trial on coaching and telemonitoring in patients with cystic fibrosis: conneCT CF.Thee, S., Stahl, M., Fischer, R., et al.[2021]

References

Risk factors for lung function decline in a large cohort of young cystic fibrosis patients. [2022]
Early Detection of Rapid Cystic Fibrosis Disease Progression Tailored to Point of Care: A Proof-of-Principle Study. [2020]
Improving Detection of Rapid Cystic Fibrosis Disease Progression-Early Translation of a Predictive Algorithm Into a Point-of-Care Tool. [2020]
Patient-reported symptoms and functioning as indicators of mortality in advanced cystic fibrosis: A new tool for referral and selection for lung transplantation. [2018]
A multi-centre, randomized, controlled trial on coaching and telemonitoring in patients with cystic fibrosis: conneCT CF. [2021]
Cystic Fibrosis Mortality in Childhood. Data from European Cystic Fibrosis Society Patient Registry. [2019]
Telehealth spirometry for children with cystic fibrosis. [2020]