Clinical Tool for Cystic Fibrosis Waitlist Mortality

Overseen By David Weaver, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Non-cystic fibrosis, Illiteracy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool designed to assist individuals with cystic fibrosis who are awaiting a lung transplant. The tool, called Mobile Spirometry and Survey, uses a mobile app to track lung function at home with a spirometer (a device that measures breathing ability) and gathers health information through surveys. It aims to improve survival chances while on the transplant waitlist. Individuals with cystic fibrosis who are listed for a lung transplant and own a home spirometer might find this study suitable. Participants must use a smartphone or computer to access the app. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance transplant outcomes.

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 prior data suggests that this clinical tool is safe for patients with cystic fibrosis?

Research has shown that using mobile spirometry, a method to check lung function at home, is safe for people with cystic fibrosis. Studies have found this digital method to be as reliable as clinic-based tests. In one study, home spirometry did not cause harm. Another study demonstrated that smartphone apps for monitoring lung function were safe and provided useful information without issues.

Overall, patients have managed mobile spirometry and digital health tools effectively, with no major reports of negative effects. This suggests these tools are safe for managing cystic fibrosis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it introduces a new way to monitor and potentially improve outcomes for cystic fibrosis patients on waitlists. Unlike traditional methods that require frequent hospital visits, this approach leverages mobile spirometry and patient-reported surveys, allowing for continuous at-home assessment of lung function. This not only provides a more comprehensive picture of a patient's health over time but also empowers patients to take an active role in managing their condition. By streamlining data collection and enhancing patient engagement, this trial could lead to more personalized and timely interventions.

What evidence suggests that this clinical tool is effective for improving waitlist mortality in cystic fibrosis patients?

Studies have shown that using mobile spirometry, a tool for measuring lung function at home, along with patient surveys, can help people with cystic fibrosis (CF) manage their condition better. In this trial, all participants will use the clinical tool arm, which includes mobile spirometry and surveys. Research indicates that patients using home spirometry monitored their lung health more effectively, leading to better health outcomes. For example, regularly checking lung function at home can help identify problems early and improve communication with healthcare providers. One study found that incorporating these tools into telemedicine improved health results for CF patients. Overall, mobile spirometry and surveys offer a promising way to help people with CF manage their health. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Mobile Spirometry and Survey

Trial Overview 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.

How Is the Trial Designed?

Group I: Clinical Tool (Mobile Spirometry and Survey) Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11757947/

The Long-Term Uptake of Home Spirometry in Regular ... This study included all people with CF who measured their lung function at home with the RMP. Home spirometry and symptom survey data of all ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8660127/

Real-World Outcomes in Cystic Fibrosis Telemedicine ... The pandemic presented an unprecedented opportunity to assess the impact of the interdisciplinary telemedicine model on clinical CF outcomes.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0954611122002359

Clinical outcomes of digital health in adults with cystic fibrosis The aim of this study was to assess the long-term clinical impact of the application of e-health as part of a virtual model of care in patients with Cystic ...

4. cysticfibrosisnewstoday.com cysticfibrosisnewstoday.com/news/home-spirometry-benefit-cystic-fibrosis-patients-study/

At-home spirometry could benefit cystic fibrosis patients Adherence to at-home spirometry within three days before appointments was 55%, with better adherence at CF centers. “Our study suggests that ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1569199321021147

Quality of home spirometry performance amongst adults ... In this study, we compare the quality of unsupervised home spirometry performed by adults with CF with a wide range of lung function and age.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8464351/

A comparison of clinic and home spirometry as longtudinal ... This secondary analysis of a CF study (eICE) evaluates whether there are cross-sectional or longitudinal differences between home and clinic spirometry.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06147778

Performances and Safety of MuCopilot, a Digital Tool for ... The study aims to evaluate MuCopilot, a smartphone application to measure objective data on lung function (cough and dyspnea tests), global exercise ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1569199325007660

Remote monitoring of cystic fibrosis lung disease in ... This study aimed to evaluate the use of home-based spirometry and antibiotic monitoring for assessing lung function trends and treatment patterns in ...