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Active, Not Recruiting

NCT Number: NCT04687475

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Lung Transplant; Complications Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

The aim of this project is to implement a clinical tool utilizing predictors of mortality for patients with Cystic Fibrosis (CF) on the waiting list to identify candidates that should present for urgent medical care and, if appropriate, will prompt clinicians to update a candidate's lung allocation score (LAS), the score used to prioritize lung transplant candidates for transplant by medical urgency, and avoid undetected decline. The clinical tool consists of home spirometry measures and patient reported outcomes that is completed weekly on a mobile application device used clinically to track spirometry.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Cystic Fibrosis
  • To be listed for lung transplant
  • Has purchased home spirometer

Exclusion criteria

  • Diagnosis other than Cystic Fibrosis
  • Unable to read
  • Unable to use computer or smartphone device to access mobile application

Treatment and study plan

Clinical Tool (Mobile Spirometry and Survey)

Other

The clinical tool is a combination of home spirometry measurements and a patient survey measuring patient reported outcomes including the Cystic Fibrosis Respiratory Symptom Diary (CFRSD) and Chronic Respiratory Infection Symptom Score (CRISS©), with permission from the Seattle Quality of Life Group.

Primary outcomes

  1. Lung Allocation Score (LAS)

    Time frame: Through study completion, an average of 3-6 months (time spent on the lung transplant waiting list).

    Change in LAS value at the first clinic visit triggered by the clinical tool

Secondary outcomes

  1. Time to transplant

    Time frame: Through study completion, up to 1 year

    Measured in days (time spent on the lung transplant waiting list)

  2. Survival to transplant

    Time frame: Through study completion, up to 1 year

    Binary outcome measure to indicate if individual survived to transplant

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Dec 29, 2020
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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