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

Not Applicable

Recruiting

• Conditions: Cystic Fibrosis; Lung Transplant; Complications
• Interventions: Other: Clinical Tool (Mobile Spirometry and Survey)

• Registration Number: NCT04687475
• Lead Sponsor: The Cleveland Clinic

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2020-04-20
• Study First Submitted: 2020-12-17
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-29
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-10
• Last Update Posted: 2023-08-14
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clinical Tool (Mobile Spirometry and Survey)	Clinical Tool (Mobile Spirometry and Survey)	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.

Primary Outcome Measures

Name	Time	Method
Lung Allocation Score (LAS)	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 Outcome Measures

Name	Time	Method
Time to transplant	Through study completion, up to 1 year	Measured in days (time spent on the lung transplant waiting list)
Survival to transplant	Through study completion, up to 1 year	Binary outcome measure to indicate if individual survived to transplant

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States