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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04687475
• Other study ID #: 19-112
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: The Cleveland Clinic
• Contact: Carli J Lehr, MD, MS
• Phone: 216-444-0962
• Email: lehrc[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Lung Transplant; Complications

Intervention

Other:
• Clinical Tool (Mobile Spirometry and Survey)
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.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung Allocation Score (LAS)	Change in LAS value at the first clinic visit triggered by the clinical tool	Through study completion, an average of 3-6 months (time spent on the lung transplant waiting list).
Secondary	Time to transplant	Measured in days (time spent on the lung transplant waiting list)	Through study completion, up to 1 year
Secondary	Survival to transplant	Binary outcome measure to indicate if individual survived to transplant	Through study completion, up to 1 year