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NCT04687475 Clinical Trial

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
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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