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

NCT04687475 | Active Not Recruiting

• 1 other identifier: 19-112
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cystic Fibrosis; Lung Transplant; Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time to transplant

  Through study completion, up to 1 year

• Survival to transplant

  Through study completion, up to 1 year

Study Arms (1)

Clinical Tool (Mobile Spirometry and Survey)

EXPERIMENTAL

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.

Other: Clinical Tool (Mobile Spirometry and Survey)

Interventions

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.

Clinical Tool (Mobile Spirometry and Survey)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 29, 2020
• Study Start: April 20, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)