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

Study Overview

• Status: Recruiting
• Conditions: Cystic Fibrosis; Lung Transplant; Complications
• Intervention / Treatment: Other: Clinical Tool (Mobile Spirometry and Survey)

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carli J Lehr, MD, MS; Phone Number: 216-444-0962; Email: lehrc@ccf.org
• Study Contact Backup: Name: David Weaver, BSN; Phone Number: 216-445-6671; Email: weaverd@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: Carli J Lehr, MD, MS; Phone Number: 216-444-0962; Email: lehrc@ccf.org
      • Contact: David Weaver, BSN; Phone Number: 216-445-6671; Email: weaverd@ccf.org
      • Principal Investigator: Carli J Lehr, MD, MS
      • Sub-Investigator: Maryam Valapour, MD, MPP
      • Sub-Investigator: Elliott Dasenbrook, MD, MHS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2020
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: December 23, 2020
• First Posted (Actual): December 29, 2020

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: 19-112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No