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

Primary Purpose

Cystic Fibrosis, Lung Transplant; Complications

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Clinical Tool (Mobile Spirometry and Survey)

About this trial

This is an interventional prevention trial for Cystic Fibrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cleveland ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Clinical Tool (Mobile Spirometry and Survey)

Arm Description

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.

Outcomes

Primary Outcome Measures

Lung Allocation Score (LAS)

Change in LAS value at the first clinic visit triggered by the clinical tool

Secondary Outcome Measures

Time to transplant

Measured in days (time spent on the lung transplant waiting list)

Survival to transplant

Binary outcome measure to indicate if individual survived to transplant

Full Information

NCT ID

NCT04687475

First Posted

December 17, 2020

Last Updated

August 10, 2023

Sponsor

The Cleveland Clinic

1. Study Identification

Unique Protocol Identification Number

NCT04687475

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 20, 2020 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis, Lung Transplant; Complications

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Clinical Tool (Mobile Spirometry and Survey)

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Clinical Tool (Mobile Spirometry and Survey)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Lung Allocation Score (LAS)

Description

Change in LAS value at the first clinic visit triggered by the clinical tool

Time Frame

Through study completion, an average of 3-6 months (time spent on the lung transplant waiting list).

Secondary Outcome Measure Information:

Title

Time to transplant

Description

Measured in days (time spent on the lung transplant waiting list)

Time Frame

Through study completion, up to 1 year

Title

Survival to transplant

Description

Binary outcome measure to indicate if individual survived to transplant

Time Frame

Through study completion, up to 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Carli J Lehr, MD, MS

Phone

216-444-0962

lehrc@ccf.org

First Name & Middle Initial & Last Name or Official Title & Degree

David Weaver, BSN

Phone

216-445-6671

WEAVERD@ccf.org

Facility Information:

Facility Name

Cleveland Clinic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Individual Site Status

Recruiting

Facility Contact: