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

NCT ID: NCT04687475

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-20

Study Completion Date

2026-06-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Cystic Fibrosis Lung Transplant; Complications

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Clinical Tool (Mobile Spirometry and Survey)

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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19-112

Identifier Type: -

Identifier Source: org_study_id

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