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

NeuroTherapia, Inc.

Status: Active, not recruiting

Conditions: Lung Transplant; Complications; Cystic Fibrosis

Treatments: Other: Clinical Tool (Mobile Spirometry and Survey)

Study type: Interventional

Funder types: Other

Identifiers

NCT04687475

19-112

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Clinical Tool (Mobile Spirometry and Survey)

Experimental group

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.

Treatment:

Other: Clinical Tool (Mobile Spirometry and Survey)