Patient Outcomes of Clinic Transition From Face to Face Encounter to Telemedicine in Cystic Fibrosis

November 28, 2023 updated by: Dana Albon, MD, University of Virginia

Impact on Patient Outcomes of Clinic Transition From Face to Face Encounters to Telemedicine in the Cystic Fibrosis (CF) Adult Population at UVA

Adult patients with Cystic Fibrosis who are seen at the specialty CF clinic at University of Virginia will be given an option to utilize telemedicine instead of in-person visits for standard clinic visits. Health information from standard of care visits including FEV1, exacerbations, leading to oral or intravenous antibiotics, laboratory results, hospitalization records, and responses to health questionnaires will be recorded for research purposes. Data collected for the research study will be compared to baseline and previous years to determine if there are any deleterious effects for those who transition to telemedicine clinic visits.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult CF patients 18 yo and older.

Description

Inclusion Criteria:

  • Adult patients (18-year-old and older) with CF seen in the UVA adult CF clinic who agree to participate in the study.

Exclusion Criteria:

  • Patients who cannot consent to the research study. In addition, prisoners will not be included.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Standard of Care Telemedicine Cohort
This cohort will have telemedicine visits in lieu of in-person clinic visits
Standard of Care In-Person Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FEV1 stability
Time Frame: 12 months
A change of 10% or more in FEV1 percent predicted will be considered significant; FEV1 pre and pos covid telemedicine implementation will be compared
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exacerbation rate
Time Frame: 12 months
Exacerbation rate pre and pos covid telemedicine implementation will be compared
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Dana Albon, MD, University of Virginia Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

May 20, 2020

First Submitted That Met QC Criteria

May 20, 2020

First Posted (Actual)

May 27, 2020

Study Record Updates

Last Update Posted (Actual)

December 5, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22327

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cystic Fibrosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe