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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04402801
• Other study ID #: 22327
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: November 2023
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Locations

Country	Name	City	State
United States	University of Virginia Health System	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (1)

Somerville LAL, List RP, Compton MH, Bruschwein HM, Jennings D, Jones MK, Murray RK, Starheim ER, Webb KM, Gettle LS, Albon DP. Real-World Outcomes in Cystic Fibrosis Telemedicine Clinical Care in a Time of a Global Pandemic. Chest. 2022 May;161(5):1167-1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1 stability	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	Exacerbation rate	Exacerbation rate pre and pos covid telemedicine implementation will be compared	12 months