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

NCT ID: NCT04402801

Last Updated: 2023-12-05

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2022-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cystic Fibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard of Care Telemedicine Cohort

This cohort will have telemedicine visits in lieu of in-person clinic visits

No interventions assigned to this group

Standard of Care In-Person Cohort

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Virginia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dana Albon, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dana Albon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia Health System

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Virginia Health System

Charlottesville, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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):1167-1179. doi: 10.1016/j.chest.2021.11.035. Epub 2021 Dec 10.

Reference Type RESULT
PMID: 34896356 (View on PubMed)

Bruschwein HM, Soper M, Jennings D, Somerville L, List R, Compton MH, Turner R, Albon D. Mental health screening of patients with cystic fibrosis through telehealth during COVID-19: Evaluation of feasibility and process adoption. Fam Syst Health. 2022 Sep;40(3):397-402. doi: 10.1037/fsh0000698. Epub 2022 May 23.

Reference Type DERIVED
PMID: 35604723 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

22327

Identifier Type: -

Identifier Source: org_study_id