Cystic FibrosisNCT04402801
Patient Outcomes of Clinic Transition From Face to Face Encounter to Telemedicine in Cystic Fibrosis
An observational study of Cystic Fibrosis, run by University of Virginia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: Adult CF patients 18 yo and older.
Who may be able to join
- Adult patients (18-year-old and older) with CF seen in the UVA adult CF clinic who agree to participate in the study.
Who cannot join
- Patients who cannot consent to the research study. In addition, prisoners will not be included.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
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
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.
- Conditions
- Cystic Fibrosis
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Telemedicine Cohort | This cohort will have telemedicine visits in lieu of in-person clinic visits | |
| Standard of Care In-Person Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (1)
Exacerbation rate
Exacerbation rate pre and pos covid telemedicine implementation will be compared
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Jun 2020
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dana Albon, MD, University of Virginia
- Investigators
- Dana Albon, MD, Principal investigator, University of Virginia Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402801
- Sponsor's protocol ID
- 22327
- Status last verified
- Nov 2023
- First submitted
- 20 May 2020
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34896356Bruschwein 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.
PubMed 35604723
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04402801
- Acronym / sponsor ID
- 22327
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 27 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Telemedicine Cohort | – | –This cohort will have telemedicine visits in lieu of in-person clinic visits |
| Standard of Care In-Person Cohort | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult CF patients 18 yo and older.
Key inclusion criteria (1 listed)
- Adult patients (18-year-old and older) with CF seen in the UVA adult CF clinic who agree to participate in the study.
Key exclusion criteria (1 listed)
- Patients who cannot consent to the research study. In addition, prisoners will not be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Exacerbation rate
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Results publication: PubMed 34896356Somerville 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.
- Derived from this study: PubMed 35604723Bruschwein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana Albon, MD principal investigator
University of Virginia Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1 stability (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04402801, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.