Cystic FibrosisOUTREACHNCT05285410
Observational Study Comparing Home to Office Spirometry
An observational study of Cystic Fibrosis, run by Chris Goss at 19 sites in United States.
Trial summary
This is a prospective, longitudinal multicenter observational study comparing home to office spirometry and home to office weight and height measurements. The aim of the study is to estimate the accuracy and variability of home spirometric measurements over time, and to assess the feasibility and acceptability of home… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 116 participants
- Where
- 19 sitesUnited States
- Study dates
- 30 Nov 2022to 19 Dec 2023
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study participants will be recruited at Cystic Fibrosis Foundation's Therapeutics Development Network study sites
Who may be able to join
- Documentation of a CF diagnosis
- Clinically stable
- ≥6 years of age at Screening Visit
- During the run-in period, performed acceptable home spirometry at least twice without virtually coaching and once with virtually coaching
Who cannot join
- History of lung transplantation
- Initiation of a highly effective modulator therapy within 2 months before Screening Visit
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
Providence Alaska Medical Center
Anchorage, Alaska, 99508
The Adult Cystic Fibrosis Center of Central Texas
Austin, Texas, 78705
Boston Children's Hospital
Boston, Massachusetts, 02115
University of South Carolina School of Medicine
Columbia, South Carolina, 29203
Wayne State University Harper University Hospital
Detroit, Michigan, 48201
Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49546
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Lenox Hill Hospital Cystic Fibrosis Center
New York, New York, 10003
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Oregon Health Sciences University
Portland, Oregon, 97239
Seattle Children's Hospital
Seattle, Washington, 98105
Sanford USD Medical Center
Sioux Falls, South Dakota, 57117
Providence Medical Group, Cystic Fibrosis Clinic - Pediatrics
Spokane, Washington, 99204
St. Louis Children's Hospital
St Louis, Missouri, 63110
Toledo Children's Hospital
Toledo, Ohio, 43606
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27103
About this study
Official title: Observational Study of Telehealth for Remote Endpoint Assessment (OUTREACH)
This is a prospective, longitudinal multicenter observational study comparing home to office spirometry and home to office weight and height measurements. The aim of the study is to estimate the accuracy and variability of home spirometric measurements over time, and to assess the feasibility and acceptability of home measurements.
Read the detailed description
After successful completion of the run-in period, participants will have 3 in-person visits, at which office spirometry will be performed and weight and height measured. Participants will perform home spirometry weekly during the study period. They will also electronically complete a weekly electronic patient reported outcome (ePRO) Within one week of each in-person visit, they will measure height and weight at home and perform home spirometry with virtual coaching by site research staff. They will complete a brief ePRO every 4 weeks regarding acceptability and feasibility of home spirometry in research. Within two weeks after study completion, a purposive subsample will complete an exit interview.
- Conditions
- Cystic Fibrosis
- Keywords
- Telehealth, Spirometry, Cystic Fibrosis, CF, Telemedicine, ZEPHYRx
- Medical subject headings
- Cystic Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference (bias) in home spirometry compared to office spirometry for 12-week forced expiratory volume in 1 second (FEV1) (% predicted) change
Difference between home and office spirometry estimates of FEV1 (% predicted) change from Week 0 to Week 12 (home estimate - office estimate)
Measured: Week 0 to Week 12
Analytic efficiency of home versus office spirometry for 12-week FEV1 (% predicted) change
Factor by which trial sample size must increase/decrease to maintain a given power going from office to home spirometry
Measured: Week 0 to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start30 Nov 2022
- Primary completion19 Dec 2023
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- 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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chris Goss
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, University of Arkansas, Harvard University, Cystic Fibrosis Foundation
- Responsible party
- Sponsor-investigator, Chris Goss, Seattle Children's Hospital
- Investigators
- Margaret Rosenfeld, MD, MPH, Principal investigator, University of Washington, Seattle Children's Research InstituteAriel Berlinski, MD, Principal investigator, University of Arkansas for Med. Sciences, Arkansas Children's HospitalAndrea Hartzler, PhD, Principal investigator, University of WashingtonGreg Sawicki, MD, MPH, Principal investigator, Harvard University and Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285410
- Sponsor's protocol ID
- OUTREACH-OB-22
- Acronym
- OUTREACH
- Status last verified
- Jan 2024
- First submitted
- 9 Mar 2022
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Telehealth for Remote Endpoint Assessment (OUTREACH)
- ClinicalTrials.gov ID
- NCT05285410
- Acronym / sponsor ID
- OUTREACH / OUTREACH-OB-22
- Conditions
- Cystic Fibrosis
- Keywords
- Telehealth, Spirometry, Cystic Fibrosis, CF, Telemedicine, ZEPHYRx
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Chris GossUniversity, hospital or other
- Collaborators
- University of Washington, University of Arkansas, Harvard University, Cystic Fibrosis Foundation
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 17 Mar 2022 (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.
This is a prospective, longitudinal multicenter observational study comparing home to office spirometry and home to office weight and height measurements. The aim of the study is to estimate the accuracy and variability of home spirometric measurements over time, and to assess the feasibility and acceptability of home measurements.
Detailed description
After successful completion of the run-in period, participants will have 3 in-person visits, at which office spirometry will be performed and weight and height measured. Participants will perform home spirometry weekly during the study period. They will also electronically complete a weekly electronic patient reported outcome (ePRO) Within one week of each in-person visit, they will measure height and weight at home and perform home spirometry with virtual coaching by site research staff. They will complete a brief ePRO every 4 weeks regarding acceptability and feasibility of home spirometry in research. Within two weeks after study completion, a purposive subsample will complete an exit interview.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study participants will be recruited at Cystic Fibrosis Foundation's Therapeutics Development Network study sites
Key inclusion criteria (4 listed)
- Documentation of a CF diagnosis
- Clinically stable
- ≥6 years of age at Screening Visit
- During the run-in period, performed acceptable home spirometry at least twice without virtually coaching and once with virtually coaching
Key exclusion criteria (2 listed)
- History of lung transplantation
- Initiation of a highly effective modulator therapy within 2 months before Screening Visit
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
Difference (bias) in home spirometry compared to office spirometry for 12-week forced expiratory volume in 1 second (FEV1) (% predicted) change
Time frame: Week 0 to Week 12
Difference between home and office spirometry estimates of FEV1 (% predicted) change from Week 0 to Week 12 (home estimate - office estimate)
Analytic efficiency of home versus office spirometry for 12-week FEV1 (% predicted) change
Time frame: Week 0 to Week 12
Factor by which trial sample size must increase/decrease to maintain a given power going from office to home spirometry
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 11 Jan 2024.
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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.
Margaret Rosenfeld, MD, MPH principal investigator
University of Washington, Seattle Children's Research Institute
Ariel Berlinski, MD principal investigator
University of Arkansas for Med. Sciences, Arkansas Children's Hospital
Andrea Hartzler, PhD principal investigator
University of Washington
19 sites 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 Chris Goss at 19 sites 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 4 inclusion and 2 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 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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?
Difference (bias) in home spirometry compared to office spirometry for 12-week forced expiratory volume in 1 second (FEV1) (% predicted) change (time frame: Week 0 to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2024.