OUTREACH: Observational Study Comparing Home to Office Spirometry

Sponsor

Chris Goss (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05285410

Collaborator

University of Washington (Other), University of Arkansas (Other), Harvard University (Other), Cystic Fibrosis Foundation (Other)

115

Enrollment

Locations

4.3

Anticipated Duration (Months)

5.8

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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 measurements.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis

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

Study Type:

Observational

Anticipated Enrollment :

115 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Observational Study of Telehealth for Remote Endpoint Assessment (OUTREACH)

Anticipated Study Start Date :

Aug 22, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Outcome Measures

Primary Outcome Measures

Difference (bias) in home spirometry compared to office spirometry for 12-week forced expiratory volume in 1 second (FEV1) (% predicted) change [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

History of lung transplantation
Initiation of a highly effective modulator therapy within 2 months before Screening Visit

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Providence Alaska Medical Center	Anchorage	Alaska	United States	99508
2	Arkansas Children's Hospital	Little Rock	Arkansas	United States	72202
3	University of California at Davis Medical Center	Sacramento	California	United States	95817
4	OSF Saint Francis Medical Center	Peoria	Illinois	United States	61637
5	Boston Children's Hospital	Boston	Massachusetts	United States	02115
6	Wayne State University Harper University Hospital	Detroit	Michigan	United States	48201
7	Helen DeVos Children's Hospital	Grand Rapids	Michigan	United States	49546
8	St. Louis Children's Hospital	Saint Louis	Missouri	United States	63110
9	Beth Israel Medical Center	New York	New York	United States	10003
10	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina	United States	27103
11	Children's Hospital Medical Center of Akron	Akron	Ohio	United States	44308
12	Toledo Children's Hospital	Toledo	Ohio	United States	43606
13	Oregon Health Sciences University	Portland	Oregon	United States	97239
14	Jefferson University Hospital	Philadelphia	Pennsylvania	United States	19107
15	University of South Carolina School of Medicine	Columbia	South Carolina	United States	29203
16	Sanford USD Medical Center	Sioux Falls	South Dakota	United States	57117
17	The Adult Cystic Fibrosis Center of Central Texas	Austin	Texas	United States	78705
18	Seattle Children's Hospital	Seattle	Washington	United States	98105
19	Providence Medical Group, Cystic Fibrosis Clinic - Pediatrics	Spokane	Washington	United States	99204
20	Froedtert & Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

Chris Goss
University of Washington
University of Arkansas
Harvard University
Cystic Fibrosis Foundation

Investigators

Principal Investigator: Margaret Rosenfeld, MD, MPH, University of Washington, Seattle Children's Research Institute
Principal Investigator: Ariel Berlinski, MD, University of Arkansas for Med. Sciences, Arkansas Children's Hospital
Principal Investigator: Andrea Hartzler, PhD, University of Washington
Principal Investigator: Greg Sawicki, MD, MPH, Harvard University and Boston Children's Hospital