Observational Study Comparing Home to Office Spirometry (OUTREACH)

January 10, 2024 updated by: Chris Goss

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

116

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Providence Alaska Medical Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital
    • Illinois
      • Peoria, Illinois, United States, 61637
        • OSF Saint Francis Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University Harper University Hospital
      • Grand Rapids, Michigan, United States, 49546
        • Helen DeVos Children's Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • St. Louis Children's Hospital
    • New York
      • New York, New York, United States, 10003
        • Lenox Hill Hospital Cystic Fibrosis Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Wake Forest University Baptist Medical Center
    • Ohio
      • Akron, Ohio, United States, 44308
        • Children's Hospital Medical Center of Akron
      • Toledo, Ohio, United States, 43606
        • Toledo Children's Hospital
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health Sciences University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Jefferson University Hospital
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • University of South Carolina School of Medicine
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117
        • Sanford USD Medical Center
    • Texas
      • Austin, Texas, United States, 78705
        • The Adult Cystic Fibrosis Center of Central Texas
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital
      • Spokane, Washington, United States, 99204
        • Providence Medical Group, Cystic Fibrosis Clinic - Pediatrics
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert & Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study participants will be recruited at Cystic Fibrosis Foundation's Therapeutics Development Network study sites

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Week 0 to Week 12
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
Week 0 to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chris Goss

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2022

Primary Completion (Actual)

December 19, 2023

Study Completion (Actual)

December 19, 2023

Study Registration Dates

First Submitted

March 9, 2022

First Submitted That Met QC Criteria

March 9, 2022

First Posted (Actual)

March 17, 2022

Study Record Updates

Last Update Posted (Actual)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OUTREACH-OB-22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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