Recruiting

CHIEF-PR

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT03981783

Conditions

COPD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Best available care (BAC)

Telerehabilitation (TH)

Study Details

Brief summary:

Previous studies clearly established clinical benefits of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease however uptake and completion rate of pulmonary rehabilitation programs by these patients is limited by multiple barriers. The goal of this project to systematically evaluate impact of Comprehensive Health Informatics Engagement Framework for Pulmonary Rehabilitation (CHIEF-PR) in a randomized controlled trial. The main hypothesis is that CHIEF-PR will result in significantly higher rates of completion of a comprehensive pulmonary rehabilitation program.

Conditions

COPD

Study ID

NCT03981783

Start date

Jun 11, 2020

Status verified date

Oct, 2022

Completion date

Aug 31, 2023

Anticipated

Primary completion date

Feb 28, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 40 years and older at the time of randomization;
  • Have a physician diagnosis of COPD
  • Have moderate to severe COPD according to GOLD classification (Stages II - III)
  • Understand spoken English or Spanish
  • Urgent care event due to COPD within 4 weeks of enrollment
  • Have no other member of the household enrolled in the study

Exclusion Criteria:

  • Evidence that the patient may move from the study area before the completion of the study
  • Impaired cognitive status as indicated by MMSE<24
  • Presence of any health condition, that would preclude participation (e.g., psychiatric diagnosis, unstable cardiovascular condition or physical disability)

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Best available care (BAC)

experimental: Telerehabilitation (TH)

Interventions

Best available care (BAC)

Eligible patients are assigned to a standard pulmonary rehabilitation program

Telerehabilitation (TH)

Eligible patients are assigned to a pulmonary telerehabilitation program

Primary outcome measure

  • Percentage of patients who completed the program [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Joseph Finkelstein, MD

212-659-9596Joseph.Finkelstein@mssm.edu

Locations

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Joseph Finkelstein, MD

212-659-9596Joseph.Finkelstein@mssm.edu

Venus Velez, MBA

212-659-9686Venus.Velez@mssm.edu

Principal Investigator:

Joseph Finkelstein, MD

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Oct 31, 2022

Last verified

Oct, 2022

Keywords

  • COPD
  • Pulmonary Rehabilitation
  • Telerehabilitation
  • Clinical Decision Support
  • Adherence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2022-10-31.