UnknownNot Applicable

Informatics Framework for Pulmonary Rehabilitation

United States120 participantsStarted 2020-06-11

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of patients who completed the program

Timeframe: 3 months

Trial details

NCT IDNCT03981783

SponsorIcahn School of Medicine at Mount Sinai

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-28

Contact for this trial

Joseph Finkelstein, MD

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

View on ClinicalTrials.gov More COPD trials