Personalized COPD education, inhaler training, and activity program
Optimizing Effectiveness and Implementation of COPD Self-Management Treatment
This project will test whether self-management education, inhaler training, and a home-based physical activity program help people with COPD who had a hospital stay in the past year breathe better and avoid future hospitalizations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 448 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Rush University Medical Center Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT07125053 on ClinicalTrials.gov |
What this trial studies
This randomized, engineering-inspired trial uses a 2x2x2 factorial design to test the individual and combined effects of three components: self-management education, inhaler training, and physical activity. The primary outcome is respiratory-related hospitalizations over 12 months, with health-related quality of life as a secondary outcome. The study will also collect program cost data and perform mediation and subgroup analyses to understand how components work and for whom. Findings will be used to select an optimized, scalable COPD self-management program while gathering information on real-world implementation barriers and facilitators.
Who should consider this trial
Good fit: Adults aged 40 or older who live in the continental United States, report a physician diagnosis of COPD and a COPD-related hospitalization in the past 12 months, use inhaled COPD medication at least weekly, and have access to a smartphone, tablet, or computer.
Not a fit: People with a recent COPD exacerbation within the past month, new or worsening unexplained chest pain, inability to perform mild physical activity, cognitive impairment preventing consent, terminal non-COPD illness, residence in chronic care facilities, or inability to read/speak English are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the optimized program could reduce COPD-related hospitalizations and improve quality of life by combining the most effective education, inhaler training, and activity components.
How similar studies have performed: Previous COPD self-management programs have reduced hospitalizations and improved quality of life, but using a factorial MOST design to identify which specific components are most effective is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Residence in the continental United States * Age 40 years or older * Report a physician diagnosis of COPD * Report a COPD-related hospitalization over the past 12 months * Use an inhaled medication for COPD at least once per week * Have access to a connected device (i.e., smartphone, tablet, and/ or computer) to complete study procedures Exclusion Criteria: * COPD exacerbation within the past month * New or worsening chest pain that happens without exertion * Cognitive dysfunction impairing ability to provide informed consent and follow study procedures * Terminal illness (i.e., \< 6 month life expectancy) that is non-COPD related * Living at a chronic care facility (i.e., nursing home, assisted living) * Inability to participate in mild physical activity such as walking, stretching, and lower limb exercises * Inability to speak/ read English
Where this trial is running
Chicago, Illinois
- Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Amanda R. Mathew, PhD — Rush University Medical Center
- Study coordinator: Maritza Esqueda Medina, B.A.
- Email: COPD_READY@rush.edu
- Phone: 3125633702
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.