COPD Resources, Education, and Activity Designed for You Study

Not Applicable

Recruiting

• Conditions: COPD

• Registration Number: NCT07125053
• Lead Sponsor: Rush University Medical Center

Brief Summary

Although COPD self-management treatment programs are effective in reducing COPD-related hospitalizations and increasing quality of life, there is a limited understanding of 'how and why' they work. The proposed research will use an engineering-inspired study design to identify effective COPD self-management treatment components and guide its 'real world' implementation. The long-term goal of this line of research is to build an optimized COPD self-management program, and scale the program up to reduce the burden of COPD at a population health level.

Detailed Description

The study's overall objective is to test component effects of COPD self-management treatment and select an optimized treatment program, while simultaneously gathering information on factors impacting implementation (i.e., Hybrid Type 1 Effectiveness-Implementation Study).1 The study design is guided by the Multiphase Optimization Strategy (MOST),2 an innovative, engineering-inspired methodological framework for intervention development that uses highly efficient randomized experimentation to assess the performance of treatment components on clinically-relevant outcomes, independently and in combination. The proposed research will achieve the following Specific Aims:

Aim 1. Determine the main and interactive effects of three treatment components (i.e., self-management education, inhaler training, and physical activity) on a) respiratory-related hospitalizations over 12 months (primary outcome), and b) health-related quality of life (secondary outcome) by conducting a 2x2x2 factorial experiment. Program costs associated with delivery of each treatment condition will be measured and mediation analyses will be conducted to further understand the mechanisms of component effects.

Sub-Aim 1a. Examine the interaction of baseline disease severity and comorbid conditions (i.e., cardiovascular disease, lung cancer, sleep apnea, metabolic syndrome) with each treatment component on outcomes, to explore potential differences in treatment response.

Aim 2. Select the optimized treatment program. The investigators will identify the optimized treatment package that produces the best expected outcomes (i.e., reduction in respiratory-related hospitalizations and increased health-related quality of life), while maintaining efficiency in the program cost for treatment delivery.

Aim 3. Develop a set of implementation strategies to increase referrals to the optimized treatment program by conducting a mixed methods process evaluation with healthcare providers (N=10-20) and administrators (N=10-20). Informed by the Consolidated Framework for Implementation Research (CFIR), the investigators will assess the barriers and facilitators impacting the program referral workflow, and use this data to inform selection of implementation strategies to increase referrals.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-09
• Study First Submitted QC: 2025-08-09
• Last Update Submitted: 2025-08-14
• Study First Posted: 2025-08-15
• Study Start: 2025-08-18
• Last Update Posted: 2025-08-19
• Primary Completion: 2029-09-01
• Study Completion: 2029-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 448

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
12-month respiratory-related hospitalization	12 months	Incidence of one or more respiratory-related hospitalization at 12-month follow-up

Secondary Outcome Measures

Name	Time	Method
Health-related quality of life	12 weeks	Change in Chronic Respiratory Disease Questionnaire (CRQ)-Mastery subscale score from baseline to 12-week follow-up. A mean score will be computed for the CRQ-Mastery subscale (range 1-7), with higher scores indicating a better outcome.

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States