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COPD Resources, Education, and Activity Designed for You Study

Optimizing Effectiveness and Implementation of COPD Self-Management Treatment

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07125053
Acronym
COPD READY
Enrollment
448
Registered
2025-08-15
Start date
2025-08-18
Completion date
2029-09-01
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

copd, emphysema, chronic bronchitis, self-management, lifestyle management, physical activity, inhaler use, patient education

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.

Interventions

BEHAVIORALEducation (self-guided)

The self-guided eduction program consists of a mailed booklet entitled, Learning to live with COPD, along with two additional mailings with information on the ALA's Patient and Caregiver Network and the Respiratory Health Association's COPD Caregiver's Toolkit.

BEHAVIORALEducation (counselor-led)

The counselor-led education program combines mailings with phone counseling delivered by ALA Lung Helpline counselors. Three phone sessions (20-30 minutes each) are completed over the course of 6 weeks in the main treatment phase, with two additional optional booster sessions offered between 6 and 12-weeks post-randomization. The counselor-led program follows a structured outline of curriculum for each session, focusing on the topic areas of developing a COPD exacerbation action plan, recognizing COPD exacerbations, and coping with breathlessness.

BEHAVIORALPhysical Activity

The physical activity program will consist of a personalized prescription for home-based exercise following published guidelines, consisting of aerobic, strengthening, and flexibility exercises, tailored to participants' current fitness level and dyspnea symptoms. Aerobic exercise will incorporate ground-based walking training, a well-established, safe, and feasible physical activity program for individuals with COPD. Participants will complete three videoconference sessions (30-45 minutes each) over the course of 6 weeks in the main treatment phase, with two additional optional booster sessions between week 6 and 12.

Participants will receive inhaler technique education using a virtual teach-to-goal method. In each session, individuals are observed using their inhaler, provided feedback, and then observed again. Inhaler technique is scored using a checklist specific to each inhaler device. Participants will complete two inhaler training sessions via videoconference at week 1 and week 4, with an optional booster session offered at week 8.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of Chicago
CollaboratorOTHER
American Lung Association
CollaboratorOTHER
Rush University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

2x2x2 factorial study

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
12-month respiratory-related hospitalization12 monthsIncidence of one or more respiratory-related hospitalization at 12-month follow-up

Secondary

MeasureTime frameDescription
Health-related quality of life12 weeksChange 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.

Countries

United States

Contacts

Primary ContactMaritza Esqueda Medina, B.A.
COPD_READY@rush.edu3125633702
Backup ContactAmanda R. Mathew, PhD
COPD_READY@rush.edu3125631273

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026