COPD Resources, Education, and Activity Designed for You Study
NCT07125053 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 448
Last updated 2025-09-22
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.
Conditions
Interventions
- BEHAVIORAL
-
Education (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.
- BEHAVIORAL
-
Education (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.
- BEHAVIORAL
-
Physical 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.
- BEHAVIORAL
-
Inhaler Training
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 & Collaborators
-
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH -
University of Chicago
collaborator OTHER -
American Lung Association
collaborator OTHER -
Rush University Medical Center
lead OTHER
Principal Investigators
-
Amanda R. Mathew, PhD · Rush University Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-18
- Primary Completion
- 2029-09-01
- Completion
- 2029-09-01
Countries
- United States
Study Locations
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