COPD Resources, Education, and Activity Designed for You Study
COPD READY
Optimizing Effectiveness and Implementation of COPD Self-Management Treatment
2 other identifiers
interventional
448
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2025
CompletedFirst Posted
Study publicly available on registry
August 15, 2025
CompletedStudy Start
First participant enrolled
August 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2029
September 22, 2025
September 1, 2025
4 years
August 9, 2025
September 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
12-month respiratory-related hospitalization
Incidence of one or more respiratory-related hospitalization at 12-month follow-up
12 months
Secondary Outcomes (1)
Health-related quality of life
12 weeks
Study Arms (8)
Condition #1
EXPERIMENTALEducation = self-guided; Physical Activity = on; Inhaler Training = on
Condition #2
EXPERIMENTALEducation = self-guided; Physical Activity = on; Inhaler Training = off
Condition #3
EXPERIMENTALEducation = self-guided; Physical Activity = off; Inhaler Training = on
Condition #4
EXPERIMENTALEducation = self-guided; Physical Activity = off; Inhaler Training = off
Condition #5
EXPERIMENTALEducation = counselor-led; Physical Activity = on; Inhaler Training = on
Condition #6
EXPERIMENTALEducation = counselor-led; Physical Activity = on; Inhaler Training = off
Condition #7
EXPERIMENTALEducation = counselor-led; Physical Activity = off; Inhaler Training = on
Condition #8
EXPERIMENTALEducation = counselor-led; Physical Activity = off; Inhaler Training = off
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rush University Medical Centerlead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- University of Chicagocollaborator
- American Lung Associationcollaborator
Study Sites (1)
Rush University Medical Center
Chicago, Illinois, 60612, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amanda R. Mathew, PhD
Rush University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2025
First Posted
August 15, 2025
Study Start
August 18, 2025
Primary Completion (Estimated)
September 1, 2029
Study Completion (Estimated)
September 1, 2029
Last Updated
September 22, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be made available as soon as possible after the data collection period has ended and will occur no later than the end of the project period or the time of any publication after the study investigators have had reasonable time to prepare manuscripts. Data will remain available for a period of at least 10 years. (i.e., 9/1/29-9/1/39).
- Access Criteria
- Access to the data generated through this project will be granted upon review of a brief request form, completed by the requesting party, that summarizes the intended use of the data (e.g., the nature of any planned analyses), their qualifications, their institutional affiliation, and any required regulatory approval for the planned work by their IRB or other regulatory body. Data sharing will conform to any restrictions specified by regulatory bodies, such as IRBs and institutional Privacy Offices. A Data Use Agreement may be required, depending on the nature of the data requested, at the discretion of our institution's IRB, Office of Legal Affairs, or Privacy Office. Our plan is to deposit research data in the Open Science Framework data archive, an established, publicly accessible repository with a multitude of advantageous features.
Demographics, social determinants of health, clinical trial results, medical records, audio recordings, and survey/ questionnaire data will be collected from a total of 448 adult participants in a nationwide study. Our intent is to share research data to the greatest extent possible, and there are only a few considerations that require us to limit the type and amount of data shared. Given the potential to deduce participant identities from a combination of geographic location and demographic factors, we will not be share geographic data (e.g., Census tract identifiers) or any data extracted from publicly available databases based on participant's residential address. Any intellectual property resulting from this study that can be patented will remain easily and widely available to the researchers in accordance with the NIH Principles and Guidelines. Distribution of resources to for-profit entities may occur under material transfer agreements or non-exclusive license arrangements.