COPDCOPD READYNCT07125053
COPD Resources, Education, and Activity Designed for You Study
A study testing Education (self-guided), Education (counselor-led) and Physical Activity in people with COPD, run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Education (self-guided), Education (counselor-led) and Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2025to 1 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Maritza Esqueda Medina, B.A., 312-563-3702, COPD_READY@rush.edu
Amanda R. Mathew, PhD
About this study
Official title: Optimizing Effectiveness and Implementation of COPD Self-Management Treatment
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.
Read the 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.
- Conditions
- COPD
- Being tested
- Education (self-guided), Education (counselor-led), Physical Activity, Inhaler Training
- Keywords
- copd, emphysema, chronic bronchitis, self-management, lifestyle management, physical activity, inhaler use, patient education
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema, Bronchitis, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education (self-guided)Behavioural
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.
Education (counselor-led)Behavioural
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.
Physical ActivityBehavioural
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.
Inhaler TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Condition #1 | Experimental | Education = self-guided; Physical Activity = on; Inhaler Training = on Receives: Behavioral: Education (self-guided); Behavioral: Physical Activity; Behavioral: Inhaler Training |
| Condition #2 | Experimental | Education = self-guided; Physical Activity = on; Inhaler Training = off Receives: Behavioral: Education (self-guided); Behavioral: Physical Activity |
| Condition #3 | Experimental | Education = self-guided; Physical Activity = off; Inhaler Training = on Receives: Behavioral: Education (self-guided); Behavioral: Inhaler Training |
| Condition #4 | Experimental | Education = self-guided; Physical Activity = off; Inhaler Training = off Receives: Behavioral: Education (self-guided) |
| Condition #5 | Experimental | Education = counselor-led; Physical Activity = on; Inhaler Training = on Receives: Behavioral: Education (counselor-led); Behavioral: Physical Activity; Behavioral: Inhaler Training |
| Condition #6 | Experimental | Education = counselor-led; Physical Activity = on; Inhaler Training = off Receives: Behavioral: Education (counselor-led); Behavioral: Physical Activity |
| Condition #7 | Experimental | Education = counselor-led; Physical Activity = off; Inhaler Training = on Receives: Behavioral: Education (counselor-led); Behavioral: Inhaler Training |
| Condition #8 | Experimental | Education = counselor-led; Physical Activity = off; Inhaler Training = off Receives: Behavioral: Education (counselor-led) |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month respiratory-related hospitalization
Incidence of one or more respiratory-related hospitalization at 12-month follow-up
Measured: 12 months
Secondary outcomes (1)
Health-related quality of life
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start18 Aug 2025
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2x2 factorial study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 448 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Chicago, American Lung Association
- Responsible party
- Sponsor
- Investigators
- Amanda R. Mathew, PhD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125053
- Sponsor's protocol ID
- ORA# 23050802
- Other IDs
- R01HL173120-01A1
- Acronym
- COPD READY
- Status last verified
- Oct 2026
- First submitted
- 9 Aug 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Effectiveness and Implementation of COPD Self-Management Treatment
- ClinicalTrials.gov ID
- NCT07125053
- Acronym / sponsor ID
- COPD READY / ORA# 23050802
- Conditions
- COPD
- Keywords
- copd, emphysema, chronic bronchitis, self-management, lifestyle management, physical activity, inhaler use, patient education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 448 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Chicago, American Lung Association
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- 2x2x2 factorial study
| Arm | Type | Receives |
|---|---|---|
| Condition #1 | Experimental | Behavioral: Education (self-guided), Behavioral: Physical Activity, Behavioral: Inhaler TrainingEducation = self-guided; Physical Activity = on; Inhaler Training = on |
| Condition #2 | Experimental | Behavioral: Education (self-guided), Behavioral: Physical ActivityEducation = self-guided; Physical Activity = on; Inhaler Training = off |
| Condition #3 | Experimental | Behavioral: Education (self-guided), Behavioral: Inhaler TrainingEducation = self-guided; Physical Activity = off; Inhaler Training = on |
| Condition #4 | Experimental | Behavioral: Education (self-guided)Education = self-guided; Physical Activity = off; Inhaler Training = off |
| Condition #5 | Experimental | Behavioral: Education (counselor-led), Behavioral: Physical Activity, Behavioral: Inhaler TrainingEducation = counselor-led; Physical Activity = on; Inhaler Training = on |
| Condition #6 | Experimental | Behavioral: Education (counselor-led), Behavioral: Physical ActivityEducation = counselor-led; Physical Activity = on; Inhaler Training = off |
| Condition #7 | Experimental | Behavioral: Education (counselor-led), Behavioral: Inhaler TrainingEducation = counselor-led; Physical Activity = off; Inhaler Training = on |
| Condition #8 | Experimental | Behavioral: Education (counselor-led)Education = counselor-led; Physical Activity = off; Inhaler Training = off |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Condition #1, Condition #2, Condition #3, Condition #4 |
| 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. | Behavioural | Condition #5, Condition #6, Condition #7, Condition #8 |
| Physical ActivityThe 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. | Behavioural | Condition #1, Condition #2, Condition #5, Condition #6 |
| Inhaler TrainingParticipants 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. | Behavioural | Condition #1, Condition #3, Condition #5, Condition #7 |
Primary outcome
12-month respiratory-related hospitalization
Time frame: 12 months
Incidence of one or more respiratory-related hospitalization at 12-month follow-up
1 secondary outcome
Health-related quality of life
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amanda R. Mathew, PhD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education (self-guided), Education (counselor-led) and Physical Activity in people with COPD, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maritza Esqueda Medina, B.A. (3125633702, COPD_READY@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-month respiratory-related hospitalization (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.