An interventional study of Education (self-guided) and Education (counselor-led) in COPD, sponsored by Rush University Medical Center. Recruiting at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Rush University Medical Center · Not applicable, Interventional, and 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.
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.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 448 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Rush University Medical Center is the lead sponsor of 397 studies on the registry; 61 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Education = self-guided; Physical Activity = on; Inhaler Training = on
Behavioral: Education (self-guided) · Behavioral: Physical Activity · Behavioral: Inhaler Training
Education = self-guided; Physical Activity = on; Inhaler Training = off
Behavioral: Education (self-guided) · Behavioral: Physical Activity
Education = self-guided; Physical Activity = off; Inhaler Training = on
Behavioral: Education (self-guided) · Behavioral: Inhaler Training
Education = self-guided; Physical Activity = off; Inhaler Training = off
Behavioral: Education (self-guided)
Education = counselor-led; Physical Activity = on; Inhaler Training = on
Behavioral: Education (counselor-led) · Behavioral: Physical Activity · Behavioral: Inhaler Training
Education = counselor-led; Physical Activity = on; Inhaler Training = off
Behavioral: Education (counselor-led) · Behavioral: Physical Activity
Education = counselor-led; Physical Activity = off; Inhaler Training = on
Behavioral: Education (counselor-led) · Behavioral: Inhaler Training
Education = counselor-led; Physical Activity = off; Inhaler Training = off
Behavioral: Education (counselor-led)
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.
12-month respiratory-related hospitalization
Incidence of one or more respiratory-related hospitalization at 12-month follow-up
Time frame: 12 months
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.
Time frame: 12 weeks
Plan to share: 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.
Supporting information: 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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