Self-Management Programs for COPD

(COPD READY Trial)

Overseen By Amanda R. Mathew, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Must be taking: Inhaled medications

Disqualifiers: Recent COPD exacerbation, Cognitive dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

448 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve understanding of how self-management programs help people with COPD (a lung disease that makes breathing difficult) reduce hospital visits and enhance their quality of life. It tests various combinations of self-guided or counselor-led education, inhaler training, and physical activity to identify the most effective approach. Suitable participants have been diagnosed with COPD, hospitalized for it in the past year, and use inhaled medication weekly. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance COPD management and improve patient outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since participants must use an inhaled medication for COPD at least once per week, it seems likely that you can continue your current COPD medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that self-management programs for COPD, which include education, inhaler training, and physical activity, are generally safe for individuals. Research indicates that self-guided education does not increase hospital or emergency room visits and is considered manageable and acceptable, with most individuals handling it well. Counselor-led education also does not lead to more hospital visits, and some studies suggest it can improve quality of life. Inhaler training is straightforward and can reduce mistakes in inhaler use, potentially leading to better COPD management. Physical activity is both safe and beneficial, as it can lower hospital visits and improve exercise capacity and lung function. Overall, these components are safe and can enhance health outcomes for those with COPD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these self-management programs for COPD because they offer a personalized approach to managing the condition. Unlike standard treatments that typically focus on medication, these programs incorporate education, inhaler training, and physical activity, empowering patients to take control of their health. The self-guided or counselor-led education provides flexibility and support, while inhaler training ensures effective medication use. Additionally, integrating physical activity can improve overall lung function and quality of life, making these programs a comprehensive alternative to traditional care.

What evidence suggests that this trial's treatments could be effective for COPD?

This trial will evaluate different self-management programs for COPD, including combinations of education, inhaler training, and physical activity. Research has shown that self-management programs can help people with COPD by reducing the need for emergency medication and increasing the use of treatments for breathing problems. In this trial, some participants will receive education led by counselors, which studies indicate often improves understanding of COPD and helps create effective management plans. Others will receive self-guided education. Training on correct inhaler use, another component of this trial, has improved proper use by 28%, enhancing the quality of life for COPD patients. Additionally, regular physical activity, which some participants will engage in, greatly improves exercise ability, muscle strength, and overall quality of life for those with COPD, as supported by various studies. Together, these elements have improved health outcomes and reduced hospital visits related to COPD. ^{3 6 7 8 9}

Who Is on the Research Team?

Amanda R. Mathew, PhD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with Chronic Obstructive Pulmonary Disease (COPD), including conditions like emphysema and chronic bronchitis. Participants should be interested in learning self-management techniques to improve their condition.

Inclusion Criteria

Residence in the continental United States

I am 40 years old or older.

I have been diagnosed with COPD by a doctor.

Exclusion Criteria

I experience new or worsening chest pain without physical activity.

Living at a chronic care facility (i.e., nursing home, assisted living)

Inability to speak/read English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive COPD self-management treatment components including self-management education, inhaler training, and physical activity

12 weeks

Follow-up

Participants are monitored for respiratory-related hospitalizations and health-related quality of life

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Education (counselor-led)
• Education (self-guided)
• Inhaler Training
• Physical Activity

Trial Overview The study tests the effectiveness of different COPD self-management treatments, such as physical activity routines, inhaler training, and both counselor-led and self-guided education programs.

How Is the Trial Designed?

Group I: Condition #8 Experimental Treatment 1 Intervention

Education = counselor-led; Physical Activity = off; Inhaler Training = off

Group II: Condition #7 Experimental Treatment 2 Interventions

Education = counselor-led; Physical Activity = off; Inhaler Training = on

Group III: Condition #6 Experimental Treatment 2 Interventions

Education = counselor-led; Physical Activity = on; Inhaler Training = off

Group IV: Condition #5 Experimental Treatment 3 Interventions

Education = counselor-led; Physical Activity = on; Inhaler Training = on

Group V: Condition #4 Experimental Treatment 1 Intervention

Education = self-guided; Physical Activity = off; Inhaler Training = off

Group VI: Condition #3 Experimental Treatment 2 Interventions

Education = self-guided; Physical Activity = off; Inhaler Training = on

Group VII: Condition #2 Experimental Treatment 2 Interventions

Education = self-guided; Physical Activity = on; Inhaler Training = off

Group VIII: Condition #1 Experimental Treatment 3 Interventions

Education = self-guided; Physical Activity = on; Inhaler Training = on

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

American Lung Association

Collaborator

Trials

32

Recruited

11,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07125053

COPD Resources, Education, and Activity Designed for ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9045592/

Evaluation of a Digital COPD Education Program for ... The intervention was a digital COPD education program accessible for three months. Data was collected through questionnaires on COPD-specific knowledge, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9073270/

Educational interventions for health professionals managing ... Studies have shown beneficial effects of training and education on health professional knowledge and practices surrounding COPD diagnosis and treatment. A four‐ ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S095461111300303X

Educational programmes in COPD management ... In total, 81 articles, describing 67 interventions were included. The majority (53.8%) of the studies incorporated 10 or more educational topics.

5. resmedjournal.com resmedjournal.com/article/S0954-6111(13)00303-X/fulltext

Educational programmes in COPD management ... In total, 81 articles, describing 67 interventions were included. The majority (53.8%) of the studies incorporated 10 or more educational topics.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1746688/

Self-management education for patients with chronic ... Self-management education had no effect on hospital admissions, emergency room visits, days lost from work, and lung function.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/12535447/

Self-management education for chronic obstructive ... The studies showed no effect of self-management education on hospital admissions, emergency room visits, days lost from work and lung function.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31502238/

COPD-Specific Self-Management Support Provided by ... COPD-Specific Self-Management Support Provided by Trained Educators in Everyday Practice Is Associated With Improved Quality of Life, Health-Directed ...

9. mdpi.com mdpi.com/1648-9144/60/3/377

A Chronic Obstructive Pulmonary Disease Self ... The present study aimed to assess the impact of COPD self-management interventions on quality of life, functional status, patient education, depression, and ...