Randomized Trial of Physical Activity Self-Management Intervention for Patients With COPD

Study Overview
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Brief Summary
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Chronic obstructive pulmonary disease (COPD) is a common condition associated with major disability. There is strong evidence that pulmonary rehabilitation (PR) improves outcomes and is cost saving, but fewer than 2% of patients have access to these programs. New methods of PR are needed to increase access of patients with COPD to these established benefits. To address this gap we propose a novel physical activity self-management (PASM) program based on an evidence-based physical activity intervention designed to increase physical activity and quality of life. Key components of the program include tailored telephone counseling, a workbook, and computer-assisted telephone follow-up. We will test the following two hypotheses: 1) Patients with COPD who receive PASM have clinically and statistically significant improvements in functional performance (i.e., Chronic Respiratory Questionnaire [CRQ] dyspnea domain and 6-minute walk) compared to patients who receive UC. 2) The PASM program is more cost-effective compared to the UC. The project addresses a major gap in the current management of COPD and may provide a novel, cost-effective strategy for improving functional performance and health status.

Detailed Description
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Chronic obstructive pulmonary disease (COPD) has been targeted nationally as a priority condition for which multiple strategies are needed to improve outcomes. The absolute number of years lost to disability due to COPD exceeds the years of life lost due to premature death. There is strong evidence that pulmonary rehabilitation (PR) improves outcomes and is cost saving, but fewer than 2% of patients have access to these programs. New methods of PR are needed to increase access of patients with COPD to these established benefits. To address this gap we propose a novel physical activity self-management (PASM) program based on an evidence-based physical activity intervention designed to increase physical activity and quality of life. Key components of the program include tailored telephone counseling, a workbook, and computer-assisted telephone follow-up. Our specific aims are: 1) To implement a PASM program for patients with COPD. 2) To conduct an 18-month, randomized, controlled, single-blind trial comparing PASM (n=150) to usual care (UC) (n=150) to determine the effectiveness on functional performance and health status. 3) To determine the cost-effectiveness of the intervention. Follow-up data will be collected at 6, 12, and 18 months after start of the intervention. We will test the following two hypotheses: 1) Patients with COPD who receive PASM have clinically and statistically significant improvements in functional performance (i.e., Chronic Respiratory Questionnaire [CRQ] dyspnea domain and 6-minute walk) compared to patients who receive UC. 2) The PASM program is more cost-effective compared to the UC. The project addresses a major gap in the current management of COPD and may provide a novel, cost-effective strategy for improving functional performance and health status.

Official Title
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Randomized Trial of Physical Activity Self-Management Intervention for Patients With COPD

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Behavioral: Physical activity self-management
* Other: COPD education + Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A physician diagnosis of COPD Age 45 years and older Affirmative response to Are you short of breath when hurrying on the level or walking up a slight hill? Post-bronchodilator FEV1/FVC <0.7 and FEV1 <70% Exclusion Criteria: Inability to speak/read English Lives in a chronic care facility (i.e., nursing home, assisted living) Plans to move from the area within the next 18 months Life expectancy less than 12 months Participation in pulmonary rehabilitation or other clinical research in the past 12 months Inability to walk without assistance of a wheelchair or walker Inability to walk at least 110m on a 6-minute walk Uncontrolled angina, hypertension, psychiatric illness, or dementia Inability to obtain supplemental oxygen if indicated

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: COPD education + Usual care<br>Six weeks of COPD self-management education plus usual care | Other: COPD education + Usual care<br>* Six weeks of COPD self-management education plus usual care<br>|
| Experimental: Physical activity self-management<br>Cognitive behavioral counseling to increase lifestyle physical activity delivered over five months plus six weeks of COPD self-management education and usual care | Behavioral: Physical activity self-management<br>* This intervention includes a manual, telephone health coach calls, and automated telephone calls. The manual has 20 chapters for the active phase and 5 maintenance phase chapters. During the first 20 weeks the health coach will call patients every other week and the automated telephone calls will occur on the alternate weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic Respiratory Disease Questionnaire | Standardized quality-of-life instrument for patients with COPD. | 6, 12, and 18 months | 
| 6-minute walk | Standardized walking test to measure functional capacity. | 6, 12, and 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness | Health care utilization and SF-12 will be used to estimated cost effectiveness of the intervention. | 18 months | 
| Self-reported adverse event reporting | Patients will be asked monthly about adverse events associated with study participation. | monthly for 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic obstructive pulmonary disease, Randomized controlled trial, Self-management support, Physical activity