Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Chronic obstructive pulmonary disease, Randomized controlled trial, Self-management support, Physical activity
Brief summary
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
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.
Interventions
BEHAVIORALPhysical activity self-management
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.
OTHERCOPD education + Usual care
Six weeks of COPD self-management education plus usual care
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Texas
University of Alabama at Birmingham
The University of Texas Health Science Center at Tyler
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronic Respiratory Disease Questionnaire | 6, 12, and 18 months | Standardized quality-of-life instrument for patients with COPD. |
| 6-minute walk | 6, 12, and 18 months | Standardized walking test to measure functional capacity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness | 18 months | Health care utilization and SF-12 will be used to estimated cost effectiveness of the intervention. |
| Self-reported adverse event reporting | monthly for 18 months | Patients will be asked monthly about adverse events associated with study participation. |
Countries
United States
Outcome results
None listed