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

The University of Texas System (UT)

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Behavioral: Physical activity self-management; Other: COPD education + Usual care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01108991

679

R18HL092955-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 325 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

325 participants in 2 patient groups

COPD education + Usual care

Active Comparator group

Description:

Six weeks of COPD self-management education plus usual care

Treatment:

Other: COPD education + Usual care

Physical activity self-management

Experimental group

Description:

Cognitive behavioral counseling to increase lifestyle physical activity delivered over five months plus six weeks of COPD self-management education and usual care

Treatment:

Behavioral: Physical activity self-management