Chronic obstructive pulmonary disease self-management activation research trial (COPD-SMART): design and methods

Abstract

Background: Treatment of COPD requires multiple pharmacological and non-pharmacological intervention strategies. One target is physical inactivity because it leads to disability and contributes to poor physical and mental health. Unfortunately, less than 1% of eligible patients have access to gold-standard pulmonary rehabilitation.

Methods: A single-site parallel group randomized trial was designed to determine if a self-management lifestyle physical activity intervention would improve physical functioning and dyspnea. During the first six weeks after enrollment patients receive COPD self-management education delivered by a health coach using a workbook and weekly telephone calls. Patients are then randomized to usual care or the physical activity intervention. The 20 week physical activity intervention is delivered by the health coach using a workbook supported by alternating one-on-one telephone counseling and computer assisted telephone calls. Theoretical foundations include social cognitive theory and the transtheoretical model.

Results: Primary outcomes include change in Chronic Respiratory Questionnaire (CRQ) dyspnea domain and 6-minute walk distance measured at 6-, 12-, and 18-months after randomization. Secondary outcomes include other CRQ domains (fatigue, emotion, and mastery), SF-12, and health care utilization. Other measures include process outcomes and clinical characteristics.

Conclusions: This theory driven self-management lifestyle physical activity intervention is designed to reach patients unable to complete center-based pulmonary rehabilitation. Results will advance knowledge and methods for dissemination of a potentially cost-effective program for patients with COPD.

Keywords: ALED; Active Living Everyday; BMI; BODE index; Body mass index; CAT; COPD; COPD self-management activation research trial; COPD-SMART; CRQ; Chronic Respiratory Questionnaire; Chronic obstructive pulmonary disease; Computer assisted telephone system; DBC; DCC; Data coordinating center; David B. Coultas; FEV1; FVC; Forced expiratory volume in one second; Forced vital capacity; GDS; GOLD; Geriatric Depression Scale; Global Initiative for Chronic Obstructive Lung Disease; JA; Jamile Ashmore; Lifestyle; MCS; Mental health composite score; PASM; PCS; Physical activity; Physical activity self-management; Physical composite score; Pulmonary rehabilitation; QALY; Quality adjusted life-years; RR; Randomized trial; Rennie Russo; Self-management; UC; UTHSCT; University of Texas Health Science Center-Tyler; Usual care; [B]ody-mass index, degree of airflow [O]bstruction, [D]yspnea level, [E]xercise capacity.

Proposed number and flow of patients with COPD in randomized trial comparing physical activity self-management (PASM) to usual care (UC).