title: 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.
authors.affiliation: Baylor Medical Center, Behavioral Health Center, Plano, TX, USA.
authors.forename: Jamile
authors.initials: J
authors.lastname: Ashmore
authors.forename: Rennie
authors.initials: R
authors.lastname: Russo
authors.forename: Jennifer
authors.initials: J
authors.lastname: Peoples
authors.forename: John
authors.initials: J
authors.lastname: Sloan
authors.forename: Bradford E
authors.initials: BE
authors.lastname: Jackson
authors.forename: Sejong
authors.initials: S
authors.lastname: Bae
authors.forename: Karan P
authors.initials: KP
authors.lastname: Singh
authors.forename: Steven N
authors.initials: SN
authors.lastname: Blair
authors.forename: David
authors.initials: D
authors.lastname: Coultas
mesh_terms: D000368:Aged; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000534:rehabilitation*; D040242:Risk Reduction Behavior; D012648:Self Care / Q000379:methods*
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