Chronic obstructive pulmonary disease self-management activation research trial (COPD-SMART): results of recruitment and baseline patient characteristics

Contemp Clin Trials. 2015 Mar:41:192-201. doi: 10.1016/j.cct.2015.01.018. Epub 2015 Feb 3.

Abstract

Objective: To describe the recruitment methods, study participation rate, and baseline characteristics of a representative sample of outpatients with COPD eligible for pulmonary rehabilitation participating in a trial of a lifestyle behavioral intervention to increase physical activity.

Setting and design: A patient registry was developed for recruitment using an administrative database from primary care and specialty clinics of an academic medical center in northeast Texas for a parallel group randomized trial.

Results: The registry was comprised of 5582 patients and over the course of the 30 month recruitment period 325 patients were enrolled for an overall study participation rate of 35.1%. After a 6-week COPD self-management education period provided to all enrolled patients, 305 patients were randomized into either usual care (UC; n=156) or the physical activity self-management intervention (PASM; n=149). There were no clinically significant differences in demographics, clinical characteristics, or health status indicators between the randomized groups.

Conclusion: The results of this recruitment process demonstrate the successful use of a patient registry for enrolling a representative sample of outpatients eligible for pulmonary rehabilitation with COPD from primary and specialty care. Moreover, this approach to patient recruitment provides a model for future studies utilizing administrative databases and electronic health records.

Keywords: Chronic obstructive pulmonary disease; Physical activity; Randomized clinical trial; Recruitment; Self-management.

Publication types

  • Pragmatic Clinical Trial
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Aged
  • Alcohol Drinking / epidemiology
  • Bronchodilator Agents / therapeutic use
  • Comorbidity
  • Depression / epidemiology
  • Female
  • Humans
  • Male
  • Middle Aged
  • Motor Activity*
  • Patient Participation
  • Patient Selection*
  • Pulmonary Disease, Chronic Obstructive / drug therapy
  • Pulmonary Disease, Chronic Obstructive / epidemiology
  • Pulmonary Disease, Chronic Obstructive / rehabilitation*
  • Registries*
  • Self Care / methods*
  • Smoking / epidemiology
  • Texas / epidemiology

Substances

  • Bronchodilator Agents