title: Patient-centered physical activity coaching in COPD (Walk On!): A study protocol for a pragmatic randomized controlled trial.
abstract: BACKGROUND
  Physical inactivity is significantly associated with more frequent hospitalizations and increased mortality in COPD even after adjusting for disease severity. While practice guidelines recommend regular physical activity for all patients with COPD, health systems are challenged in operationalizing an effective and sustainable approach to assist patients in being physically active.
  
  
  METHODS
  A pragmatic randomized controlled trial design was used to determine the effectiveness of a 12-month home and community-based physical activity coaching intervention (Walk On!) compared to standard care for 1650 patients at high risk for COPD exacerbations from a large integrated health care system. Eligible patients with a COPD-related hospitalization, emergency department visit, or observational stay in the previous 12months were automatically identified from the electronic medical records (EMR) system and randomized to treatment arms. The Walk On! intervention included collaborative monitoring of step counts, semi-automated step goal recommendations, individualized reinforcement from a physical activity coach, and peer/family support.
  
  
  RESULTS
  The primary composite outcome included all-cause hospitalizations, emergency department visits, observational stays, and death in the 12months following randomization. Secondary outcomes included COPD-related utilization, cardio-metabolic markers, physical activity, symptoms, and health-related quality of life. With the exception of patient reported outcomes, all utilization and clinical variables were automatically captured from the EMR.
  
  
  CONCLUSIONS
  If successful, findings from this multi-stakeholder driven trial of a generalizable and scalable physical activity intervention, carefully designed with sufficient flexibility, intensity, and support for a large ethnically diverse sample could re-define the standard of care to effectively address physical inactivity in COPD.
authors.affiliation: Department of Research & Evaluation, Kaiser Permanente Southern California, United States. Electronic address: huong.q2.nguyen@kp.org.
authors.forename: Huong Q
authors.initials: HQ
authors.lastname: Nguyen
authors.affiliation: Patient Advisory Board Member, United States.
authors.forename: Adrienne
authors.initials: A
authors.lastname: Bailey
authors.affiliation: Department of Research & Evaluation, Kaiser Permanente Southern California, United States.
authors.forename: Karen J
authors.initials: KJ
authors.lastname: Coleman
authors.affiliation: Kaiser Permanente Southern California, San Diego, United States.
authors.forename: Smita
authors.initials: S
authors.lastname: Desai
authors.affiliation: University of Washington, Seattle, United States.
authors.forename: Vincent S
authors.initials: VS
authors.lastname: Fan
authors.affiliation: Department of Research & Evaluation, Kaiser Permanente Southern California, United States.
authors.forename: Michael K
authors.initials: MK
authors.lastname: Gould
authors.affiliation: Department of Research & Evaluation, Kaiser Permanente Southern California, United States.
authors.forename: Leah
authors.initials: L
authors.lastname: Maddock
authors.affiliation: Department of Research & Evaluation, Kaiser Permanente Southern California, United States.
authors.forename: Kimberly
authors.initials: K
authors.lastname: Miller
authors.affiliation: Department of Research & Evaluation, Kaiser Permanente Southern California, United States.
authors.forename: William
authors.initials: W
authors.lastname: Towner
authors.affiliation: Department of Research & Evaluation, Kaiser Permanente Southern California, United States.
authors.forename: Anny H
authors.initials: AH
authors.lastname: Xiang
authors.affiliation: Harvard Medical School, VA Boston Healthcare System, Pulmonary and Critical Care Section, United States.
authors.forename: Marilyn L
authors.initials: ML
authors.lastname: Moy
mesh_terms: D000368:Aged; D015992:Body Mass Index; D018450:Disease Progression; D004636:Emergency Service, Hospital / Q000706:statistics & numerical data*; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D009042:Motivation; D009043:Motor Activity; D010353:Patient Education as Topic; D018802:Patient-Centered Care / Q000379:methods*; D029424:Pulmonary Disease, Chronic Obstructive / Q000378:metabolism / Q000401:mortality / Q000534:rehabilitation*; D011788:Quality of Life; D020377:Self Efficacy; D012944:Social Support; D013147:Spirometry; D016896:Treatment Outcome; D016138:Walking
keywords: COPD; Death; Hospitalizations; Physical activity; Pragmatic design