Walk On! Physical Activity Coaching

Overview

Chronic obstructive pulmonary disease (COPD) is the third leading cause of the death in the US. The personal, social and economic costs of the disease are tremendous, with annual expenditures of nearly $50 billion, mostly from hospitalizations for exacerbations of COPD and associated sequelae. For the vast majority of patients, despite optimal pharmacological therapy, living with COPD is characterized by unrelieved dyspnea, physical inactivity, deconditioning, and an insidious downward spiral of social isolation and depression that has a profound impact on the lives of patients and their caregivers. There is mounting evidence that 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. The investigators propose a pragmatic randomized controlled trial to determine the effectiveness of a 12-month physical activity coaching intervention (Walk On!) compared to standard care for 1,650 COPD patients from a large integrated health care system.

Full Title of Study: “Patient-Centered Physical Activity Coaching in COPD: A Pragmatic Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: August 2018

Detailed Description

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. A pragmatic randomized controlled trial design will be used to determine the effectiveness of a 12-month home and community-based physical activity coaching intervention (Walk On!) compared to standard care for 2,700 COPD patients from a large integrated health care system. Eligible patients with a COPD-related hospitalization, emergency department visit, or observational stay in the previous 12 months will be automatically identified from the electronic medical records (EMR) system and randomized to treatment arms. The Walk On! intervention includes collaborative monitoring of step counts, semi-automated step goal recommendations, individualized reinforcement from a physical activity coach, and peer/family support. The primary composite outcome includes all-cause hospitalizations, emergency department visits, observational stays, and death in the 12 months following randomization. Secondary outcomes include 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 will be automatically captured from the EMR. If successful, findings from this multi-stakeholder driven trial of a generalizable and scalable physical activity intervention model, carefully designed with sufficient flexibility, intensity, duration, and support for a large ethnically diverse sample could re-define the standard of care to effectively address physical inactivity in COPD.

Interventions

  • Behavioral: Physical Activity Coaching (Walk On!)
    • The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.

Arms, Groups and Cohorts

  • No Intervention: Standard Care
    • Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan
  • Experimental: Physical Activity Coaching (Walk On!)
    • The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With All-cause Hospitalizations, Emergency Department (ED) Visits, Observation Stays, and Deaths
    • Time Frame: 12 months following randomization
    • Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site

Secondary Measures

  • Number of Deaths Among Participants
    • Time Frame: 12 months following randomization
    • Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site
  • Number of Participants With All-cause Hospitalizations
    • Time Frame: 12 months following randomization
    • Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site
  • Number of Participants With All-cause Emergency Department Visits
    • Time Frame: 12 months following randomization
    • Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site
  • Number of Participants With All-cause Observation Stays
    • Time Frame: 12 months following randomization
    • Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site
  • Number of Participants With COPD-Related Hospitalizations, ED Visits, and Observation Stays
    • Time Frame: 12 months following randomization
    • Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site
  • Number of Participants With COPD Exacerbation
    • Time Frame: 12 months following randomization
    • COPD exacerbations were ascertained via pharmacy records and utilization data. An outpatient COPD exacerbation will be defined as a care touch (clinic visit, phone, or secure message encounter) with a diagnosis of COPD accompanied by a prescription of either an oral steroid or an antibiotic within 2 days
  • COPD Assessment Test, CAT – 12 Months
    • Time Frame: 12 months
    • The reported mean change between the baseline and 12 Months scores for the Chronic Obstructive Pulmonary Disease Assessment Test (CAT). Score range is 0-40. A negative change score indicates fewer symptoms.
  • Physical Activity
    • Time Frame: 12 months
    • Patients were categorized as being: completely inactive (0 mins/week), insufficiently active (1-149 mins/week) or active, meeting national physical activity recommendations (>150 mins/week) of moderate to vigorous physical activity.
  • Personal Health Questionnaire, PHQ8 – 12 Months
    • Time Frame: 12 months
    • The reported mean change between the baseline and 12 Months scores. Score range is 0-24. A negative change score indicates less depressive symptoms.
  • General Anxiety Disorder, GAD-7 – 12 Months
    • Time Frame: 12 months
    • The reported mean change between the baseline and 12 Months scores. Score range is 0-21. A negative change score indicates less anxiety.
  • PROMIS-10 HRQL , Physical Health – 12 Months
    • Time Frame: 12 months
    • The reported mean change between the baseline and 12 Months T-scores. Score range is 16-68. A positive change score reflects better physical functioning.
  • PROMIS-10 HRQL , Mental Health – 12 Months
    • Time Frame: 12 months
    • The reported mean change between the baseline and 12 Months T-scores. Score range is 21-68. A positive change score reflects better mental health.
  • Diastolic Blood Pressure
    • Time Frame: 12 months following randomization
    • Average of all routine clinic blood pressure reading taken between 6 and 12-months post randomization. BP obtained with temperatures of >100F and those obtained in urgent care were excluded.
  • Systolic Blood Pressure
    • Time Frame: 12 months following randomization
    • Average of all routine clinic blood pressure reading taken between 6 and 12-months post randomization. BP obtained with temperatures of >100F and those obtained in urgent care were excluded.
  • HbA1c Levels
    • Time Frame: 12 months following randomization
    • HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization
  • LDL Levels
    • Time Frame: 12 months following randomization
    • Cholesterol levels were obtained from values closest to the 12 months post randomization
  • HDL Levels
    • Time Frame: 12 months following randomization
    • Cholesterol levels were obtained from values closest to the 12 months post randomization
  • Total Cholesterol Levels
    • Time Frame: 12 months following randomization
    • Cholesterol levels were obtained from values closest to the 12 months post randomization
  • Triglycerides Levels
    • Time Frame: 12 months post randomization
    • Cholesterol levels were obtained from values closest to the 12 months post randomization
  • Body Mass Index
    • Time Frame: 12 months following randomization
    • Body mass index measurements were based on values closest to the 12 months post randomization

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with any COPD-related hospitalization, emergency department visit or observational stay in the previous 12 months are eligible for the study. COPD-related encounters are defined according to the Centers for Medicare and Medicaid Services (CMS) and National Quality Forum (NQF) criteria for the Hospital Readmission Reduction Program. The following principal discharge diagnoses of COPD (ICD-9 codes: 491.21, 491.22, 491.8, 491.9, 492.8, 493.20, 493.21, 493.22, and 496) or respiratory failure (ICD-9 codes: 518.81, 518.82, 518.84, 799.1) with a secondary diagnosis of COPD exacerbation (ICD-9 codes: 491.21, 491.22, 493.21, 493.22) will be used – Age >40 years – On at least a bronchodilator or steroid inhaler prior to the encounter or if not on an inhaler, had a previous COPD diagnosis – Continuous health plan membership in the 12 months prior to the encounter Exclusion Criteria:

  • FEV1/FVC ratio >0.70 at any point in the past year for those with spirometry data – Discharged to hospice, a skilled nursing facility, long term-care or another acute care hospital during the index admission – Level of function at admission or discharge during the index admission is bed bound – Has Alzheimers disease, dementia or metastatic cancer – Morbidly obese (BMI >40) – Completed pulmonary rehabilitation in the last 6 months – Deceased – Dis-enrolled from the health plan

Gender Eligibility: All

Minimum Age: 41 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kaiser Permanente
  • Collaborator
    • Patient-Centered Outcomes Research Institute
  • Provider of Information About this Clinical Study
    • Principal Investigator: Huong Q2 Nguyen, Research Scientist – Kaiser Permanente
  • Overall Official(s)
    • Huong Q Nguyen, PhD, RN, Principal Investigator, Research Scientist

References

Nguyen HQ, Bailey A, Coleman KJ, Desai S, Fan VS, Gould MK, Maddock L, Miller K, Towner W, Xiang AH, Moy ML. Patient-centered physical activity coaching in COPD (Walk On!): A study protocol for a pragmatic randomized controlled trial. Contemp Clin Trials. 2016 Jan;46:18-29. doi: 10.1016/j.cct.2015.10.010. Epub 2015 Oct 24.

Nguyen HQ, Moy ML, Fan VS, Gould MK, Xiang A, Bailey A, Desai S, Coleman KJ. Applying the pragmatic-explanatory continuum indicator summary to the implementation of a physical activity coaching trial in chronic obstructive pulmonary disease. Nurs Outlook. 2018 Sep;66(5):455-463. doi: 10.1016/j.outlook.2018.05.005. Epub 2018 Jul 12.

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