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Walk On! Physical Activity Coaching

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02478359
First Posted: June 23, 2015
Last Update Posted: August 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Huong Q2 Nguyen, Kaiser Permanente
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease (COPD) Behavioral: Physical Activity Coaching (Walk On!)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Patient-Centered Physical Activity Coaching in COPD: A Pragmatic Trial

Resource links provided by NLM:


Further study details as provided by Huong Q2 Nguyen, Kaiser Permanente:

Primary Outcome Measures:
  • Composite: All-cause hospitalizations, emergency department (ED) visits, observational stays, and mortality [ Time Frame: 12 months following randomization ]

Secondary Outcome Measures:
  • Composite: COPD-related hospitalizations, ED visits, and observational stays [ Time Frame: 12 months following randomization ]
    COPD-related hospitalizations, ED visits, and observational stays will be defined according to the current CMS criteria. 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 (518.81, 518.82, 518.84, 799.1) and a secondary diagnosis of COPD exacerbation (491.21, 491.22, 493.21, 493.22) will be used.

  • COPD exacerbations [ Time Frame: 12 months following randomization ]
    COPD exacerbations will be 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.

  • Physical activity [ Time Frame: 12 months following randomization ]
    Patients will be 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.

  • Body mass index [ Time Frame: 12 months following randomization ]
  • Blood pressure [ Time Frame: 12 months following randomization ]
  • High density lipoprotein (HDL) [ Time Frame: 12 months following randomization ]
  • Low density lipoprotein (LDL) [ Time Frame: 12 months following randomization ]
  • Hemoglobin A1c (HbA1c) [ Time Frame: 12 months following randomization ]
    Only for participants with diabetes

  • Health-Related Quality of life (HRQL) [ Time Frame: 12 months following randomization ]
    PROMIS-10 Global Quality of Life

  • COPD Symptoms [ Time Frame: 12 months following randomization ]
    COPD Assessment Test (CAT)

  • Depression [ Time Frame: 12 months following randomization ]
    Personal Health Questionnaire (PHQ-9)

  • Anxiety [ Time Frame: 12 months following randomization ]
    Generalized Anxiety Disorder (GAD-7)


Estimated Enrollment: 2700
Study Start Date: June 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard Care
Standard care patients will continue to receive their routine care from Kaiser Permanente Southern California and have access to all health services in accordance with their health plan
Experimental: Physical Activity Coaching (Walk On!)
The 12-month Walk On! intervention includes 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.
Behavioral: Physical Activity Coaching (Walk On!)
The 12-month Walk On! intervention includes 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.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   41 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02478359


Locations
United States, California
Kaiser Permanente Southern California
Pasadena, California, United States, 91101
Sponsors and Collaborators
Kaiser Permanente
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Huong Q Nguyen, PhD, RN Research Scientist
  More Information

Publications:

Responsible Party: Huong Q2 Nguyen, Research Scientist, Kaiser Permanente
ClinicalTrials.gov Identifier: NCT02478359     History of Changes
Other Study ID Numbers: KPSC IRB 12345
First Submitted: June 3, 2015
First Posted: June 23, 2015
Last Update Posted: August 29, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases