Clinical trial NCT02478359: Walk On! Physical Activity Coaching
Official title: Patient-Centered Physical Activity Coaching in COPD: A Pragmatic Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-06-23
Enrollment: 2707
Sex: ALL
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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 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

Primary outcomes:
measure: Number of Participants With All-cause Hospitalizations, Emergency Department (ED) Visits, Observation Stays, and Deaths
timeFrame: 12 months following randomization
Secondary outcomes:
measure: Number of Deaths Among Participants
timeFrame: 12 months following randomization
measure: Number of Participants With All-cause Hospitalizations
timeFrame: 12 months following randomization
measure: Number of Participants With All-cause Emergency Department Visits
timeFrame: 12 months following randomization
measure: Number of Participants With All-cause Observation Stays
timeFrame: 12 months following randomization
measure: Number of Participants With COPD-Related Hospitalizations, ED Visits, and Observation Stays
timeFrame: 12 months following randomization
measure: Number of Participants With COPD Exacerbation
timeFrame: 12 months following randomization
measure: COPD Assessment Test, CAT - 12 Months
timeFrame: 12 months
measure: Physical Activity
timeFrame: 12 months
measure: Personal Health Questionnaire, PHQ8 - 12 Months
timeFrame: 12 months
measure: General Anxiety Disorder, GAD-7 - 12 Months
timeFrame: 12 months
measure: PROMIS-10 HRQL , Physical Health - 12 Months
timeFrame: 12 months
measure: PROMIS-10 HRQL , Mental Health - 12 Months
timeFrame: 12 months
measure: Diastolic Blood Pressure
timeFrame: 12 months following randomization
measure: Systolic Blood Pressure
timeFrame: 12 months following randomization
measure: HbA1c Levels
timeFrame: 12 months following randomization
measure: LDL Levels
timeFrame: 12 months following randomization
measure: HDL Levels
timeFrame: 12 months following randomization
measure: Total Cholesterol Levels
timeFrame: 12 months following randomization
measure: Triglycerides Levels
timeFrame: 12 months post randomization
measure: Body Mass Index
timeFrame: 12 months following randomization
Other outcomes:
measure: Number of Participants With All-cause Hospitalization, Emergency Department (ED) Visits, Observation Stays and Deaths
timeFrame: 2 to 12 months following randomization
measure: Number of Deaths Among Participants
timeFrame: 2 to 12 months following randomization
measure: Number of Participants With All-cause Hospitalizations
timeFrame: 2 to 12 months following randomization
measure: Number of Participants With All-cause Emergency Department Visits
timeFrame: 2 to 12 months following randomization
measure: Number of Participants With All-cause Observation Stays
timeFrame: 2 to 12 months following randomization
measure: Number of Participants With COPD-Related Hospitalizations, ED Visits, and Observation Stays
timeFrame: 2 to 12 months randomization
measure: Diastolic Blood Pressure
timeFrame: 6-12 months following randomization
measure: Systolic Blood Pressure
timeFrame: 6-12 months following randomization
measure: HbA1c Levels
timeFrame: 12 months
measure: LDL Levels
timeFrame: 12 months
measure: HDL Levels
timeFrame: 12 months
measure: Total Cholesterol Levels
timeFrame: 12 months
measure: Triglycerides Levels
timeFrame: 12 months
Locations:
city: Pasadena
country: United States
facility: Kaiser Permanente Southern California
state: California
Study officials:
affiliation: Research Scientist
name: Huong Q Nguyen, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Nguyen HQ, Moy ML, Liu IA, Fan VS, Gould MK, Desai SA, Towner WJ, Yuen G, Lee JS, Park SJ, Xiang AH. Effect of Physical Activity Coaching on Acute Care and Survival Among Patients With Chronic Obstructive Pulmonary Disease: A Pragmatic Randomized Clinical Trial. JAMA Netw Open. 2019 Aug 2;2(8):e199657. doi: 10.1001/jamanetworkopen.2019.9657.