Walk On! Physical Activity Coaching

Not Applicable

Completed

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Interventions: Behavioral: Physical Activity Coaching (Walk On!)

Registration Number: NCT02478359

Lead Sponsor: Kaiser Permanente

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2707

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical Activity Coaching (Walk On!)	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With All-cause Hospitalizations, Emergency Department (ED) Visits, Observation Stays, and Deaths	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 Outcome Measures

Name	Time	Method
Personal Health Questionnaire, PHQ8 - 12 Months	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	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.
Number of Participants With COPD-Related Hospitalizations, ED Visits, and Observation Stays	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	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	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	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
Physical Activity	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.
PROMIS-10 HRQL , Mental Health - 12 Months	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.
HbA1c Levels	12 months following randomization	HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization
HDL Levels	12 months following randomization	Cholesterol levels were obtained from values closest to the 12 months post randomization
Triglycerides Levels	12 months post randomization	Cholesterol levels were obtained from values closest to the 12 months post randomization
Number of Deaths Among Participants	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	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	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.
PROMIS-10 HRQL , Physical Health - 12 Months	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.
Diastolic Blood Pressure	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	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.
Body Mass Index	12 months following randomization	Body mass index measurements were based on values closest to the 12 months post randomization
LDL Levels	12 months following randomization	Cholesterol levels were obtained from values closest to the 12 months post randomization
Total Cholesterol Levels	12 months following randomization	Cholesterol levels were obtained from values closest to the 12 months post randomization