N/A N=2,707 Randomized Single-blind Health Services Research

Walk On! Physical Activity Coaching

Chronic Obstructive Pulmonary Disease (COPD)

Bottom Line

View on ClinicalTrials.gov: NCT02478359 ↗

Enrolled (actual)

2,707

Serious AEs

37.0%

Results posted

Feb 2020

Primary outcome: Primary: Number of Participants With All-cause Hospitalizations, Emergency Department (ED) Visits, Observation Stays, and Deaths — 864; 883 Participants — p=0.33

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Physical Activity Coaching (Walk On!) (Behavioral)
Age: Adult, Older Adult · 41+ yrs
Sex: All
Sponsor: Kaiser Permanente
Primary completion: Aug 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With All-cause Hospitalizations, Emergency Department (ED) Visits, Observation Stays, and Deaths	864; 883	0.33
SECONDARY Number of Deaths Among Participants	95; 13	0.11
SECONDARY Number of Participants With All-cause Hospitalizations	433; 91	0.21
SECONDARY Number of Participants With All-cause Emergency Department Visits	610; 144	0.60
SECONDARY Number of Participants With All-cause Observation Stays	230; 53	0.63
SECONDARY Number of Participants With COPD-Related Hospitalizations, ED Visits, and Observation Stays	195; 48	0.80
SECONDARY Number of Participants With COPD Exacerbation	706; 689	0.41
SECONDARY COPD Assessment Test, CAT - 12 Months	20.5; 18.0; 19.9; 17.8; -0.56; -0.15	0.55
SECONDARY Physical Activity	890; 911; 819; 808; 262; 245	0.34
SECONDARY Personal Health Questionnaire, PHQ8 - 12 Months	6.6; 4.9; 6.3; 4.8; -0.30; -0.06	0.60
SECONDARY General Anxiety Disorder, GAD-7 - 12 Months	5.2; 4.0; 4.5; 3.8; -0.63; -0.21	0.32
SECONDARY PROMIS-10 HRQL , Physical Health - 12 Months	39.8; 40.7; 40.3; 41.7; 0.49; 0.97	0.47
SECONDARY PROMIS-10 HRQL , Mental Health - 12 Months	45.3; 47.7; 46.0; 47.9; 0.69; 0.26	0.33
SECONDARY Diastolic Blood Pressure	70.5; 69.6	0.06
SECONDARY Systolic Blood Pressure	130.8; 128.8	0.07
SECONDARY HbA1c Levels	7.1; 7.2	0.67
SECONDARY LDL Levels	91.0; 85.8	0.13
SECONDARY HDL Levels	54.3; 52.8	0.34
SECONDARY Total Cholesterol Levels	168.8; 161.4	0.11
SECONDARY Triglycerides Levels	128.03; 116.2	0.83
SECONDARY Body Mass Index	26.9; 27.07	0.57

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02478359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.