Walk On! Physical Activity Coaching
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 41 - Any |
| Updated: | 10/3/2018 |
| Start Date: | June 2015 |
| End Date: | December 2018 |
Patient-Centered Physical Activity Coaching in COPD: A Pragmatic Trial
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.
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
