Walk On! Physical Activity Coaching

NCT02478359 | Completed Results DMC

• 1 other identifier: KPSC IRB 12345
• Study Type: interventional
• Target: 2,707
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• Number of Participants With All-cause Hospitalizations, Emergency Department (ED) Visits, Observation Stays, and Deaths

  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

  12 months following randomization

Secondary Outcomes (20)

• Number of Deaths Among Participants

  12 months following randomization

• Number of Participants With All-cause Hospitalizations

  12 months following randomization

• Number of Participants With All-cause Emergency Department Visits

  12 months following randomization

• Number of Participants With All-cause Observation Stays

  12 months following randomization

• Number of Participants With COPD-Related Hospitalizations, ED Visits, and Observation Stays

  12 months following randomization

Other Outcomes (13)

• Number of Participants With All-cause Hospitalization, Emergency Department (ED) Visits, Observation Stays and Deaths

  2 to 12 months following randomization

• Number of Deaths Among Participants

  2 to 12 months following randomization

• Number of Participants With All-cause Hospitalizations

  2 to 12 months following randomization

Study Arms (2)

Standard Care

NO INTERVENTION

Standard care patients received their routine care from Kaiser Permanente Southern California and had access to all health services in accordance with their health plan

Physical Activity Coaching (Walk On!)

EXPERIMENTAL

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.

Behavioral: Physical Activity Coaching (Walk On!)

Interventions

Physical Activity Coaching (Walk On!) BEHAVIORAL

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.

Physical Activity Coaching (Walk On!)

Eligibility Criteria

• Age: 41 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Kaiser Permanente Southern California

Pasadena, California, 91101, United States

Location

Related Publications (3)

• 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.

  PMID: 26597414 BACKGROUND

• 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.

  PMID: 30144938 BACKGROUND

• 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.

  PMID: 31418811 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

It is important to note the low uptake/participation in the Walk On! intervention and its effects on the primary, intention to treat analyses, as well, the sub-optimal baseline and follow-up response rates to the patient-reported outcomes.

Results Point of Contact

• Title: Huong Q2 Nguyen, Research Scientist
• Organization: Kaiser Permanente

huong.q2.nguyen@kp.org

626-564-3935

Study Officials

• Huong Q Nguyen, PhD, RN

  Research Scientist

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 23, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 19, 2020
• Results First Posted: February 19, 2020

Record last verified: 2020-02

Locations

US (1)