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Completed

NCT Number: NCT02478359

Walk On! Physical Activity Coaching

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

41 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Southern California

Pasadena, California, 91101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Number of Deaths Among Participants

    Time frame: 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

  2. Number of Participants With All-cause Hospitalizations

    Time frame: 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

  3. Number of Participants With All-cause Emergency Department Visits

    Time frame: 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

  4. Number of Participants With All-cause Observation Stays

    Time frame: 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

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

    Time frame: 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

  6. Number of Participants With COPD Exacerbation

    Time frame: 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

  7. COPD Assessment Test, CAT - 12 Months

    Time frame: 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.

  8. Physical Activity

    Time frame: 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.

  9. Personal Health Questionnaire, PHQ8 - 12 Months

    Time frame: 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.

  10. General Anxiety Disorder, GAD-7 - 12 Months

    Time frame: 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.

  11. PROMIS-10 HRQL , Physical Health - 12 Months

    Time frame: 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.

  12. PROMIS-10 HRQL , Mental Health - 12 Months

    Time frame: 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.

  13. Diastolic Blood Pressure

    Time frame: 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.

  14. Systolic Blood Pressure

    Time frame: 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.

  15. HbA1c Levels

    Time frame: 12 months following randomization

    HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization

  16. LDL Levels

    Time frame: 12 months following randomization

    Cholesterol levels were obtained from values closest to the 12 months post randomization

  17. HDL Levels

    Time frame: 12 months following randomization

    Cholesterol levels were obtained from values closest to the 12 months post randomization

  18. Total Cholesterol Levels

    Time frame: 12 months following randomization

    Cholesterol levels were obtained from values closest to the 12 months post randomization

  19. Triglycerides Levels

    Time frame: 12 months post randomization

    Cholesterol levels were obtained from values closest to the 12 months post randomization

  20. Body Mass Index

    Time frame: 12 months following randomization

    Body mass index measurements were based on values closest to the 12 months post randomization

Other outcomes

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

    Time frame: 2 to 12 months following randomization

    As-treated analyses using logistic regression models that included stabilized propensity score inverse probability of treatment weighting (IPTW) to balance baseline characteristics (socio-demographics, health behaviors, disease severity, comorbidities, inhalers/medications, and health care utilization in the prior year) between patients who participated in Walk On! intervention and the SC group. The first 2 months after randomization were excluded because it was expected that it would take approximately 2 months form the date of randomization to start the intervention.

  2. Number of Deaths Among Participants

    Time frame: 2 to 12 months following randomization

    As-treated analyses using logistic regression models that included stabilized propensity score inverse probability of treatment weighting (IPTW) to balance baseline characteristics (socio-demographics, health behaviors, disease severity, comorbidities, inhalers/medications, and health care utilization in the prior year) between patients who participated in Walk On! intervention and the SC group. The first 2 months after randomization were excluded because it was expected that it would take approximately 2 months form the date of randomization to start the intervention.

  3. Number of Participants With All-cause Hospitalizations

    Time frame: 2 to 12 months following randomization

    As-treated analyses using logistic regression models that included stabilized propensity score inverse probability of treatment weighting (IPTW) to balance baseline characteristics (socio-demographics, health behaviors, disease severity, comorbidities, inhalers/medications, and health care utilization in the prior year) between patients who participated in Walk On! intervention and the SC group. The first 2 months after randomization were excluded because it was expected that it would take approximately 2 months form the date of randomization to start the intervention.

  4. Number of Participants With All-cause Emergency Department Visits

    Time frame: 2 to 12 months following randomization

    As-treated analyses using logistic regression models that included stabilized propensity score inverse probability of treatment weighting (IPTW) to balance baseline characteristics (socio-demographics, health behaviors, disease severity, comorbidities, inhalers/medications, and health care utilization in the prior year) between patients who participated in Walk On! intervention and the SC group. The first 2 months after randomization were excluded because it was expected that it would take approximately 2 months form the date of randomization to start the intervention.

  5. Number of Participants With All-cause Observation Stays

    Time frame: 2 to 12 months following randomization

    As-treated analyses using logistic regression models that included stabilized propensity score inverse probability of treatment weighting (IPTW) to balance baseline characteristics (socio-demographics, health behaviors, disease severity, comorbidities, inhalers/medications, and health care utilization in the prior year) between patients who participated in Walk On! intervention and the SC group. The first 2 months after randomization were excluded because it was expected that it would take approximately 2 months form the date of randomization to start the intervention.

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

    Time frame: 2 to 12 months randomization

    As-treated analyses using logistic regression models that included stabilized propensity score inverse probability of treatment weighting (IPTW) to balance baseline characteristics (socio-demographics, health behaviors, disease severity, comorbidities, inhalers/medications, and health care utilization in the prior year) between patients who participated in Walk On! intervention and the SC group. The first 2 months after randomization were excluded because it was expected that it would take approximately 2 months form the date of randomization to start the intervention.

  7. Diastolic Blood Pressure

    Time frame: 6-12 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.

  8. Systolic Blood Pressure

    Time frame: 6-12 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.

  9. HbA1c Levels

    Time frame: 12 months

    HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization

  10. LDL Levels

    Time frame: 12 months

    Cholesterol levels were obtained from values closest to the 12 months post randomization

  11. HDL Levels

    Time frame: 12 months

    Cholesterol levels were obtained from values closest to the 12 months post randomization

  12. Total Cholesterol Levels

    Time frame: 12 months

    Cholesterol levels were obtained from values closest to the 12 months post randomization

  13. Triglycerides Levels

    Time frame: 12 months

    Cholesterol levels were obtained from values closest to the 12 months post randomization

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Patient-Centered Physical Activity Coaching in COPD: A Pragmatic Trial

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 23, 2015
Registry last updated
Feb 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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