Walk On! Physical Activity Coaching
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Activity Coaching (Walk On!)
Sponsored by
![Kaiser Permanente](https://trials-media.s3.amazonaws.com/orgs/kaiser-permanente.jpeg)
About this trial
This is an interventional health services research trial for Chronic Obstructive Pulmonary Disease (COPD)
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
Sites / Locations
- Kaiser Permanente Southern California
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard Care
Physical Activity Coaching (Walk On!)
Arm Description
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
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Number of Deaths Among Participants
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
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
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
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-Related Hospitalizations, ED Visits, and Observation Stays
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
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
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.
Physical Activity
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.
Personal Health Questionnaire, PHQ8 - 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
The reported mean change between the baseline and 12 Months scores. Score range is 0-21. A negative change score indicates less anxiety.
PROMIS-10 HRQL , Physical Health - 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.
PROMIS-10 HRQL , Mental Health - 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.
Diastolic Blood Pressure
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
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.
HbA1c Levels
HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization
LDL Levels
Cholesterol levels were obtained from values closest to the 12 months post randomization
HDL Levels
Cholesterol levels were obtained from values closest to the 12 months post randomization
Total Cholesterol Levels
Cholesterol levels were obtained from values closest to the 12 months post randomization
Triglycerides Levels
Cholesterol levels were obtained from values closest to the 12 months post randomization
Body Mass Index
Body mass index measurements were based on values closest to the 12 months post randomization
Full Information
NCT ID
NCT02478359
First Posted
June 3, 2015
Last Updated
February 7, 2020
Sponsor
Kaiser Permanente
Collaborators
Patient-Centered Outcomes Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02478359
Brief Title
Walk On! Physical Activity Coaching
Official Title
Patient-Centered Physical Activity Coaching in COPD: A Pragmatic Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaiser Permanente
Collaborators
Patient-Centered Outcomes Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2707 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
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
Arm Title
Physical Activity Coaching (Walk On!)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity Coaching (Walk On!)
Intervention Description
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 Measure Information:
Title
Number of Participants With All-cause Hospitalizations, Emergency Department (ED) Visits, Observation Stays, and Deaths
Description
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
Time Frame
12 months following randomization
Secondary Outcome Measure Information:
Title
Number of Deaths Among Participants
Description
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
Time Frame
12 months following randomization
Title
Number of Participants With All-cause Hospitalizations
Description
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
Time Frame
12 months following randomization
Title
Number of Participants With All-cause Emergency Department Visits
Description
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
Time Frame
12 months following randomization
Title
Number of Participants With All-cause Observation Stays
Description
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
Time Frame
12 months following randomization
Title
Number of Participants With COPD-Related Hospitalizations, ED Visits, and Observation Stays
Description
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
Time Frame
12 months following randomization
Title
Number of Participants With COPD Exacerbation
Description
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
Time Frame
12 months following randomization
Title
COPD Assessment Test, CAT - 12 Months
Description
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.
Time Frame
12 months
Title
Physical Activity
Description
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.
Time Frame
12 months
Title
Personal Health Questionnaire, PHQ8 - 12 Months
Description
The reported mean change between the baseline and 12 Months scores. Score range is 0-24. A negative change score indicates less depressive symptoms.
Time Frame
12 months
Title
General Anxiety Disorder, GAD-7 - 12 Months
Description
The reported mean change between the baseline and 12 Months scores. Score range is 0-21. A negative change score indicates less anxiety.
Time Frame
12 months
Title
PROMIS-10 HRQL , Physical Health - 12 Months
Description
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.
Time Frame
12 months
Title
PROMIS-10 HRQL , Mental Health - 12 Months
Description
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.
Time Frame
12 months
Title
Diastolic Blood Pressure
Description
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.
Time Frame
12 months following randomization
Title
Systolic Blood Pressure
Description
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.
Time Frame
12 months following randomization
Title
HbA1c Levels
Description
HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization
Time Frame
12 months following randomization
Title
LDL Levels
Description
Cholesterol levels were obtained from values closest to the 12 months post randomization
Time Frame
12 months following randomization
Title
HDL Levels
Description
Cholesterol levels were obtained from values closest to the 12 months post randomization
Time Frame
12 months following randomization
Title
Total Cholesterol Levels
Description
Cholesterol levels were obtained from values closest to the 12 months post randomization
Time Frame
12 months following randomization
Title
Triglycerides Levels
Description
Cholesterol levels were obtained from values closest to the 12 months post randomization
Time Frame
12 months post randomization
Title
Body Mass Index
Description
Body mass index measurements were based on values closest to the 12 months post randomization
Time Frame
12 months following randomization
Other Pre-specified Outcome Measures:
Title
Number of Participants With All-cause Hospitalization, Emergency Department (ED) Visits, Observation Stays and Deaths
Description
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.
Time Frame
2 to 12 months following randomization
Title
Number of Deaths Among Participants
Description
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.
Time Frame
2 to 12 months following randomization
Title
Number of Participants With All-cause Hospitalizations
Description
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.
Time Frame
2 to 12 months following randomization
Title
Number of Participants With All-cause Emergency Department Visits
Description
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.
Time Frame
2 to 12 months following randomization
Title
Number of Participants With All-cause Observation Stays
Description
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.
Time Frame
2 to 12 months following randomization
Title
Number of Participants With COPD-Related Hospitalizations, ED Visits, and Observation Stays
Description
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.
Time Frame
2 to 12 months randomization
Title
Diastolic Blood Pressure
Description
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.
Time Frame
6-12 months following randomization
Title
Systolic Blood Pressure
Description
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.
Time Frame
6-12 months following randomization
Title
HbA1c Levels
Description
HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization
Time Frame
12 months
Title
LDL Levels
Description
Cholesterol levels were obtained from values closest to the 12 months post randomization
Time Frame
12 months
Title
HDL Levels
Description
Cholesterol levels were obtained from values closest to the 12 months post randomization
Time Frame
12 months
Title
Total Cholesterol Levels
Description
Cholesterol levels were obtained from values closest to the 12 months post randomization
Time Frame
12 months
Title
Triglycerides Levels
Description
Cholesterol levels were obtained from values closest to the 12 months post randomization
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huong Q Nguyen, PhD, RN
Organizational Affiliation
Research Scientist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Southern California
City
Pasadena
State/Province
California
ZIP/Postal Code
91101
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26597414
Citation
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.
Results Reference
background
PubMed Identifier
30144938
Citation
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.
Results Reference
background
PubMed Identifier
31418811
Citation
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.
Results Reference
derived
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Walk On! Physical Activity Coaching
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