Walk On! Physical Activity Coaching

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02478359
• Other study ID #: KPSC IRB 12345
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: December 2018

Study information

• Verified date: February 2020
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2707
• Est. completion date: December 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 41 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Physical Activity Coaching (Walk On!)
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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Southern California	Pasadena	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With All-cause Hospitalization, Emergency Department (ED) Visits, Observation Stays and Deaths	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 to 12 months following randomization
Other	Number of Deaths Among Participants	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 to 12 months following randomization
Other	Number of Participants With All-cause Hospitalizations	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 to 12 months following randomization
Other	Number of Participants With All-cause Emergency Department Visits	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 to 12 months following randomization
Other	Number of Participants With All-cause Observation Stays	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 to 12 months following randomization
Other	Number of Participants With COPD-Related Hospitalizations, ED Visits, and Observation Stays	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 to 12 months randomization
Other	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.	6-12 months following randomization
Other	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.	6-12 months following randomization
Other	HbA1c Levels	HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization	12 months
Other	LDL Levels	Cholesterol levels were obtained from values closest to the 12 months post randomization	12 months
Other	HDL Levels	Cholesterol levels were obtained from values closest to the 12 months post randomization	12 months
Other	Total Cholesterol Levels	Cholesterol levels were obtained from values closest to the 12 months post randomization	12 months
Other	Triglycerides Levels	Cholesterol levels were obtained from values closest to the 12 months post randomization	12 months
Primary	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	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	12 months following randomization
Secondary	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	12 months following randomization
Secondary	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	12 months following randomization
Secondary	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	12 months following randomization
Secondary	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	12 months following randomization
Secondary	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	12 months following randomization
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months following randomization
Secondary	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.	12 months following randomization
Secondary	HbA1c Levels	HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization	12 months following randomization
Secondary	LDL Levels	Cholesterol levels were obtained from values closest to the 12 months post randomization	12 months following randomization
Secondary	HDL Levels	Cholesterol levels were obtained from values closest to the 12 months post randomization	12 months following randomization
Secondary	Total Cholesterol Levels	Cholesterol levels were obtained from values closest to the 12 months post randomization	12 months following randomization
Secondary	Triglycerides Levels	Cholesterol levels were obtained from values closest to the 12 months post randomization	12 months post randomization
Secondary	Body Mass Index	Body mass index measurements were based on values closest to the 12 months post randomization	12 months following randomization