An interventional study of Physical Activity Coaching (Walk On!) in Chronic Obstructive Pulmonary Disease (COPD), sponsored by Kaiser Permanente. Completed at 1 site in United States. Open to participants aged 41 Years and older. Per ClinicalTrials.gov, last updated 2020-02-19.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Health services research
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.
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.
2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's enrollment of 2,707 is above the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →Kaiser Permanente is the lead sponsor of 385 studies on the registry; 41 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
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
Time frame: 12 months following randomization
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
Time frame: 12 months following randomization
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
Time frame: 12 months following randomization
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
Time frame: 12 months following randomization
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
Time frame: 12 months following randomization
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
Time frame: 12 months following randomization
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
Time frame: 12 months following randomization
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.
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months following randomization
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.
Time frame: 12 months following randomization
HbA1c Levels
HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization
Time frame: 12 months following randomization
LDL Levels
Cholesterol levels were obtained from values closest to the 12 months post randomization
Time frame: 12 months following randomization
HDL Levels
Cholesterol levels were obtained from values closest to the 12 months post randomization
Time frame: 12 months following randomization
Total Cholesterol Levels
Cholesterol levels were obtained from values closest to the 12 months post randomization
Time frame: 12 months following randomization
Triglycerides Levels
Cholesterol levels were obtained from values closest to the 12 months post randomization
Time frame: 12 months post randomization
Body Mass Index
Body mass index measurements were based on values closest to the 12 months post randomization
Time frame: 12 months following randomization
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.
Time frame: 2 to 12 months following randomization
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.
Time frame: 2 to 12 months following randomization
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.
Time frame: 2 to 12 months following randomization
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.
Time frame: 2 to 12 months following randomization
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.
Time frame: 2 to 12 months following randomization
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.
Time frame: 2 to 12 months randomization
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.
Time frame: 6-12 months following randomization
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.
Time frame: 6-12 months following randomization
HbA1c Levels
HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization
Time frame: 12 months
LDL Levels
Cholesterol levels were obtained from values closest to the 12 months post randomization
Time frame: 12 months
HDL Levels
Cholesterol levels were obtained from values closest to the 12 months post randomization
Time frame: 12 months
Total Cholesterol Levels
Cholesterol levels were obtained from values closest to the 12 months post randomization
Time frame: 12 months
Triglycerides Levels
Cholesterol levels were obtained from values closest to the 12 months post randomization
Time frame: 12 months
Eligible patients were randomly assigned 1:1 to Walk On! or Standard Care arm at the point of identification of eligibility based on EMR data.
| Milestone | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Started | 1349 | 1358 |
| Intention-to-treat population month 12 | 1243 | 1293 |
| Completed | 1243 | 1293 |
| Not completed | 106 | 65 |
| Withdrew: Disenrolled from health plan | 106 | 65 |
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
| Participants | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Number of Participants With All-cause Hospitalizations, Emergency Department (ED) Visits, Observation Stays, and Deaths | 864 | 883 |
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
| Participants | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Number of Deaths Among Participants | 117 | 117 |
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
| Participants | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Number of Participants With All-cause Hospitalizations | 499 | 502 |
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
| Participants | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Number of Participants With All-cause Emergency Department Visits | 694 | 702 |
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
| Participants | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Number of Participants With All-cause Observation Stays | 269 | 295 |
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
| Participants | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Number of Participants With COPD-Related Hospitalizations, ED Visits, and Observation Stays | 398 | 411 |
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
| Participants | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Number of Participants With COPD Exacerbation | 706 | 689 |
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.
| score on a scale | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Baseline | 20.5 ± 8.47 | 18.0 ± 7.28 |
| 12 months | 19.9 ± 8.03 | 17.8 ± 7.48 |
| Change at 12 months from baseline | -0.56 ± 6.46 | -0.15 ± 6.22 |
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.
| Participants | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Inactive (0 mins/wk) Baseline | 890 | 911 |
| Inactive (0 mins/wk) 12 Months | 819 | 808 |
| Insufficiently Active (1-149 mins/wk) Baseline | 262 | 245 |
| Insufficiently Active (1-149 mins/wk) 12 Months | 243 | 268 |
| Active (>=150 mins/wk) Baseline | 160 | 174 |
| Active (>=150 mins/wk) 12 Months | 171 | 182 |
The reported mean change between the baseline and 12 Months scores. Score range is 0-24. A negative change score indicates less depressive symptoms.
| score on a scale | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Baseline | 6.6 ± 6.00 | 4.9 ± 4.22 |
| 12 months | 6.3 ± 5.40 | 4.8 ± 4.10 |
| Change at 12 months from Baseline | -0.30 ± 4.66 | -0.06 ± 3.90 |
The reported mean change between the baseline and 12 Months scores. Score range is 0-21. A negative change score indicates less anxiety.
| score on a scale | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Baseline | 5.2 ± 5.81 | 4.0 ± 4.05 |
| 12 months | 4.5 ± 5.08 | 3.8 ± 4.25 |
| Changes at 12 months from Baseline | -0.63 ± 4.44 | -0.21 ± 3.63 |
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.
| score on a scale | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Baseline | 39.8 ± 8.62 | 40.7 ± 6.95 |
| 12 months | 40.3 ± 8.06 | 41.7 ± 7.18 |
| Change at 12 months from Baseline | 0.49 ± 6.72 | 0.97 ± 5.99 |
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.
| score on a scale | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Baseline | 45.3 ± 8.94 | 47.7 ± 8.80 |
| 12 months | 46.0 ± 8.65 | 47.9 ± 8.04 |
| Changes at 12 months from Baseline | 0.69 ± 7.39 | 0.26 ± 6.77 |
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.
| mmHg | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Diastolic Blood Pressure | 70.5 ± 9.59 | 70.1 ± 9.63 |
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.
| mmHg | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Systolic Blood Pressure | 130.8 ± 14.54 | 130.7 ± 14.19 |
HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization
| percentage of glycosylated hemoglobin, | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| HbA1c Levels | 7.1 ± 1.45 | 7.2 ± 1.36 |
Cholesterol levels were obtained from values closest to the 12 months post randomization
| mg/dL | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| LDL Levels | 91.0 ± 36.96 | 86.6 ± 32.51 |
Cholesterol levels were obtained from values closest to the 12 months post randomization
| mg/dL | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| HDL Levels | 54.3 ± 18.28 | 53.1 ± 17.60 |
Cholesterol levels were obtained from values closest to the 12 months post randomization
| mg/dL | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Total Cholesterol Levels | 168.8 ± 44.91 | 162.3 ± 41.82 |
Cholesterol levels were obtained from values closest to the 12 months post randomization
| mg/dL | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Triglycerides Levels | 128.3 ± 102.36 | 119.0 ± 65.60 |
Body mass index measurements were based on values closest to the 12 months post randomization
| kg/m^2 | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Body Mass Index | 26.9 ± 5.94 | 27.07 ± 5.90 |
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.
| Participants | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Number of Participants With All-cause Hospitalization, Emergency Department (ED) Visits, Observation Stays and Deaths | 781 | 185 |
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.
| Participants | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Number of Deaths Among Participants | 95 | 13 |
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.
| Participants | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Number of Participants With All-cause Hospitalizations | 433 | 91 |
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.
| Participants | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Number of Participants With All-cause Emergency Department Visits | 610 | 144 |
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.
| Participants | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Number of Participants With All-cause Observation Stays | 230 | 53 |
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.
| Participants | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Number of Participants With COPD-Related Hospitalizations, ED Visits, and Observation Stays | 195 | 48 |
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.
| mmHg | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Diastolic Blood Pressure | 70.5 ± 9.59 | 69.6 ± 8.85 |
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.
| mmHg | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Systolic Blood Pressure | 130.8 ± 14.54 | 128.8 ± 13.02 |
HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization
| percentage of glycosylated hemoglobin | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| HbA1c Levels | 7.1 ± 1.45 | 7.2 ± 1.40 |
Cholesterol levels were obtained from values closest to the 12 months post randomization
| mg/dL | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| LDL Levels | 91.0 ± 36.96 | 85.8 ± 29.92 |
Cholesterol levels were obtained from values closest to the 12 months post randomization
| mg/dL | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| HDL Levels | 54.3 ± 18.28 | 52.8 ± 16.55 |
Cholesterol levels were obtained from values closest to the 12 months post randomization
| md/dL | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Total Cholesterol Levels | 168.8 ± 44.91 | 161.4 ± 38.31 |
Cholesterol levels were obtained from values closest to the 12 months post randomization
| mg/dL | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Triglycerides Levels | 128.03 ± 102.36 | 116.2 ± 61.36 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Care | 117/1,349 (8.7%) | 499/1,349 (37%) | 963/1,349 (71.4%) |
| Physical Activity Coaching (Walk On!) | 117/1,358 (8.6%) | 502/1,358 (37%) | 997/1,358 (73.4%) |
| Event | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| All-cause hospitalizationsInvestigations | 499/1349 | 502/1358 |
| Event | Standard Care | Physical Activity Coaching (Walk On!) |
|---|---|---|
| Emergency Department VisitsInvestigations | 694/1349 | 702/1358 |
| Observational StaysInvestigations | 269/1349 | 295/1358 |
Intent-to-treat (ITT) population included all participants randomized into the study.
| Age, Categorical(Participants) | Standard Care | Physical Activity Coaching (Walk On!) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 300 | 305 | 605 |
| >=65 years | 1049 | 1053 | 2102 |
| Age, Continuous(years) | Standard Care | Physical Activity Coaching (Walk On!) | Total |
|---|---|---|---|
| Mean | 72.4 ± 10.14 | 72.4 ± 10.24 | 72.4 ± 10.19 |
| Sex: Female, Male(Participants) | Standard Care | Physical Activity Coaching (Walk On!) | Total |
|---|---|---|---|
| Female | 739 | 716 | 1455 |
| Male | 610 | 642 | 1252 |
| Race (NIH/OMB)(Participants) | Standard Care | Physical Activity Coaching (Walk On!) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 4 | 4 | 8 |
| Asian | 59 | 81 | 140 |
| Native Hawaiian or Other Pacific Islander | 6 | 13 | 19 |
| Black or African American | 188 | 187 | 375 |
| White | 1021 | 989 | 2010 |
| More than one race | 4 | 3 | 7 |
| Unknown or Not Reported | 67 | 81 | 148 |
| Region of Enrollment(participants) | Standard Care | Physical Activity Coaching (Walk On!) | Total |
|---|---|---|---|
| United States | 1349 | 1358 | 2707 |
| Smoking Status(Participants) | Standard Care | Physical Activity Coaching (Walk On!) | Total |
|---|---|---|---|
| Never | 162 | 169 | 331 |
| Former | 933 | 935 | 1868 |
| Current | 243 | 238 | 481 |
| Unknown | 11 | 16 | 27 |
| Body mass Index (BMI)(kg/m^2) | Standard Care | Physical Activity Coaching (Walk On!) | Total |
|---|---|---|---|
| Mean | 27 ± 6 | 27.1 ± 5.9 | 27.1 ± 5.9 |
| Pulmonary Rehabilitation (up to past 3 years)(Participants) | Standard Care | Physical Activity Coaching (Walk On!) | Total |
|---|---|---|---|
| Count of participants | 82 | 87 | 169 |
7 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Kaiser Permanente