Chronic Obstructive Pulmonary Disease (COPD)
Conditions
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.
Interventions
BEHAVIORALPhysical 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.
Sponsors
Patient-Centered Outcomes Research Institute
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
41 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With All-cause Hospitalizations, Emergency Department (ED) Visits, Observation Stays, and Deaths | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With All-cause Observation Stays | 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 |
| COPD Assessment Test, CAT - 12 Months | 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 | 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. |
| Personal Health Questionnaire, PHQ8 - 12 Months | 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 | 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 , Mental Health - 12 Months | 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 | 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. |
| Systolic Blood Pressure | 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. |
| HbA1c Levels | 12 months following randomization | HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization |
| LDL Levels | 12 months following randomization | Cholesterol levels were obtained from values closest to the 12 months post randomization |
| HDL Levels | 12 months following randomization | Cholesterol levels were obtained from values closest to the 12 months post randomization |
| Total Cholesterol Levels | 12 months following randomization | Cholesterol levels were obtained from values closest to the 12 months post randomization |
| Triglycerides Levels | 12 months post randomization | Cholesterol levels were obtained from values closest to the 12 months post randomization |
| Body Mass Index | 12 months following randomization | Body mass index measurements were based on values closest to the 12 months post randomization |
| PROMIS-10 HRQL , Physical Health - 12 Months | 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. |
| Number of Deaths Among Participants | 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 |
| Number of Participants With All-cause Hospitalizations | 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 |
| Number of Participants With All-cause Emergency Department Visits | 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 |
| Number of Participants With COPD-Related Hospitalizations, ED Visits, and Observation Stays | 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 |
| Number of Participants With COPD Exacerbation | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With All-cause Hospitalizations | 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. |
| Number of Participants With All-cause Emergency Department Visits | 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. |
| Number of Participants With All-cause Observation Stays | 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. |
| Number of Participants With COPD-Related Hospitalizations, ED Visits, and Observation Stays | 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. |
| Diastolic Blood Pressure | 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. |
| Systolic Blood Pressure | 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. |
| HbA1c Levels | 12 months | HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization |
| LDL Levels | 12 months | Cholesterol levels were obtained from values closest to the 12 months post randomization |
| HDL Levels | 12 months | Cholesterol levels were obtained from values closest to the 12 months post randomization |
| Total Cholesterol Levels | 12 months | Cholesterol levels were obtained from values closest to the 12 months post randomization |
| Triglycerides Levels | 12 months | Cholesterol levels were obtained from values closest to the 12 months post randomization |
| Number of Participants With All-cause Hospitalization, Emergency Department (ED) Visits, Observation Stays and Deaths | 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. |
| Number of Deaths Among Participants | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Patients assigned to the Walk On! arm were all approached to participate in and consent to the intervention activities. Only a randomly selected subgroup within Standard Care (n=537) were approached to complete surveys for comparison with the Walk On! group.
Participants by arm
| Arm | Count |
|---|---|
| Standard Care 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 | 1,349 |
| 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. | 1,358 |
| Total | 2,707 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Disenrolled from health plan | 106 | 65 |
Baseline characteristics
| Characteristic | Physical Activity Coaching (Walk On!) | Total | Standard Care |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1053 Participants | 2102 Participants | 1049 Participants |
| Age, Categorical Between 18 and 65 years | 305 Participants | 605 Participants | 300 Participants |
| Age, Continuous | 72.4 years STANDARD_DEVIATION 10.24 | 72.4 years STANDARD_DEVIATION 10.19 | 72.4 years STANDARD_DEVIATION 10.14 |
| All Cause Acute Care Utilization in the 12-months Prior to Randomization Emergency department visits | 1039 Participants | 2089 Participants | 1050 Participants |
| All Cause Acute Care Utilization in the 12-months Prior to Randomization Hospitalizations | 702 Participants | 1437 Participants | 735 Participants |
| All Cause Acute Care Utilization in the 12-months Prior to Randomization Observation stay | 392 Participants | 786 Participants | 394 Participants |
| Body mass Index (BMI) | 27.1 kg/m^2 STANDARD_DEVIATION 5.9 | 27.1 kg/m^2 STANDARD_DEVIATION 5.9 | 27 kg/m^2 STANDARD_DEVIATION 6 |
| Charlson Comorbidity Index score Score 0-2 | 516 Participants | 1022 Participants | 506 Participants |
| Charlson Comorbidity Index score Score 3 | 231 Participants | 441 Participants | 210 Participants |
| Charlson Comorbidity Index score Score 4-5 | 332 Participants | 680 Participants | 348 Participants |
| Charlson Comorbidity Index score Score 6+ | 279 Participants | 564 Participants | 285 Participants |
| Comorbidity Anxiety | 359 Participants | 742 Participants | 383 Participants |
| Comorbidity Chronic Pain | 272 Participants | 545 Participants | 273 Participants |
| Comorbidity Depression | 380 Participants | 741 Participants | 361 Participants |
| Comorbidity Diabetes | 417 Participants | 873 Participants | 456 Participants |
| Comorbidity Heart Failture | 407 Participants | 805 Participants | 398 Participants |
| Comorbidity Pulmonary Hypertension | 73 Participants | 143 Participants | 70 Participants |
| COPD-Related Acute Care Utilization in the 12-months Prior to Randomization Emergency department visits | 765 Participants | 1531 Participants | 766 Participants |
| COPD-Related Acute Care Utilization in the 12-months Prior to Randomization Hospitalization | 539 Participants | 1107 Participants | 568 Participants |
| COPD-Related Acute Care Utilization in the 12-months Prior to Randomization Observation Stays | 237 Participants | 480 Participants | 243 Participants |
| COPD-Related Acute Care Utilization in the 12-months Prior to Randomization Outpatient treated COPD exacerbations | 936 Participants | 1902 Participants | 966 Participants |
| Medication Inhaled corticosteroids (ICS) | 1053 Participants | 2147 Participants | 1094 Participants |
| Medication LABA & ICS | 797 Participants | 1641 Participants | 844 Participants |
| Medication LAMA & ICS | 613 Participants | 1244 Participants | 631 Participants |
| Medication Long-lasting anticholinergic (LAMA) | 720 Participants | 1422 Participants | 702 Participants |
| Medication Long-lasting beta-agonists (LABA) | 800 Participants | 1646 Participants | 846 Participants |
| Medication Long-term systemic corticosteroids | 112 Participants | 243 Participants | 131 Participants |
| Medication Oxygen-use | 509 Participants | 1059 Participants | 550 Participants |
| Pulmonary Rehabilitation (up to past 3 years) | 87 Participants | 169 Participants | 82 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 81 Participants | 140 Participants | 59 Participants |
| Race (NIH/OMB) Black or African American | 187 Participants | 375 Participants | 188 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 13 Participants | 19 Participants | 6 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 81 Participants | 148 Participants | 67 Participants |
| Race (NIH/OMB) White | 989 Participants | 2010 Participants | 1021 Participants |
| Region of Enrollment United States | 1358 participants | 2707 participants | 1349 participants |
| Sex: Female, Male Female | 716 Participants | 1455 Participants | 739 Participants |
| Sex: Female, Male Male | 642 Participants | 1252 Participants | 610 Participants |
| Smoking Status Current | 238 Participants | 481 Participants | 243 Participants |
| Smoking Status Former | 935 Participants | 1868 Participants | 933 Participants |
| Smoking Status Never | 169 Participants | 331 Participants | 162 Participants |
| Smoking Status Unknown | 16 Participants | 27 Participants | 11 Participants |
| Spirometry - FEV1/FVC ratio | 55.4 Ratio (X100) STANDARD_DEVIATION 13.9 | 55.1 Ratio (X100) STANDARD_DEVIATION 14.3 | 54.8 Ratio (X100) STANDARD_DEVIATION 14.7 |
| Spirometry - FEV1 % Predicted | 62.1 % STANDARD_DEVIATION 23.1 | 61.0 % STANDARD_DEVIATION 22.5 | 60 % STANDARD_DEVIATION 21.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 117 / 1,349 | 117 / 1,358 |
| other Total, other adverse events | 963 / 1,349 | 997 / 1,358 |
| serious Total, serious adverse events | 499 / 1,349 | 502 / 1,358 |
Outcome results
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
Time frame: 12 months following randomization
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Number of Participants With All-cause Hospitalizations, Emergency Department (ED) Visits, Observation Stays, and Deaths | 864 Participants |
| Physical Activity Coaching (Walk On!) | Number of Participants With All-cause Hospitalizations, Emergency Department (ED) Visits, Observation Stays, and Deaths | 883 Participants |
p-value: 0.3395% CI: [0.92, 1.28]Regression, Logistic
Secondary
Body Mass Index
Body mass index measurements were based on values closest to the 12 months post randomization
Time frame: 12 months following randomization
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Body Mass Index | 26.9 kg/m^2 | Standard Deviation 5.94 |
| Physical Activity Coaching (Walk On!) | Body Mass Index | 27.07 kg/m^2 | Standard Deviation 5.9 |
p-value: 0.57t-test, 2 sided
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.
Time frame: 12 months
Population: As treated population who completed the survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Care | COPD Assessment Test, CAT - 12 Months | Baseline | 20.5 score on a scale | Standard Deviation 8.47 |
| Standard Care | COPD Assessment Test, CAT - 12 Months | 12 months | 19.9 score on a scale | Standard Deviation 8.03 |
| Standard Care | COPD Assessment Test, CAT - 12 Months | Change at 12 months from baseline | -0.56 score on a scale | Standard Deviation 6.46 |
| Physical Activity Coaching (Walk On!) | COPD Assessment Test, CAT - 12 Months | Baseline | 18.0 score on a scale | Standard Deviation 7.28 |
| Physical Activity Coaching (Walk On!) | COPD Assessment Test, CAT - 12 Months | 12 months | 17.8 score on a scale | Standard Deviation 7.48 |
| Physical Activity Coaching (Walk On!) | COPD Assessment Test, CAT - 12 Months | Change at 12 months from baseline | -0.15 score on a scale | Standard Deviation 6.22 |
p-value: 0.55Regression, Linear
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.
Time frame: 12 months following randomization
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Diastolic Blood Pressure | 70.5 mmHg | Standard Deviation 9.59 |
| Physical Activity Coaching (Walk On!) | Diastolic Blood Pressure | 70.1 mmHg | Standard Deviation 9.63 |
Comparison: 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 sitep-value: 0.87Regression, Linear
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.
Time frame: 12 months
Population: As treated population who completed the survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Care | General Anxiety Disorder, GAD-7 - 12 Months | Baseline | 5.2 score on a scale | Standard Deviation 5.81 |
| Standard Care | General Anxiety Disorder, GAD-7 - 12 Months | 12 months | 4.5 score on a scale | Standard Deviation 5.08 |
| Standard Care | General Anxiety Disorder, GAD-7 - 12 Months | Changes at 12 months from Baseline | -0.63 score on a scale | Standard Deviation 4.44 |
| Physical Activity Coaching (Walk On!) | General Anxiety Disorder, GAD-7 - 12 Months | Baseline | 4.0 score on a scale | Standard Deviation 4.05 |
| Physical Activity Coaching (Walk On!) | General Anxiety Disorder, GAD-7 - 12 Months | 12 months | 3.8 score on a scale | Standard Deviation 4.25 |
| Physical Activity Coaching (Walk On!) | General Anxiety Disorder, GAD-7 - 12 Months | Changes at 12 months from Baseline | -0.21 score on a scale | Standard Deviation 3.63 |
p-value: 0.32Regression, Linear
Secondary
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
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | HbA1c Levels | 7.1 percentage of glycosylated hemoglobin, | Standard Deviation 1.45 |
| Physical Activity Coaching (Walk On!) | HbA1c Levels | 7.2 percentage of glycosylated hemoglobin, | Standard Deviation 1.36 |
Comparison: 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 sitep-value: 0.35Regression, Linear
Secondary
HDL Levels
Cholesterol levels were obtained from values closest to the 12 months post randomization
Time frame: 12 months following randomization
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | HDL Levels | 54.3 mg/dL | Standard Deviation 18.28 |
| Physical Activity Coaching (Walk On!) | HDL Levels | 53.1 mg/dL | Standard Deviation 17.6 |
Comparison: 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 sitep-value: 0.82Regression, Linear
Secondary
LDL Levels
Cholesterol levels were obtained from values closest to the 12 months post randomization
Time frame: 12 months following randomization
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | LDL Levels | 91.0 mg/dL | Standard Deviation 36.96 |
| Physical Activity Coaching (Walk On!) | LDL Levels | 86.6 mg/dL | Standard Deviation 32.51 |
Comparison: 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 sitep-value: 0.09Regression, Linear
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
Time frame: 12 months following randomization
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Number of Deaths Among Participants | 117 Participants |
| Physical Activity Coaching (Walk On!) | Number of Deaths Among Participants | 117 Participants |
p-value: 0.8895% CI: [0.77, 1.36]Regression, Logistic
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
Time frame: 12 months following randomization
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Number of Participants With All-cause Emergency Department Visits | 694 Participants |
| Physical Activity Coaching (Walk On!) | Number of Participants With All-cause Emergency Department Visits | 702 Participants |
p-value: 0.7395% CI: [0.88, 1.2]Regression, Logistic
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
Time frame: 12 months following randomization
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Number of Participants With All-cause Hospitalizations | 499 Participants |
| Physical Activity Coaching (Walk On!) | Number of Participants With All-cause Hospitalizations | 502 Participants |
p-value: 0.5395% CI: [0.89, 1.24]Regression, Logistic
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
Time frame: 12 months following randomization
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Number of Participants With All-cause Observation Stays | 269 Participants |
| Physical Activity Coaching (Walk On!) | Number of Participants With All-cause Observation Stays | 295 Participants |
p-value: 0.2195% CI: [0.93, 1.37]Regression, Logistic
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
Time frame: 12 months following randomization
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Number of Participants With COPD Exacerbation | 706 Participants |
| Physical Activity Coaching (Walk On!) | Number of Participants With COPD Exacerbation | 689 Participants |
p-value: 0.41t-test, 2 sided
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
Time frame: 12 months following randomization
Population: ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Number of Participants With COPD-Related Hospitalizations, ED Visits, and Observation Stays | 398 Participants |
| Physical Activity Coaching (Walk On!) | Number of Participants With COPD-Related Hospitalizations, ED Visits, and Observation Stays | 411 Participants |
p-value: 0.2695% CI: [0.93, 1.31]Regression, Logistic
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.
Time frame: 12 months
Population: As treated population who completed the survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Care | Personal Health Questionnaire, PHQ8 - 12 Months | Baseline | 6.6 score on a scale | Standard Deviation 6 |
| Standard Care | Personal Health Questionnaire, PHQ8 - 12 Months | 12 months | 6.3 score on a scale | Standard Deviation 5.4 |
| Standard Care | Personal Health Questionnaire, PHQ8 - 12 Months | Change at 12 months from Baseline | -0.30 score on a scale | Standard Deviation 4.66 |
| Physical Activity Coaching (Walk On!) | Personal Health Questionnaire, PHQ8 - 12 Months | Baseline | 4.9 score on a scale | Standard Deviation 4.22 |
| Physical Activity Coaching (Walk On!) | Personal Health Questionnaire, PHQ8 - 12 Months | 12 months | 4.8 score on a scale | Standard Deviation 4.1 |
| Physical Activity Coaching (Walk On!) | Personal Health Questionnaire, PHQ8 - 12 Months | Change at 12 months from Baseline | -0.06 score on a scale | Standard Deviation 3.9 |
p-value: 0.6Regression, Linear
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.
Time frame: 12 months
Population: ITT population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Care | Physical Activity | Inactive (0 mins/wk) Baseline | 890 Participants |
| Standard Care | Physical Activity | Inactive (0 mins/wk) 12 Months | 819 Participants |
| Standard Care | Physical Activity | Insufficiently Active (1-149 mins/wk) Baseline | 262 Participants |
| Standard Care | Physical Activity | Insufficiently Active (1-149 mins/wk) 12 Months | 243 Participants |
| Standard Care | Physical Activity | Active (>=150 mins/wk) Baseline | 160 Participants |
| Standard Care | Physical Activity | Active (>=150 mins/wk) 12 Months | 171 Participants |
| Physical Activity Coaching (Walk On!) | Physical Activity | Active (>=150 mins/wk) Baseline | 174 Participants |
| Physical Activity Coaching (Walk On!) | Physical Activity | Inactive (0 mins/wk) Baseline | 911 Participants |
| Physical Activity Coaching (Walk On!) | Physical Activity | Insufficiently Active (1-149 mins/wk) 12 Months | 268 Participants |
| Physical Activity Coaching (Walk On!) | Physical Activity | Inactive (0 mins/wk) 12 Months | 808 Participants |
| Physical Activity Coaching (Walk On!) | Physical Activity | Active (>=150 mins/wk) 12 Months | 182 Participants |
| Physical Activity Coaching (Walk On!) | Physical Activity | Insufficiently Active (1-149 mins/wk) Baseline | 245 Participants |
Comparison: 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 sitep-value: 0.34Regression, Logistic
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.
Time frame: 12 months
Population: As treated population who completed the survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Care | PROMIS-10 HRQL , Mental Health - 12 Months | Baseline | 45.3 score on a scale | Standard Deviation 8.94 |
| Standard Care | PROMIS-10 HRQL , Mental Health - 12 Months | 12 months | 46.0 score on a scale | Standard Deviation 8.65 |
| Standard Care | PROMIS-10 HRQL , Mental Health - 12 Months | Changes at 12 months from Baseline | 0.69 score on a scale | Standard Deviation 7.39 |
| Physical Activity Coaching (Walk On!) | PROMIS-10 HRQL , Mental Health - 12 Months | Baseline | 47.7 score on a scale | Standard Deviation 8.8 |
| Physical Activity Coaching (Walk On!) | PROMIS-10 HRQL , Mental Health - 12 Months | 12 months | 47.9 score on a scale | Standard Deviation 8.04 |
| Physical Activity Coaching (Walk On!) | PROMIS-10 HRQL , Mental Health - 12 Months | Changes at 12 months from Baseline | 0.26 score on a scale | Standard Deviation 6.77 |
p-value: 0.33Regression, Linear
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.
Time frame: 12 months
Population: As treated population who completed the survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Care | PROMIS-10 HRQL , Physical Health - 12 Months | Baseline | 39.8 score on a scale | Standard Deviation 8.62 |
| Standard Care | PROMIS-10 HRQL , Physical Health - 12 Months | 12 months | 40.3 score on a scale | Standard Deviation 8.06 |
| Standard Care | PROMIS-10 HRQL , Physical Health - 12 Months | Change at 12 months from Baseline | 0.49 score on a scale | Standard Deviation 6.72 |
| Physical Activity Coaching (Walk On!) | PROMIS-10 HRQL , Physical Health - 12 Months | Baseline | 40.7 score on a scale | Standard Deviation 6.95 |
| Physical Activity Coaching (Walk On!) | PROMIS-10 HRQL , Physical Health - 12 Months | 12 months | 41.7 score on a scale | Standard Deviation 7.18 |
| Physical Activity Coaching (Walk On!) | PROMIS-10 HRQL , Physical Health - 12 Months | Change at 12 months from Baseline | 0.97 score on a scale | Standard Deviation 5.99 |
p-value: 0.47Regression, Linear
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.
Time frame: 12 months following randomization
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Systolic Blood Pressure | 130.8 mmHg | Standard Deviation 14.54 |
| Physical Activity Coaching (Walk On!) | Systolic Blood Pressure | 130.7 mmHg | Standard Deviation 14.19 |
Comparison: 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 sitep-value: 0.7Regression, Linear
Secondary
Total Cholesterol Levels
Cholesterol levels were obtained from values closest to the 12 months post randomization
Time frame: 12 months following randomization
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Total Cholesterol Levels | 168.8 mg/dL | Standard Deviation 44.91 |
| Physical Activity Coaching (Walk On!) | Total Cholesterol Levels | 162.3 mg/dL | Standard Deviation 41.82 |
Comparison: 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 sitep-value: 0.16Regression, Linear
Secondary
Triglycerides Levels
Cholesterol levels were obtained from values closest to the 12 months post randomization
Time frame: 12 months post randomization
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Triglycerides Levels | 128.3 mg/dL | Standard Deviation 102.36 |
| Physical Activity Coaching (Walk On!) | Triglycerides Levels | 119.0 mg/dL | Standard Deviation 65.6 |
Comparison: 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 sitep-value: 0.86Regression, Linear
Other Pre-specified
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
Population: As-treated Walk On population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Diastolic Blood Pressure | 70.5 mmHg | Standard Deviation 9.59 |
| Physical Activity Coaching (Walk On!) | Diastolic Blood Pressure | 69.6 mmHg | Standard Deviation 8.85 |
Comparison: Covariates included in the as-treated adjusted linear regression analyses 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 sitep-value: 0.06Regression, Linear
Other Pre-specified
HbA1c Levels
HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization
Time frame: 12 months
Population: As-treated Walk On population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | HbA1c Levels | 7.1 percentage of glycosylated hemoglobin | Standard Deviation 1.45 |
| Physical Activity Coaching (Walk On!) | HbA1c Levels | 7.2 percentage of glycosylated hemoglobin | Standard Deviation 1.4 |
Comparison: Covariates included in the as-treated adjusted linear regression analyses were 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 sitep-value: 0.67Regression, Linear
Other Pre-specified
HDL Levels
Cholesterol levels were obtained from values closest to the 12 months post randomization
Time frame: 12 months
Population: As-treated Walk On population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | HDL Levels | 54.3 mg/dL | Standard Deviation 18.28 |
| Physical Activity Coaching (Walk On!) | HDL Levels | 52.8 mg/dL | Standard Deviation 16.55 |
Comparison: Covariates included in the as-treated adjusted linear regression analyses 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 sitep-value: 0.34Regression, Linear
Other Pre-specified
LDL Levels
Cholesterol levels were obtained from values closest to the 12 months post randomization
Time frame: 12 months
Population: As-treated Walk On population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | LDL Levels | 91.0 mg/dL | Standard Deviation 36.96 |
| Physical Activity Coaching (Walk On!) | LDL Levels | 85.8 mg/dL | Standard Deviation 29.92 |
Comparison: Covariates included in the as-treated adjusted linear regression analyses 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 sitep-value: 0.13Regression, Linear
Other Pre-specified
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
Population: As-treated population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Number of Deaths Among Participants | 95 Participants |
| Physical Activity Coaching (Walk On!) | Number of Deaths Among Participants | 13 Participants |
p-value: 0.1195% CI: [0.35, 1.11]Regression, Logistic
Other Pre-specified
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
Population: As-treated population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Number of Participants With All-cause Emergency Department Visits | 610 Participants |
| Physical Activity Coaching (Walk On!) | Number of Participants With All-cause Emergency Department Visits | 144 Participants |
p-value: 0.695% CI: [0.84, 1.36]Regression, Logistic
Other Pre-specified
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
Population: As-treated population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Number of Participants With All-cause Hospitalization, Emergency Department (ED) Visits, Observation Stays and Deaths | 781 Participants |
| Physical Activity Coaching (Walk On!) | Number of Participants With All-cause Hospitalization, Emergency Department (ED) Visits, Observation Stays and Deaths | 185 Participants |
p-value: 0.6995% CI: [0.82, 1.35]Regression, Logistic
Other Pre-specified
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
Population: As-treated population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Number of Participants With All-cause Hospitalizations | 433 Participants |
| Physical Activity Coaching (Walk On!) | Number of Participants With All-cause Hospitalizations | 91 Participants |
p-value: 0.2195% CI: [0.65, 1.1]Regression, Logistic
Other Pre-specified
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
Population: As-treated population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Number of Participants With All-cause Observation Stays | 230 Participants |
| Physical Activity Coaching (Walk On!) | Number of Participants With All-cause Observation Stays | 53 Participants |
p-value: 0.6395% CI: [0.66, 1.28]Regression, Logistic
Other Pre-specified
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
Population: As-treated population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Number of Participants With COPD-Related Hospitalizations, ED Visits, and Observation Stays | 195 Participants |
| Physical Activity Coaching (Walk On!) | Number of Participants With COPD-Related Hospitalizations, ED Visits, and Observation Stays | 48 Participants |
p-value: 0.895% CI: [0.68, 1.35]Regression, Logistic
Other Pre-specified
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
Population: As-treated Walk On population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Systolic Blood Pressure | 130.8 mmHg | Standard Deviation 14.54 |
| Physical Activity Coaching (Walk On!) | Systolic Blood Pressure | 128.8 mmHg | Standard Deviation 13.02 |
Comparison: Covariates included in the as-treated adjusted linear regression analyses 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 sitep-value: 0.07Regression, Linear
Other Pre-specified
Total Cholesterol Levels
Cholesterol levels were obtained from values closest to the 12 months post randomization
Time frame: 12 months
Population: As-treated Walk On population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Total Cholesterol Levels | 168.8 md/dL | Standard Deviation 44.91 |
| Physical Activity Coaching (Walk On!) | Total Cholesterol Levels | 161.4 md/dL | Standard Deviation 38.31 |
Comparison: Covariates included in the as-treated adjusted linear regression analyses 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 sitep-value: 0.11Regression, Linear
Other Pre-specified
Triglycerides Levels
Cholesterol levels were obtained from values closest to the 12 months post randomization
Time frame: 12 months
Population: As-treated Walk On population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Triglycerides Levels | 128.03 mg/dL | Standard Deviation 102.36 |
| Physical Activity Coaching (Walk On!) | Triglycerides Levels | 116.2 mg/dL | Standard Deviation 61.36 |
Comparison: Covariated included in the as-treated adjusted linear regression analyses 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 sitep-value: 0.83Regression, Linear