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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | No Intervention | 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 | |
| Physical Activity Coaching (Walk On!) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Activity Coaching (Walk On!) | Behavioral | The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huong Q Nguyen, PhD, RN | Research Scientist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Southern California | Pasadena | California | 91101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26597414 | Background | 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. | |
| 30144938 |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-treat (ITT) population included all participants randomized into the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Physical Activity Coaching (Walk On!) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ITT population | Posted | Count of Participants | Participants | 12 months following randomization |
|
1 year
Adverse event monitoring focused on passive monitoring via the EMR, components of the primary composite outcome (all cause hospitalizations, observation stays, emergency department visits, and death) for all randomized patients. Only deaths are reported here as anticipated serious adverse events, not related to study procedures. All-cause acute care utilization events were also considered anticipated serious adverse events, not related to study procedures.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| All-cause hospitalizations | Investigations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Observational Stays | Investigations | Systematic Assessment |
It is important to note the low uptake/participation in the Walk On! intervention and its effects on the primary, intention to treat analyses, as well, the sub-optimal baseline and follow-up response rates to the patient-reported outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Huong Q2 Nguyen, Research Scientist | Kaiser Permanente | 626-564-3935 | huong.q2.nguyen@kp.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2018 | Feb 21, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| HbA1c Levels | HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization | 12 months following randomization |
| LDL Levels | Cholesterol levels were obtained from values closest to the 12 months post randomization | 12 months following randomization |
| HDL Levels | Cholesterol levels were obtained from values closest to the 12 months post randomization | 12 months following randomization |
| Total Cholesterol Levels | Cholesterol levels were obtained from values closest to the 12 months post randomization | 12 months following randomization |
| Triglycerides Levels | Cholesterol levels were obtained from values closest to the 12 months post randomization | 12 months post randomization |
| Body Mass Index | Body mass index measurements were based on values closest to the 12 months post randomization | 12 months following randomization |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 6-12 months following randomization |
| HbA1c Levels | HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization | 12 months |
| LDL Levels | Cholesterol levels were obtained from values closest to the 12 months post randomization | 12 months |
| HDL Levels | Cholesterol levels were obtained from values closest to the 12 months post randomization | 12 months |
| Total Cholesterol Levels | Cholesterol levels were obtained from values closest to the 12 months post randomization | 12 months |
| Triglycerides Levels | Cholesterol levels were obtained from values closest to the 12 months post randomization | 12 months |
| 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. |
| 31418811 | Derived | Nguyen HQ, Moy ML, Liu IA, Fan VS, Gould MK, Desai SA, Towner WJ, Yuen G, Lee JS, Park SJ, Xiang AH. Effect of Physical Activity Coaching on Acute Care and Survival Among Patients With Chronic Obstructive Pulmonary Disease: A Pragmatic Randomized Clinical Trial. JAMA Netw Open. 2019 Aug 2;2(8):e199657. doi: 10.1001/jamanetworkopen.2019.9657. |
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Smoking Status | Count of Participants | Participants |
|
| Body mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Pulmonary Rehabilitation (up to past 3 years) | Count of Participants | Participants |
|
| Spirometry - FEV1 % Predicted | Baseline values were not available on EMR for all participants. | Mean | Standard Deviation | % |
|
| Spirometry - FEV1/FVC ratio | Baseline values were not available on EMR for all participants. | Mean | Standard Deviation | Ratio (X100) |
|
| Charlson Comorbidity Index score | The total score in the CCI is derived by summing the assigned weights of all comorbid conditions presented by the client. Higher scores indicate a more severe condition and consequently, a worse prognosis | Count of Participants | Participants |
|
| Comorbidity | Count of Participants | Participants |
|
| Medication | Count of Participants | Participants |
|
| All Cause Acute Care Utilization in the 12-months Prior to Randomization | Count of Participants | Participants |
|
| COPD-Related Acute Care Utilization in the 12-months Prior to Randomization | Count of Participants | Participants |
|
| 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. |
|
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| 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 | ITT population | Posted | Count of Participants | Participants | 12 months following randomization |
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| 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 | ITT population | Posted | Count of Participants | Participants | 12 months following randomization |
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| 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 | ITT population | Posted | Count of Participants | Participants | 12 months following randomization |
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| 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 | ITT population | Posted | Count of Participants | Participants | 12 months following randomization |
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| 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 | ITT Population | Posted | Count of Participants | Participants | 12 months following randomization |
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| 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 | ITT population | Posted | Count of Participants | Participants | 12 months following randomization |
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| 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. | As treated population who completed the survey | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| 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. | ITT population | Posted | Count of Participants | Participants | 12 months |
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| 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. | As treated population who completed the survey | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| 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. | As treated population who completed the survey | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| 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. | As treated population who completed the survey | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| 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. | As treated population who completed the survey | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| 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. | ITT population | Posted | Mean | Standard Deviation | mmHg | 12 months following randomization |
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| 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. | ITT population | Posted | Mean | Standard Deviation | mmHg | 12 months following randomization |
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| Secondary | HbA1c Levels | HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization | ITT population | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin, | 12 months following randomization |
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| Secondary | LDL Levels | Cholesterol levels were obtained from values closest to the 12 months post randomization | ITT population | Posted | Mean | Standard Deviation | mg/dL | 12 months following randomization |
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| Secondary | HDL Levels | Cholesterol levels were obtained from values closest to the 12 months post randomization | ITT population | Posted | Mean | Standard Deviation | mg/dL | 12 months following randomization |
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| Secondary | Total Cholesterol Levels | Cholesterol levels were obtained from values closest to the 12 months post randomization | ITT population | Posted | Mean | Standard Deviation | mg/dL | 12 months following randomization |
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| Secondary | Triglycerides Levels | Cholesterol levels were obtained from values closest to the 12 months post randomization | ITT population | Posted | Mean | Standard Deviation | mg/dL | 12 months post randomization |
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| Secondary | Body Mass Index | Body mass index measurements were based on values closest to the 12 months post randomization | ITT population | Posted | Mean | Standard Deviation | kg/m^2 | 12 months following randomization |
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| 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. | As-treated population | Posted | Count of Participants | Participants | 2 to 12 months following randomization |
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| 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. | As-treated population | Posted | Count of Participants | Participants | 2 to 12 months following randomization |
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| 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. | As-treated population | Posted | Count of Participants | Participants | 2 to 12 months following randomization |
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| 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. | As-treated population | Posted | Count of Participants | Participants | 2 to 12 months following randomization |
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| 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. | As-treated population | Posted | Count of Participants | Participants | 2 to 12 months following randomization |
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| 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. | As-treated population | Posted | Count of Participants | Participants | 2 to 12 months randomization |
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| 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. | As-treated Walk On population | Posted | Mean | Standard Deviation | mmHg | 6-12 months following randomization |
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| 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. | As-treated Walk On population | Posted | Mean | Standard Deviation | mmHg | 6-12 months following randomization |
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| Other Pre-specified | HbA1c Levels | HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization | As-treated Walk On population | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | 12 months |
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| Other Pre-specified | LDL Levels | Cholesterol levels were obtained from values closest to the 12 months post randomization | As-treated Walk On population | Posted | Mean | Standard Deviation | mg/dL | 12 months |
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| Other Pre-specified | HDL Levels | Cholesterol levels were obtained from values closest to the 12 months post randomization | As-treated Walk On population | Posted | Mean | Standard Deviation | mg/dL | 12 months |
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| Other Pre-specified | Total Cholesterol Levels | Cholesterol levels were obtained from values closest to the 12 months post randomization | As-treated Walk On population | Posted | Mean | Standard Deviation | md/dL | 12 months |
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| Other Pre-specified | Triglycerides Levels | Cholesterol levels were obtained from values closest to the 12 months post randomization | As-treated Walk On population | Posted | Mean | Standard Deviation | mg/dL | 12 months |
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| 117 |
| 1,349 |
| 499 |
| 1,349 |
| 963 |
| 1,349 |
| EG001 | 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. | 117 | 1,358 | 502 | 1,358 | 997 | 1,358 |
| Emergency Department Visits | Investigations | Systematic Assessment |
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Not provided
Not provided
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Change at 12 months from baseline |
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| Insufficiently Active (1-149 mins/wk) Baseline |
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| Insufficiently Active (1-149 mins/wk) 12 Months |
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| Active (>=150 mins/wk) Baseline |
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| Active (>=150 mins/wk) 12 Months |
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| Change at 12 months from Baseline |
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| Changes at 12 months from Baseline |
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| Change at 12 months from Baseline |
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| Changes at 12 months from Baseline |
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