Trial Outcomes & Findings for Walk On! Physical Activity Coaching (NCT NCT02478359)

NCT ID: NCT02478359

Last Updated: 2020-02-19

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 2707 participants
• Primary outcome timeframe: 12 months following randomization
• Results posted on: 2020-02-19

Participant Flow

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.

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.

Participant milestones

Measure	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	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.
Overall Study STARTED	1349	1358
Overall Study Intention-to-treat Population Month 12	1243	1293
Overall Study COMPLETED	1243	1293
Overall Study NOT COMPLETED	106	65

Reasons for withdrawal

Measure	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	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.
Overall Study Disenrolled from health plan	106	65

Baseline Characteristics

Baseline values were not available on EMR for all participants.

Baseline characteristics by cohort

Measure	Standard Care n=1349 Participants 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!) n=1358 Participants 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.	Total n=2707 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=1349 Participants	0 Participants n=1358 Participants	0 Participants n=2707 Participants
Age, Categorical Between 18 and 65 years	300 Participants n=1349 Participants	305 Participants n=1358 Participants	605 Participants n=2707 Participants
Age, Categorical >=65 years	1049 Participants n=1349 Participants	1053 Participants n=1358 Participants	2102 Participants n=2707 Participants
Age, Continuous	72.4 years STANDARD_DEVIATION 10.14 • n=1349 Participants	72.4 years STANDARD_DEVIATION 10.24 • n=1358 Participants	72.4 years STANDARD_DEVIATION 10.19 • n=2707 Participants
Sex: Female, Male Female	739 Participants n=1349 Participants	716 Participants n=1358 Participants	1455 Participants n=2707 Participants
Sex: Female, Male Male	610 Participants n=1349 Participants	642 Participants n=1358 Participants	1252 Participants n=2707 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=1349 Participants	4 Participants n=1358 Participants	8 Participants n=2707 Participants
Race (NIH/OMB) Asian	59 Participants n=1349 Participants	81 Participants n=1358 Participants	140 Participants n=2707 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	6 Participants n=1349 Participants	13 Participants n=1358 Participants	19 Participants n=2707 Participants
Race (NIH/OMB) Black or African American	188 Participants n=1349 Participants	187 Participants n=1358 Participants	375 Participants n=2707 Participants
Race (NIH/OMB) White	1021 Participants n=1349 Participants	989 Participants n=1358 Participants	2010 Participants n=2707 Participants
Race (NIH/OMB) More than one race	4 Participants n=1349 Participants	3 Participants n=1358 Participants	7 Participants n=2707 Participants
Race (NIH/OMB) Unknown or Not Reported	67 Participants n=1349 Participants	81 Participants n=1358 Participants	148 Participants n=2707 Participants
Region of Enrollment United States	1349 participants n=1349 Participants	1358 participants n=1358 Participants	2707 participants n=2707 Participants
Smoking Status Never	162 Participants n=1349 Participants	169 Participants n=1358 Participants	331 Participants n=2707 Participants
Smoking Status Former	933 Participants n=1349 Participants	935 Participants n=1358 Participants	1868 Participants n=2707 Participants
Smoking Status Current	243 Participants n=1349 Participants	238 Participants n=1358 Participants	481 Participants n=2707 Participants
Smoking Status Unknown	11 Participants n=1349 Participants	16 Participants n=1358 Participants	27 Participants n=2707 Participants
Body mass Index (BMI)	27 kg/m^2 STANDARD_DEVIATION 6 • n=1349 Participants	27.1 kg/m^2 STANDARD_DEVIATION 5.9 • n=1358 Participants	27.1 kg/m^2 STANDARD_DEVIATION 5.9 • n=2707 Participants
Pulmonary Rehabilitation (up to past 3 years)	82 Participants n=1349 Participants	87 Participants n=1358 Participants	169 Participants n=2707 Participants
Spirometry - FEV1 % Predicted	60 % STANDARD_DEVIATION 21.9 • n=996 Participants • Baseline values were not available on EMR for all participants.	62.1 % STANDARD_DEVIATION 23.1 • n=1040 Participants • Baseline values were not available on EMR for all participants.	61.0 % STANDARD_DEVIATION 22.5 • n=2036 Participants • Baseline values were not available on EMR for all participants.
Spirometry - FEV1/FVC ratio	54.8 Ratio (X100) STANDARD_DEVIATION 14.7 • n=996 Participants • Baseline values were not available on EMR for all participants.	55.4 Ratio (X100) STANDARD_DEVIATION 13.9 • n=1040 Participants • Baseline values were not available on EMR for all participants.	55.1 Ratio (X100) STANDARD_DEVIATION 14.3 • n=2036 Participants • Baseline values were not available on EMR for all participants.
Charlson Comorbidity Index score Score 0-2	506 Participants n=1349 Participants	516 Participants n=1358 Participants	1022 Participants n=2707 Participants
Charlson Comorbidity Index score Score 3	210 Participants n=1349 Participants	231 Participants n=1358 Participants	441 Participants n=2707 Participants
Charlson Comorbidity Index score Score 4-5	348 Participants n=1349 Participants	332 Participants n=1358 Participants	680 Participants n=2707 Participants
Charlson Comorbidity Index score Score 6+	285 Participants n=1349 Participants	279 Participants n=1358 Participants	564 Participants n=2707 Participants
Comorbidity Heart Failture	398 Participants n=1349 Participants	407 Participants n=1358 Participants	805 Participants n=2707 Participants
Comorbidity Pulmonary Hypertension	70 Participants n=1349 Participants	73 Participants n=1358 Participants	143 Participants n=2707 Participants
Comorbidity Diabetes	456 Participants n=1349 Participants	417 Participants n=1358 Participants	873 Participants n=2707 Participants
Comorbidity Depression	361 Participants n=1349 Participants	380 Participants n=1358 Participants	741 Participants n=2707 Participants
Comorbidity Anxiety	383 Participants n=1349 Participants	359 Participants n=1358 Participants	742 Participants n=2707 Participants
Comorbidity Chronic Pain	273 Participants n=1349 Participants	272 Participants n=1358 Participants	545 Participants n=2707 Participants
Medication Long-lasting beta-agonists (LABA)	846 Participants n=1349 Participants	800 Participants n=1358 Participants	1646 Participants n=2707 Participants
Medication Long-lasting anticholinergic (LAMA)	702 Participants n=1349 Participants	720 Participants n=1358 Participants	1422 Participants n=2707 Participants
Medication Long-term systemic corticosteroids	131 Participants n=1349 Participants	112 Participants n=1358 Participants	243 Participants n=2707 Participants
Medication Oxygen-use	550 Participants n=1349 Participants	509 Participants n=1358 Participants	1059 Participants n=2707 Participants
Medication Inhaled corticosteroids (ICS)	1094 Participants n=1349 Participants	1053 Participants n=1358 Participants	2147 Participants n=2707 Participants
Medication LAMA & ICS	631 Participants n=1349 Participants	613 Participants n=1358 Participants	1244 Participants n=2707 Participants
Medication LABA & ICS	844 Participants n=1349 Participants	797 Participants n=1358 Participants	1641 Participants n=2707 Participants
All Cause Acute Care Utilization in the 12-months Prior to Randomization Hospitalizations	735 Participants n=1349 Participants	702 Participants n=1358 Participants	1437 Participants n=2707 Participants
All Cause Acute Care Utilization in the 12-months Prior to Randomization Observation stay	394 Participants n=1349 Participants	392 Participants n=1358 Participants	786 Participants n=2707 Participants
All Cause Acute Care Utilization in the 12-months Prior to Randomization Emergency department visits	1050 Participants n=1349 Participants	1039 Participants n=1358 Participants	2089 Participants n=2707 Participants
COPD-Related Acute Care Utilization in the 12-months Prior to Randomization Hospitalization	568 Participants n=1349 Participants	539 Participants n=1358 Participants	1107 Participants n=2707 Participants
COPD-Related Acute Care Utilization in the 12-months Prior to Randomization Observation Stays	243 Participants n=1349 Participants	237 Participants n=1358 Participants	480 Participants n=2707 Participants
COPD-Related Acute Care Utilization in the 12-months Prior to Randomization Emergency department visits	766 Participants n=1349 Participants	765 Participants n=1358 Participants	1531 Participants n=2707 Participants
COPD-Related Acute Care Utilization in the 12-months Prior to Randomization Outpatient treated COPD exacerbations	966 Participants n=1349 Participants	936 Participants n=1358 Participants	1902 Participants n=2707 Participants

PRIMARY outcome

Timeframe: 12 months following randomization

Population: ITT population

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

Outcome measures

Measure	Standard Care n=1349 Participants 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!) n=1358 Participants The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.
Number of Participants With All-cause Hospitalizations, Emergency Department (ED) Visits, Observation Stays, and Deaths	864 Participants	883 Participants

SECONDARY outcome

Timeframe: 12 months following randomization

Population: ITT population

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

Outcome measures

Measure	Standard Care n=1349 Participants 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!) n=1358 Participants The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.
Number of Deaths Among Participants	117 Participants	117 Participants

SECONDARY outcome

Timeframe: 12 months following randomization

Population: ITT population

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

Outcome measures

Measure	Standard Care n=1349 Participants 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!) n=1358 Participants The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.
Number of Participants With All-cause Hospitalizations	499 Participants	502 Participants

SECONDARY outcome

Timeframe: 12 months following randomization

Population: ITT population

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

Outcome measures

Measure	Standard Care n=1349 Participants 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!) n=1358 Participants The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.
Number of Participants With All-cause Emergency Department Visits	694 Participants	702 Participants

SECONDARY outcome

Timeframe: 12 months following randomization

Population: ITT population

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

Outcome measures

Measure	Standard Care n=1349 Participants 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!) n=1358 Participants The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.
Number of Participants With All-cause Observation Stays	269 Participants	295 Participants

SECONDARY outcome

Timeframe: 12 months following randomization

Population: ITT Population

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

Outcome measures

Measure	Standard Care n=1349 Participants 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!) n=1358 Participants The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.
Number of Participants With COPD-Related Hospitalizations, ED Visits, and Observation Stays	398 Participants	411 Participants

SECONDARY outcome

Timeframe: 12 months following randomization

Population: ITT population

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

Outcome measures

Measure	Standard Care n=1349 Participants 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!) n=1358 Participants The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.
Number of Participants With COPD Exacerbation	706 Participants	689 Participants

SECONDARY outcome

Timeframe: 12 months

Population: As treated population who completed the survey

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.

Outcome measures

Measure	Standard Care n=171 Participants 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!) n=188 Participants 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.
COPD Assessment Test, CAT - 12 Months Baseline	20.5 score on a scale Standard Deviation 8.47	18.0 score on a scale Standard Deviation 7.28
COPD Assessment Test, CAT - 12 Months 12 months	19.9 score on a scale Standard Deviation 8.03	17.8 score on a scale Standard Deviation 7.48
COPD Assessment Test, CAT - 12 Months Change at 12 months from baseline	-0.56 score on a scale Standard Deviation 6.46	-0.15 score on a scale Standard Deviation 6.22

SECONDARY outcome

Timeframe: 12 months

Population: ITT population

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.

Outcome measures

Measure	Standard Care n=1349 Participants 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!) n=1358 Participants 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.
Physical Activity Inactive (0 mins/wk) Baseline	890 Participants	911 Participants
Physical Activity Inactive (0 mins/wk) 12 Months	819 Participants	808 Participants
Physical Activity Insufficiently Active (1-149 mins/wk) Baseline	262 Participants	245 Participants
Physical Activity Insufficiently Active (1-149 mins/wk) 12 Months	243 Participants	268 Participants
Physical Activity Active (>=150 mins/wk) Baseline	160 Participants	174 Participants
Physical Activity Active (>=150 mins/wk) 12 Months	171 Participants	182 Participants

SECONDARY outcome

Timeframe: 12 months

Population: As treated population who completed the survey

The reported mean change between the baseline and 12 Months scores. Score range is 0-24. A negative change score indicates less depressive symptoms.

Outcome measures

Measure	Standard Care n=164 Participants 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!) n=183 Participants 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.
Personal Health Questionnaire, PHQ8 - 12 Months Baseline	6.6 score on a scale Standard Deviation 6.00	4.9 score on a scale Standard Deviation 4.22
Personal Health Questionnaire, PHQ8 - 12 Months 12 months	6.3 score on a scale Standard Deviation 5.40	4.8 score on a scale Standard Deviation 4.10
Personal Health Questionnaire, PHQ8 - 12 Months Change at 12 months from Baseline	-0.30 score on a scale Standard Deviation 4.66	-0.06 score on a scale Standard Deviation 3.90

SECONDARY outcome

Timeframe: 12 months

Population: As treated population who completed the survey

The reported mean change between the baseline and 12 Months scores. Score range is 0-21. A negative change score indicates less anxiety.

Outcome measures

Measure	Standard Care n=164 Participants 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!) n=184 Participants 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.
General Anxiety Disorder, GAD-7 - 12 Months Baseline	5.2 score on a scale Standard Deviation 5.81	4.0 score on a scale Standard Deviation 4.05
General Anxiety Disorder, GAD-7 - 12 Months 12 months	4.5 score on a scale Standard Deviation 5.08	3.8 score on a scale Standard Deviation 4.25
General Anxiety Disorder, GAD-7 - 12 Months Changes at 12 months from Baseline	-0.63 score on a scale Standard Deviation 4.44	-0.21 score on a scale Standard Deviation 3.63

SECONDARY outcome

Timeframe: 12 months

Population: As treated population who completed the survey

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.

Outcome measures

Measure	Standard Care n=172 Participants 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!) n=189 Participants 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.
PROMIS-10 HRQL , Physical Health - 12 Months Baseline	39.8 score on a scale Standard Deviation 8.62	40.7 score on a scale Standard Deviation 6.95
PROMIS-10 HRQL , Physical Health - 12 Months 12 months	40.3 score on a scale Standard Deviation 8.06	41.7 score on a scale Standard Deviation 7.18
PROMIS-10 HRQL , Physical Health - 12 Months Change at 12 months from Baseline	0.49 score on a scale Standard Deviation 6.72	0.97 score on a scale Standard Deviation 5.99

SECONDARY outcome

Timeframe: 12 months

Population: As treated population who completed the survey

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.

Outcome measures

Measure	Standard Care n=172 Participants 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!) n=189 Participants 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.
PROMIS-10 HRQL , Mental Health - 12 Months Baseline	45.3 score on a scale Standard Deviation 8.94	47.7 score on a scale Standard Deviation 8.80
PROMIS-10 HRQL , Mental Health - 12 Months 12 months	46.0 score on a scale Standard Deviation 8.65	47.9 score on a scale Standard Deviation 8.04
PROMIS-10 HRQL , Mental Health - 12 Months Changes at 12 months from Baseline	0.69 score on a scale Standard Deviation 7.39	0.26 score on a scale Standard Deviation 6.77

SECONDARY outcome

Timeframe: 12 months following randomization

Population: ITT population

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.

Outcome measures

Measure	Standard Care n=1127 Participants 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!) n=1186 Participants 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.
Diastolic Blood Pressure	70.5 mmHg Standard Deviation 9.59	70.1 mmHg Standard Deviation 9.63

SECONDARY outcome

Timeframe: 12 months following randomization

Population: ITT population

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.

Outcome measures

Measure	Standard Care n=1127 Participants 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!) n=1186 Participants 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.
Systolic Blood Pressure	130.8 mmHg Standard Deviation 14.54	130.7 mmHg Standard Deviation 14.19

SECONDARY outcome

Timeframe: 12 months following randomization

Population: ITT population

HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization

Outcome measures

Measure	Standard Care n=412 Participants 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!) n=383 Participants 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.
HbA1c Levels	7.1 percentage of glycosylated hemoglobin, Standard Deviation 1.45	7.2 percentage of glycosylated hemoglobin, Standard Deviation 1.36

SECONDARY outcome

Timeframe: 12 months following randomization

Population: ITT population

Cholesterol levels were obtained from values closest to the 12 months post randomization

Outcome measures

Measure	Standard Care n=593 Participants 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!) n=647 Participants 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.
LDL Levels	91.0 mg/dL Standard Deviation 36.96	86.6 mg/dL Standard Deviation 32.51

SECONDARY outcome

Timeframe: 12 months following randomization

Population: ITT population

Cholesterol levels were obtained from values closest to the 12 months post randomization

Outcome measures

Measure	Standard Care n=620 Participants 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!) n=671 Participants 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.
HDL Levels	54.3 mg/dL Standard Deviation 18.28	53.1 mg/dL Standard Deviation 17.60

SECONDARY outcome

Timeframe: 12 months following randomization

Population: ITT population

Cholesterol levels were obtained from values closest to the 12 months post randomization

Outcome measures

Measure	Standard Care n=621 Participants 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!) n=673 Participants 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.
Total Cholesterol Levels	168.8 mg/dL Standard Deviation 44.91	162.3 mg/dL Standard Deviation 41.82

SECONDARY outcome

Timeframe: 12 months post randomization

Population: ITT population

Cholesterol levels were obtained from values closest to the 12 months post randomization

Outcome measures

Measure	Standard Care n=372 Participants 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!) n=429 Participants 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.
Triglycerides Levels	128.3 mg/dL Standard Deviation 102.36	119.0 mg/dL Standard Deviation 65.60

SECONDARY outcome

Timeframe: 12 months following randomization

Population: ITT population

Body mass index measurements were based on values closest to the 12 months post randomization

Outcome measures

Measure	Standard Care n=1281 Participants 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!) n=1302 Participants 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.
Body Mass Index	26.9 kg/m^2 Standard Deviation 5.94	27.07 kg/m^2 Standard Deviation 5.90

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 to 12 months following randomization

Population: As-treated population

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.

Outcome measures

Measure	Standard Care n=1310 Participants 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!) n=321 Participants The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.
Number of Participants With All-cause Hospitalization, Emergency Department (ED) Visits, Observation Stays and Deaths	781 Participants	185 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 to 12 months following randomization

Population: As-treated population

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.

Outcome measures

Measure	Standard Care n=1310 Participants 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!) n=321 Participants The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.
Number of Deaths Among Participants	95 Participants	13 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 to 12 months following randomization

Population: As-treated population

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.

Outcome measures

Measure	Standard Care n=1310 Participants 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!) n=321 Participants The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.
Number of Participants With All-cause Hospitalizations	433 Participants	91 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 to 12 months following randomization

Population: As-treated population

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.

Outcome measures

Measure	Standard Care n=1310 Participants 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!) n=321 Participants The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.
Number of Participants With All-cause Emergency Department Visits	610 Participants	144 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 to 12 months following randomization

Population: As-treated population

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.

Outcome measures

Measure	Standard Care n=1310 Participants 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!) n=321 Participants The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.
Number of Participants With All-cause Observation Stays	230 Participants	53 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 to 12 months randomization

Population: As-treated population

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.

Outcome measures

Measure	Standard Care n=1310 Participants 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!) n=321 Participants The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.
Number of Participants With COPD-Related Hospitalizations, ED Visits, and Observation Stays	195 Participants	48 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6-12 months following randomization

Population: As-treated Walk On population

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.

Outcome measures

Measure	Standard Care n=1127 Participants 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!) n=300 Participants 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.
Diastolic Blood Pressure	70.5 mmHg Standard Deviation 9.59	69.6 mmHg Standard Deviation 8.85

OTHER_PRE_SPECIFIED outcome

Timeframe: 6-12 months following randomization

Population: As-treated Walk On population

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.

Outcome measures

Measure	Standard Care n=1127 Participants 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!) n=300 Participants 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.
Systolic Blood Pressure	130.8 mmHg Standard Deviation 14.54	128.8 mmHg Standard Deviation 13.02

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: As-treated Walk On population

HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization

Outcome measures

Measure	Standard Care n=412 Participants 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!) n=97 Participants 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.
HbA1c Levels	7.1 percentage of glycosylated hemoglobin Standard Deviation 1.45	7.2 percentage of glycosylated hemoglobin Standard Deviation 1.40

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: As-treated Walk On population

Cholesterol levels were obtained from values closest to the 12 months post randomization

Outcome measures

Measure	Standard Care n=593 Participants 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!) n=174 Participants 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.
LDL Levels	91.0 mg/dL Standard Deviation 36.96	85.8 mg/dL Standard Deviation 29.92

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: As-treated Walk On population

Cholesterol levels were obtained from values closest to the 12 months post randomization

Outcome measures

Measure	Standard Care n=620 Participants 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!) n=178 Participants 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.
HDL Levels	54.3 mg/dL Standard Deviation 18.28	52.8 mg/dL Standard Deviation 16.55

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: As-treated Walk On population

Cholesterol levels were obtained from values closest to the 12 months post randomization

Outcome measures

Measure	Standard Care n=621 Participants 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!) n=178 Participants 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.
Total Cholesterol Levels	168.8 md/dL Standard Deviation 44.91	161.4 md/dL Standard Deviation 38.31

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: As-treated Walk On population

Cholesterol levels were obtained from values closest to the 12 months post randomization

Outcome measures

Measure	Standard Care n=372 Participants 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!) n=114 Participants 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.
Triglycerides Levels	128.03 mg/dL Standard Deviation 102.36	116.2 mg/dL Standard Deviation 61.36

Adverse Events

Standard Care

Serious events: 499 serious events

Other events: 963 other events

Deaths: 117 deaths

Physical Activity Coaching (Walk On!)

Serious events: 502 serious events

Other events: 997 other events

Deaths: 117 deaths

Serious adverse events

Measure	Standard Care n=1349 participants at risk 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!) n=1358 participants at risk 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.
Investigations All-cause hospitalizations	37.0% 499/1349 • Number of events 499 • 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.	37.0% 502/1358 • Number of events 502 • 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.

Other adverse events

Measure	Standard Care n=1349 participants at risk 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!) n=1358 participants at risk 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.
Investigations Observational Stays	19.9% 269/1349 • Number of events 269 • 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.	21.7% 295/1358 • Number of events 295 • 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.
Investigations Emergency Department Visits	51.4% 694/1349 • Number of events 694 • 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.	51.7% 702/1358 • Number of events 702 • 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.

Additional Information

Huong Q2 Nguyen, Research Scientist

Kaiser Permanente

Phone: 626-564-3935

Email: huong.q2.nguyen@kp.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place