Trial Outcomes & Findings for Evaluating Increasing Physical Activity After Acute Coronary Syndrome (NCT NCT02531022)
NCT ID: NCT02531022
Last Updated: 2019-07-11
Results Overview
The primary outcome variable is the change in mean daily step count from the baseline period to the maintenance period (weeks 9-16).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
105 participants
Primary outcome timeframe
Baseline and end of Maintenance Period at Week 16
Results posted on
2019-07-11
Participant Flow
Participant milestones
| Measure |
Standard Exercise/Control
Participants were given standard exercise recommendations that are given to all patients based on the federal guidelines. They also monitored their step counts using a wearable device and received daily feedback.
|
Daily Feedback With Financial Incentive
Participants were given standard exercise recommendations that are given to all patients based on the federal guidelines. They also monitored their step counts using a wearable device, received daily feedback and were eligible for a financial incentive if their goals were achieved.
Daily feedback: Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns Financial incentive: A daily financial incentive framed as a loss of $2 each day goal is not achieved
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
50
|
|
Overall Study
COMPLETED
|
55
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating Increasing Physical Activity After Acute Coronary Syndrome
Baseline characteristics by cohort
| Measure |
Control
n=55 Participants
Participants were given standard exercise recommendations that are given to all patients based on the federal guidelines. They also monitored their step counts using a wearable device and received daily feedback.
|
Intervention
n=50 Participants
Participants were given standard exercise recommendations that are given to all patients based on the federal guidelines. They also monitored their step counts using a wearable device, received daily feedback and were eligible for a financial incentive if their goals were achieved.
Daily feedback: Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns Financial incentive: A daily financial incentive framed as a loss of $2 each day goal is not achieved
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
60 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
59.5 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White non-Hispanic
|
38 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black non-Hispanic
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Education
Some high school
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Education
High school graduate
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Education
Some college or specialized training
|
18 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Education
College graduate
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Education
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Marital Status
Single
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Marital Status
Married
|
35 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Marital Status
Other
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Insurance
Private
|
28 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Insurance
Medicare
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Insurance
Medicaid
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Insurance
Military
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Annual household income
Less than $50,000
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Annual household income
$50,000 to $100,000
|
17 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Annual household income
Greater than $100,000
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Annual household income
Missing
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Baseline step count
|
6577 steps
STANDARD_DEVIATION 3084 • n=5 Participants
|
7205 steps
STANDARD_DEVIATION 3246 • n=7 Participants
|
6876 steps
STANDARD_DEVIATION 3163 • n=5 Participants
|
|
Body Mass Index
|
30.1 kg/m^2
STANDARD_DEVIATION 5.6 • n=5 Participants
|
31.0 kg/m^2
STANDARD_DEVIATION 6.8 • n=7 Participants
|
30.6 kg/m^2
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Diabetes mellitus
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ejection fraction
|
57.8 Percentage of blood
STANDARD_DEVIATION 9.2 • n=5 Participants
|
58.2 Percentage of blood
STANDARD_DEVIATION 9.6 • n=7 Participants
|
58.0 Percentage of blood
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
MacNew Heart Disease Health-related Quality of Life questionnaire
|
2.7 Units on a scale (7 point scale)
STANDARD_DEVIATION 1.0 • n=5 Participants
|
2.5 Units on a scale (7 point scale)
STANDARD_DEVIATION 0.8 • n=7 Participants
|
2.6 Units on a scale (7 point scale)
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Hypertension
|
44 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Hyperlipidemia
|
45 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Previous cardiac catheterization
|
37 Days
n=5 Participants
|
35 Days
n=7 Participants
|
36 Days
n=5 Participants
|
|
Previous cardiac catheterization within 90 days preceding enrollment
|
40 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Smoking
Past smoker
|
28 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Smoking
Active smoker
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Valvular heart disease
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and end of Maintenance Period at Week 16The primary outcome variable is the change in mean daily step count from the baseline period to the maintenance period (weeks 9-16).
Outcome measures
| Measure |
Control
n=55 Participants
Participants will be given standard exercise recommendations that are given to all patients based on the federal guidelines. They will monitor their step counts using a wearable device and receive daily feedback.
Daily feedback: Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns
|
Intervention
n=50 Participants
Participants will be given a wearable device to monitor daily step counts with automated daily feedback on goal attainment via text message or email. A baseline step count will be calculated for each participant (weeks 1-2) and then they will be given a daily step goal with an increase of 15 percentage point each week during the 8-week ramp-up period (weeks 3-10) with a maximum goal of 10,000 steps. Then they'll be asked to maintain that step count (maintenance period). During the ramp-up and maintenance period they'll have a financial incentive of $14 allocated each week and $2 taken away each day the goal is not achieved. They'll be followed up for 8 weeks without incentives
Financial incentive: A daily financial incentive framed as a loss of $2 each day goal is not acheived
Daily feedback: Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns
|
|---|---|---|
|
Change in Mean Daily Steps
|
264 Steps
Interval 95.0 to 433.0
|
1501 Steps
Interval 1280.0 to 1722.0
|
SECONDARY outcome
Timeframe: Baseline and end of Follow Up Period at week 24Secondary outcomes include change in mean daily steps from the baseline period to the follow-up period (weeks 17-24).
Outcome measures
| Measure |
Control
n=55 Participants
Participants will be given standard exercise recommendations that are given to all patients based on the federal guidelines. They will monitor their step counts using a wearable device and receive daily feedback.
Daily feedback: Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns
|
Intervention
n=50 Participants
Participants will be given a wearable device to monitor daily step counts with automated daily feedback on goal attainment via text message or email. A baseline step count will be calculated for each participant (weeks 1-2) and then they will be given a daily step goal with an increase of 15 percentage point each week during the 8-week ramp-up period (weeks 3-10) with a maximum goal of 10,000 steps. Then they'll be asked to maintain that step count (maintenance period). During the ramp-up and maintenance period they'll have a financial incentive of $14 allocated each week and $2 taken away each day the goal is not achieved. They'll be followed up for 8 weeks without incentives
Financial incentive: A daily financial incentive framed as a loss of $2 each day goal is not acheived
Daily feedback: Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns
|
|---|---|---|
|
Change in Mean Daily Steps From Baseline to Follow-up Period
|
92 Steps
Interval -236.0 to 420.0
|
1066 Steps
Interval 885.0 to 1247.0
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Mitesh S. Patel
Perelman School of Medicine, University of Pennsylvania
Phone: 215-898-3367
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place