Trial Outcomes & Findings for Gamification-Augmented Home-Based Exercise for Peripheral Artery Disease (NCT NCT04536012)
NCT ID: NCT04536012
Last Updated: 2025-02-04
Results Overview
Change in daily step count from baseline to the intervention period (main adjusted model)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
103 participants
Primary outcome timeframe
16 Weeks
Results posted on
2025-02-04
Participant Flow
Participant milestones
| Measure |
Control
Via the Way to Health platform, all patients will receive daily text messages that inform them of their previous day's step count for 24 weeks.
|
Intervention
Participants have a 4-week ramp-up towards their step goal and are asked to maintain the goal for the rest of the study. They receive daily texts informing them if they met their step goal and biweekly texts to encourage walking for exercise.
Participants are entered into a game. Each week they receive 70 points. If the step goal was met they keep their points. If not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level. If not, they drop a level. Participants start in the middle of 5 levels.
Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and partner to discuss ways they can help the participant meet their goal. Every 8 weeks, we have a follow up call if the participant is stuck in a lower level and restart them back at the middle level.
In the follow-up period, participants continue to get a daily text stating if they met their step goal.
Gamification and Social Incentives: Participants in the intervention arm will receive gamification and social incentives as part of the intervention. See arm descriptions for more detail.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
51
|
|
Overall Study
COMPLETED
|
51
|
45
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gamification-Augmented Home-Based Exercise for Peripheral Artery Disease
Baseline characteristics by cohort
| Measure |
Control
n=52 Participants
Via the Way to Health platform, all patients will receive daily text messages that inform them of their previous day's step count for 24 weeks.
|
Intervention
n=51 Participants
Participants have a 4-week ramp-up towards their step goal and are asked to maintain the goal for the rest of the study. They receive daily texts informing them if they met their step goal and biweekly texts to encourage walking for exercise.
Participants are entered into a game. Each week they receive 70 points. If the step goal was met they keep their points. If not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level. If not, they drop a level. Participants start in the middle of 5 levels.
Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and partner to discuss ways they can help the participant meet their goal. Every 8 weeks, we have a follow up call if the participant is stuck in a lower level and restart them back at the middle level.
In the follow-up period, participants continue to get a daily text stating if they met their step goal.
Gamification and Social Incentives: Participants in the intervention arm will receive gamification and social incentives as part of the intervention. See arm descriptions for more detail.
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
69.4 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
69.7 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
42 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Education
Some high school
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Education
High school graduate
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Education
Some college
|
11 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Education
College graduate
|
32 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Education
Some High School
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Education
High School Graduate
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Education
Some College
|
11 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Education
College Graduate
|
32 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Marital Status
Single
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Marital Status
Married
|
27 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Marital Status
Other
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Annual Household Income
< $50,000
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Annual Household Income
$50,000 to $100,000
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Annual Household Income
> $100,000
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Prior Use of Smartphone or Wearable to Track Steps
|
35 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Current Smoking
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Hypertension
|
37 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Hyperlipidemia
|
37 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Diabetes
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Prior MI
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Stroke
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Heart Failure
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
COPD
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Kidney Disease
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
San Diego Claudication Questionnaire
Classic Claudication
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
San Diego Claudication Questionnaire
Atypical Leg Pain
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
San Diego Claudication Questionnaire
No Symptoms
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Baseline Daily Step Count
|
4540 Steps
STANDARD_DEVIATION 2379 • n=5 Participants
|
4191 Steps
STANDARD_DEVIATION 1627 • n=7 Participants
|
4367 Steps
STANDARD_DEVIATION 2039 • n=5 Participants
|
|
Goal Step Increase
|
1160 Steps
STANDARD_DEVIATION 2033 • n=5 Participants
|
1549 Steps
STANDARD_DEVIATION 740 • n=7 Participants
|
1353 Steps
STANDARD_DEVIATION 1541 • n=5 Participants
|
|
BMI
|
29.4 kg/m^2
STANDARD_DEVIATION 7.2 • n=5 Participants
|
30.8 kg/m^2
STANDARD_DEVIATION 5.4 • n=7 Participants
|
30.1 kg/m^2
STANDARD_DEVIATION 6.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 16 WeeksChange in daily step count from baseline to the intervention period (main adjusted model)
Outcome measures
| Measure |
Control
n=52 Participants
Via the Way to Health platform, all patients will receive daily text messages that inform them of their previous day's step count for 24 weeks.
|
Intervention
n=51 Participants
Participants have a 4-week ramp-up towards their step goal and are asked to maintain the goal for the rest of the study. They receive daily texts informing them if they met their step goal and biweekly texts to encourage walking for exercise.
Participants are entered into a game. Each week they receive 70 points. If the step goal was met they keep their points. If not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level. If not, they drop a level. Participants start in the middle of 5 levels.
Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and partner to discuss ways they can help the participant meet their goal. Every 8 weeks, we have a follow up call if the participant is stuck in a lower level and restart them back at the middle level.
In the follow-up period, participants continue to get a daily text stating if they met their step goal.
Gamification and Social Incentives: Participants in the intervention arm will receive gamification and social incentives as part of the intervention. See arm descriptions for more detail.
|
|---|---|---|
|
Change in Daily Step Count
|
783 steps per day
Standard Deviation 2441
|
1770 steps per day
Standard Deviation 2481
|
SECONDARY outcome
Timeframe: 24 WeeksChange in daily step count from baseline to the follow-up period (main adjusted model)
Outcome measures
| Measure |
Control
n=52 Participants
Via the Way to Health platform, all patients will receive daily text messages that inform them of their previous day's step count for 24 weeks.
|
Intervention
n=51 Participants
Participants have a 4-week ramp-up towards their step goal and are asked to maintain the goal for the rest of the study. They receive daily texts informing them if they met their step goal and biweekly texts to encourage walking for exercise.
Participants are entered into a game. Each week they receive 70 points. If the step goal was met they keep their points. If not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level. If not, they drop a level. Participants start in the middle of 5 levels.
Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and partner to discuss ways they can help the participant meet their goal. Every 8 weeks, we have a follow up call if the participant is stuck in a lower level and restart them back at the middle level.
In the follow-up period, participants continue to get a daily text stating if they met their step goal.
Gamification and Social Incentives: Participants in the intervention arm will receive gamification and social incentives as part of the intervention. See arm descriptions for more detail.
|
|---|---|---|
|
Change in Daily Step Count
|
717 steps per day
Standard Deviation 2410
|
1786 steps per day
Standard Deviation 2476
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 WeeksChange in Walking Impairment Questionnaire score from baseline to the end of the intervention period, and from baseline to the end of the follow-up period. Participants are asked to rate the degree of difficulty of various physical activities, ranging from 0 (unable) to 4 (no difficulty). Scores are divided by the maximum number of points and presented on a scale of 0%-100% where 0% indicates they are unable to do the activity and 100% indicates they have no difficulty.
Outcome measures
| Measure |
Control
n=52 Participants
Via the Way to Health platform, all patients will receive daily text messages that inform them of their previous day's step count for 24 weeks.
|
Intervention
n=51 Participants
Participants have a 4-week ramp-up towards their step goal and are asked to maintain the goal for the rest of the study. They receive daily texts informing them if they met their step goal and biweekly texts to encourage walking for exercise.
Participants are entered into a game. Each week they receive 70 points. If the step goal was met they keep their points. If not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level. If not, they drop a level. Participants start in the middle of 5 levels.
Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and partner to discuss ways they can help the participant meet their goal. Every 8 weeks, we have a follow up call if the participant is stuck in a lower level and restart them back at the middle level.
In the follow-up period, participants continue to get a daily text stating if they met their step goal.
Gamification and Social Incentives: Participants in the intervention arm will receive gamification and social incentives as part of the intervention. See arm descriptions for more detail.
|
|---|---|---|
|
Change in Walking Impairment Questionnaire Score
WIQ Speed
|
1.7 units on a scale
Interval -5.0 to 8.5
|
4.8 units on a scale
Interval -2.3 to 11.8
|
|
Change in Walking Impairment Questionnaire Score
WIQ Distance
|
-3.8 units on a scale
Interval -12.2 to 4.5
|
7.3 units on a scale
Interval -1.5 to 16.0
|
|
Change in Walking Impairment Questionnaire Score
WIQ Stair Climbing
|
6.4 units on a scale
Interval -1.0 to 13.8
|
9.5 units on a scale
Interval 1.8 to 17.2
|
|
Change in Walking Impairment Questionnaire Score
WIQ Overall
|
1.4 units on a scale
Interval -5.0 to 7.8
|
5.7 units on a scale
Interval -3.5 to 15.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 WeeksChange in PROMIS (Patient-Reported Outcomes Measurement Information System) mobility, pain interference, and satisfaction with social roles and activities scores from baseline to the end of the intervention period, and from baseline to the end of the follow-up period. In the mobility survey, participants are asked to rate the level of difficulty of various physical activities on a scale from 1 to 5, where 1 means they are unable to do the activity and 5 means they have no difficulty. In the pain interference survey, they are asked to rate the degree to which pain interfered with various activities on a scale from 1 to 5, where 1 indicates pain did not interfere and 5 indicates pain very much interfered. For the satisfaction with social roles, participants are asked to rate how satisfied they are with their ability to perform various activities on a scale of 1-5, where 1 indicates they are not satisfied and 5 indicates they are very satisfied.
Outcome measures
| Measure |
Control
n=52 Participants
Via the Way to Health platform, all patients will receive daily text messages that inform them of their previous day's step count for 24 weeks.
|
Intervention
n=51 Participants
Participants have a 4-week ramp-up towards their step goal and are asked to maintain the goal for the rest of the study. They receive daily texts informing them if they met their step goal and biweekly texts to encourage walking for exercise.
Participants are entered into a game. Each week they receive 70 points. If the step goal was met they keep their points. If not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level. If not, they drop a level. Participants start in the middle of 5 levels.
Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and partner to discuss ways they can help the participant meet their goal. Every 8 weeks, we have a follow up call if the participant is stuck in a lower level and restart them back at the middle level.
In the follow-up period, participants continue to get a daily text stating if they met their step goal.
Gamification and Social Incentives: Participants in the intervention arm will receive gamification and social incentives as part of the intervention. See arm descriptions for more detail.
|
|---|---|---|
|
Change in PROMIS Mobility, Pain Interference, and Satisfaction With Social Roles and Activities Scores
PROMIS Pain
|
-2.2 units on a scale
Interval -4.5 to 0.2
|
-4.7 units on a scale
Interval -7.2 to -2.3
|
|
Change in PROMIS Mobility, Pain Interference, and Satisfaction With Social Roles and Activities Scores
PROMIS Social Function
|
-0.6 units on a scale
Interval -2.8 to 1.6
|
0.3 units on a scale
Interval -2.0 to 2.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 WeeksChange in SF-36 (36-Item Short Form Survey) physical functioning scale from baseline to the end of the intervention period, and from baseline to the end of the follow-up period. Participants are asked to self-report their health using 8 variously scaled scores. The scales are re-coded to values from 0 to 100, with 0 indicating lowest functioning/well-being and 100 indicating the highest.
Outcome measures
| Measure |
Control
n=52 Participants
Via the Way to Health platform, all patients will receive daily text messages that inform them of their previous day's step count for 24 weeks.
|
Intervention
n=51 Participants
Participants have a 4-week ramp-up towards their step goal and are asked to maintain the goal for the rest of the study. They receive daily texts informing them if they met their step goal and biweekly texts to encourage walking for exercise.
Participants are entered into a game. Each week they receive 70 points. If the step goal was met they keep their points. If not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level. If not, they drop a level. Participants start in the middle of 5 levels.
Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and partner to discuss ways they can help the participant meet their goal. Every 8 weeks, we have a follow up call if the participant is stuck in a lower level and restart them back at the middle level.
In the follow-up period, participants continue to get a daily text stating if they met their step goal.
Gamification and Social Incentives: Participants in the intervention arm will receive gamification and social incentives as part of the intervention. See arm descriptions for more detail.
|
|---|---|---|
|
Change in SF-36 Physical Functioning Scale
Physical functioning
|
0.3 units on a scale
Interval -4.4 to 5.0
|
6.7 units on a scale
Interval 1.8 to 11.6
|
|
Change in SF-36 Physical Functioning Scale
Role functioning/physical
|
5.9 units on a scale
Interval -3.9 to 15.6
|
12.8 units on a scale
Interval 2.6 to 23.0
|
|
Change in SF-36 Physical Functioning Scale
Role functioning/emotional
|
5.7 units on a scale
Interval -6.2 to 17.6
|
3.9 units on a scale
Interval -8.5 to 16.3
|
|
Change in SF-36 Physical Functioning Scale
Energy/fatigue
|
3 units on a scale
Interval -1.4 to 7.4
|
3 units on a scale
Interval -1.6 to 7.7
|
|
Change in SF-36 Physical Functioning Scale
Emotional well-being
|
0.9 units on a scale
Interval -3.3 to 5.0
|
2.4 units on a scale
Interval -1.9 to 6.7
|
|
Change in SF-36 Physical Functioning Scale
Social functioning
|
7.4 units on a scale
Interval -0.5 to 15.4
|
2 units on a scale
Interval -6.3 to 10.4
|
|
Change in SF-36 Physical Functioning Scale
Pain
|
3.5 units on a scale
Interval -2.2 to 9.2
|
10.5 units on a scale
Interval 4.5 to 16.4
|
|
Change in SF-36 Physical Functioning Scale
General Health
|
1.2 units on a scale
Interval -2.5 to 4.8
|
4.2 units on a scale
Interval 0.4 to 8.0
|
|
Change in SF-36 Physical Functioning Scale
Health Change
|
5.3 units on a scale
Interval -2.4 to 13.0
|
16.9 units on a scale
Interval 8.8 to 24.9
|
Adverse Events
Control
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Intervention
Serious events: 6 serious events
Other events: 21 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Control
n=52 participants at risk
Via the Way to Health platform, all patients will receive daily text messages that inform them of their previous day's step count for 24 weeks.
|
Intervention
n=51 participants at risk
Participants have a 4-week ramp-up towards their step goal and are asked to maintain the goal for the rest of the study. They receive daily texts informing them if they met their step goal and biweekly texts to encourage walking for exercise.
Participants are entered into a game. Each week they receive 70 points. If the step goal was met they keep their points. If not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level. If not, they drop a level. Participants start in the middle of 5 levels.
Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and partner to discuss ways they can help the participant meet their goal. Every 8 weeks, we have a follow up call if the participant is stuck in a lower level and restart them back at the middle level.
In the follow-up period, participants continue to get a daily text stating if they met their step goal.
Gamification and Social Incentives: Participants in the intervention arm will receive gamification and social incentives as part of the intervention. See arm descriptions for more detail.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Orthopedic
|
0.00%
0/52 • 24 weeks
Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.
|
9.8%
5/51 • 24 weeks
Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.
|
|
Cardiac disorders
Cardiovascular
|
1.9%
1/52 • 24 weeks
Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.
|
2.0%
1/51 • 24 weeks
Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.
|
|
Product Issues
Fitbit-related
|
0.00%
0/52 • 24 weeks
Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.
|
0.00%
0/51 • 24 weeks
Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.
|
|
General disorders
Other
|
3.8%
2/52 • 24 weeks
Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.
|
0.00%
0/51 • 24 weeks
Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.
|
Other adverse events
| Measure |
Control
n=52 participants at risk
Via the Way to Health platform, all patients will receive daily text messages that inform them of their previous day's step count for 24 weeks.
|
Intervention
n=51 participants at risk
Participants have a 4-week ramp-up towards their step goal and are asked to maintain the goal for the rest of the study. They receive daily texts informing them if they met their step goal and biweekly texts to encourage walking for exercise.
Participants are entered into a game. Each week they receive 70 points. If the step goal was met they keep their points. If not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level. If not, they drop a level. Participants start in the middle of 5 levels.
Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and partner to discuss ways they can help the participant meet their goal. Every 8 weeks, we have a follow up call if the participant is stuck in a lower level and restart them back at the middle level.
In the follow-up period, participants continue to get a daily text stating if they met their step goal.
Gamification and Social Incentives: Participants in the intervention arm will receive gamification and social incentives as part of the intervention. See arm descriptions for more detail.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Orthopedic
|
9.6%
5/52 • 24 weeks
Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.
|
15.7%
8/51 • 24 weeks
Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.
|
|
Cardiac disorders
Cardiovascular
|
1.9%
1/52 • 24 weeks
Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.
|
7.8%
4/51 • 24 weeks
Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.
|
|
Product Issues
Fitbit-related
|
5.8%
3/52 • 24 weeks
Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.
|
0.00%
0/51 • 24 weeks
Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.
|
|
General disorders
Other
|
15.4%
8/52 • 24 weeks
Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.
|
25.5%
13/51 • 24 weeks
Adverse events were collected via participant reports through study surveys at 16 weeks, and 24-weeks or participant reports to study staff through text, email or phone call.
|
Additional Information
Alexander C. Fanaroff, MD, MHS
Hospital of the University of Pennsylvania
Phone: 2156157674
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place