Trial Outcomes & Findings for Scripps Wired for Health Monitoring Study (NCT NCT01975428)
NCT ID: NCT01975428
Last Updated: 2023-04-21
Results Overview
Multidimensional Health Locus of Control (Form C). Measure of the source of reinforcements for health-related behaviors: primarily internal, a matter of chance, or under the control of doctors, or other people. The scale includes 18 questions where responders indicate they strongly disagree(1), moderately disagree(2) slightly disagree(3) slightly agree(4) moderately agree(5) or strongly agree(6). Questions can be found here: https://nursing.vanderbilt.edu/projects/wallstonk/form\_c.php. Subscale measures are summed over responses: questions 1, 6, 8, 12, 13, \& 17 measure feeling of internal control (range 6-36); questions 2, 4, 9, 11, 15, 16 measure feeling of chance (range 6-36); questions 3, 5, 14 measure control of doctors (range 3-18); \& questions 7, 10, \& 18 measure control of others (range 3-18). Higher scores represent greater agreement with the questions that generally indicate greater feelings of more chance in one's health. Results presented using the 'Chance' subscale below.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
182 participants
Primary outcome timeframe
Measure at Day 180.
Results posted on
2023-04-21
Participant Flow
Participant milestones
| Measure |
Control
Disease Management Program
This program involves periodic calls from a Health Comp staff member to see how a participant was feeling and if they were having any health problems.
|
DM Pgm + Device
This program involves periodic calls from a Health Comp staff member to see how a participant was feeling and if they were having any health problems.
iBGStar - iPhone enabled capillary blood glucose meter plus disease management program. Subjects test blood glucose up to 4 times per day, every day.
iBG Star Blood Glucose Monitor: Participants will measure their blood glucose up to 4 times per day, every day.
iphone enabled Alive Cor ECG monitor. Participants take an ECG reading only when symptomatic Alive Cor Portable ECG monitor: Portable electrocardiogram. Subjects will monitor their cardiac rhythms only when they have symptoms.
Withings BP monitor - iPhone enabled home blood pressure monitor. Subjects test their blood pressure 2 times per day, up to 3 days per week.
Withings Blood Pressure monitor: Home blood pressure monitor. Participants will measure their blood pressure 2 times per day up to 3 times per week.
|
|---|---|---|
|
Overall Study
STARTED
|
85
|
97
|
|
Overall Study
COMPLETED
|
65
|
83
|
|
Overall Study
NOT COMPLETED
|
20
|
14
|
Reasons for withdrawal
| Measure |
Control
Disease Management Program
This program involves periodic calls from a Health Comp staff member to see how a participant was feeling and if they were having any health problems.
|
DM Pgm + Device
This program involves periodic calls from a Health Comp staff member to see how a participant was feeling and if they were having any health problems.
iBGStar - iPhone enabled capillary blood glucose meter plus disease management program. Subjects test blood glucose up to 4 times per day, every day.
iBG Star Blood Glucose Monitor: Participants will measure their blood glucose up to 4 times per day, every day.
iphone enabled Alive Cor ECG monitor. Participants take an ECG reading only when symptomatic Alive Cor Portable ECG monitor: Portable electrocardiogram. Subjects will monitor their cardiac rhythms only when they have symptoms.
Withings BP monitor - iPhone enabled home blood pressure monitor. Subjects test their blood pressure 2 times per day, up to 3 days per week.
Withings Blood Pressure monitor: Home blood pressure monitor. Participants will measure their blood pressure 2 times per day up to 3 times per week.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
17
|
4
|
|
Overall Study
Withdrawal by Subject
|
3
|
10
|
Baseline Characteristics
Scripps Wired for Health Monitoring Study
Baseline characteristics by cohort
| Measure |
Control
n=85 Participants
All study participants, including participants randomized to the control arm, were enrolled in the HealthComp disease management program, which involved outreach by HealthComp nursing staff for purposes of relaying medical education and wellness information with regard to disease prevention and chronic disease management.
|
DM Pgm + Device
n=97 Participants
All study participants, including participants randomized to the control arm, were enrolled in the HealthComp disease management program, which involved outreach by HealthComp nursing staff for purposes of relaying medical education and wellness information with regard to disease prevention and chronic disease management.
iBGStar - iPhone enabled capillary blood glucose meter plus disease management program. Subjects test blood glucose up to 4 times per day, every day.
iBG Star Blood Glucose Monitor: Participants will measure their blood glucose up to 4 times per day, every day.
iphone enabled Alive Cor ECG monitor. Participants take an ECG reading only when symptomatic Alive Cor Portable ECG monitor: Portable electrocardiogram. Subjects will monitor their cardiac rhythms only when they have symptoms.
Withings BP monitor - iPhone enabled home blood pressure monitor. Subjects test their blood pressure 2 times per day, up to 3 days per week.
Withings Blood Pressure monitor: Home blood pressure monitor. Participants will measure their blood pressure 2 times per day up to 3 times per week.
|
Total
n=182 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
75 Participants
n=93 Participants
|
80 Participants
n=4 Participants
|
155 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 9.8 • n=93 Participants
|
56.0 years
STANDARD_DEVIATION 9.0 • n=4 Participants
|
55.0 years
STANDARD_DEVIATION 9.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=93 Participants
|
63 Participants
n=4 Participants
|
112 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
70 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=93 Participants
|
86 Participants
n=4 Participants
|
162 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
62 Participants
n=93 Participants
|
73 Participants
n=4 Participants
|
135 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
85 participants
n=93 Participants
|
97 participants
n=4 Participants
|
182 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Measure at Day 180.Multidimensional Health Locus of Control (Form C). Measure of the source of reinforcements for health-related behaviors: primarily internal, a matter of chance, or under the control of doctors, or other people. The scale includes 18 questions where responders indicate they strongly disagree(1), moderately disagree(2) slightly disagree(3) slightly agree(4) moderately agree(5) or strongly agree(6). Questions can be found here: https://nursing.vanderbilt.edu/projects/wallstonk/form\_c.php. Subscale measures are summed over responses: questions 1, 6, 8, 12, 13, \& 17 measure feeling of internal control (range 6-36); questions 2, 4, 9, 11, 15, 16 measure feeling of chance (range 6-36); questions 3, 5, 14 measure control of doctors (range 3-18); \& questions 7, 10, \& 18 measure control of others (range 3-18). Higher scores represent greater agreement with the questions that generally indicate greater feelings of more chance in one's health. Results presented using the 'Chance' subscale below.
Outcome measures
| Measure |
Control
n=65 Participants
Disease Management Program
This program involves periodic calls from a Health Comp staff member to see how a participant was feeling and if they were having any health problems.
|
DM Pgm + Device
n=65 Participants
This program involves periodic calls from a Health Comp staff member to see how a participant was feeling and if they were having any health problems.
iBGStar - iPhone enabled capillary blood glucose meter plus disease management program. Subjects test blood glucose up to 4 times per day, every day.
iBG Star Blood Glucose Monitor: Participants will measure their blood glucose up to 4 times per day, every day.
iphone enabled Alive Cor ECG monitor. Participants take an ECG reading only when symptomatic Alive Cor Portable ECG monitor: Portable electrocardiogram. Subjects will monitor their cardiac rhythms only when they have symptoms.
Withings BP monitor - iPhone enabled home blood pressure monitor. Subjects test their blood pressure 2 times per day, up to 3 days per week.
Withings Blood Pressure monitor: Home blood pressure monitor. Participants will measure their blood pressure 2 times per day up to 3 times per week.
|
|---|---|---|
|
Participant Perceptions of Utility of Monitoring
|
13.4 Score on a scale
Standard Deviation 5.8
|
11.3 Score on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Total billed over 180 days.Total health care utilization and costs in USD.
Outcome measures
| Measure |
Control
n=65 Participants
Disease Management Program
This program involves periodic calls from a Health Comp staff member to see how a participant was feeling and if they were having any health problems.
|
DM Pgm + Device
n=83 Participants
This program involves periodic calls from a Health Comp staff member to see how a participant was feeling and if they were having any health problems.
iBGStar - iPhone enabled capillary blood glucose meter plus disease management program. Subjects test blood glucose up to 4 times per day, every day.
iBG Star Blood Glucose Monitor: Participants will measure their blood glucose up to 4 times per day, every day.
iphone enabled Alive Cor ECG monitor. Participants take an ECG reading only when symptomatic Alive Cor Portable ECG monitor: Portable electrocardiogram. Subjects will monitor their cardiac rhythms only when they have symptoms.
Withings BP monitor - iPhone enabled home blood pressure monitor. Subjects test their blood pressure 2 times per day, up to 3 days per week.
Withings Blood Pressure monitor: Home blood pressure monitor. Participants will measure their blood pressure 2 times per day up to 3 times per week.
|
|---|---|---|
|
Total Health Care Utilization and Costs.
|
5596 Units on a scale
Standard Deviation 22187
|
6026 Units on a scale
Standard Deviation 21426
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DM Pgm + Device
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
Eric J. Topol, M.D.
Scripps Translational Science Institute
Phone: 858-554-5708
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place