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Scripps Wired for Health Monitoring Study

Scripps Wired for Health Monitoring Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01975428
Enrollment
182
Registered
2013-11-04
Start date
2012-11-30
Completion date
2014-12-31
Last updated
2023-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrhythmia, Diabetes, Hypertension

Brief summary

People with chronic diseases such as diabetes, hypertension (high blood pressure) and cardiac (heart) arrhythmias tend to go to the doctor more often and have more tests done than those without those diseases. This can lead to increasing costs of healthcare and extra visits to doctors and healthcare facilities. There are now medical devices that can be used at home to monitor blood sugar, blood pressure, heart rhythms as well as other measurements. There have been some studies which show that when people take their own health readings, they are better able to control their disease, stay healthier and go to the doctor less often. In order to participate in the study participants will have been diagnosed with 1 or more of the following: Diabetes, Hypertension, Cardiac Arrhythmias. This study is designed to test those devices and see if they can help participants stay healthier through the recording and tracking of health measurements. Investigators will also be testing how easy it is to use these devices and whether or how easy it is to fit them in their daily schedule. Participants will be given an iPhone for use during the study and their recordings will be stored and displayed on the phone.

Detailed description

The study will evaluate the impact of a Wireless Monitoring intervention for chronically ill individuals with diabetes, hypertension, and arrhythmias. This project utilizes the concept of 'hot-spotting' in that investigators will aim to target individuals with the highest health care needs, which investigators have defined to be patients with these diagnoses who showed the highest health care utilization rates over the previous 12-month period based on reimbursement data from a large health care third party administrator. Investigators aim to determine if wireless monitoring can reduce health care service utilization and thus health care costs for the small number of patients who spend the greatest number of health care dollars, thereby cutting the overall amount of health care spending dramatically. Furthermore, investigators will be assessing whether or not access to health measurement data and the possibility of receiving feedback from a study staff member will increase the compliance of patients to their medication regimen, recommended diet and exercise. It is anticipated that armed with their own health data, these patients will be less likely to need acute care visits Study participants will be employees of Scripps Health or dependents of employees covered with Scripps insurance, administered by third-party administrator, Health Comp. In addition, patients will be currently enrolled or willing to enroll in Health Comp's Disease Management program. Investigators predict that in addition to participation in the program, wireless monitoring will be associated with decreased inpatient health service utilization (hospital admissions, days of hospitalization) and decreased outpatient health service utilization (emergency department visits, need-based primary care clinic visits, and need-based specialty clinic visits). Investigators predict that these decreases will translate into significant reductions in health care costs for the treatment group relative to a control group and relative to pre-monitoring utilization rates.

Interventions

DEVICEDM Pgm + device

Disease management program plus a device corresponding to an individual's disease(s): iBGStar - iPhone enabled capillary blood glucose meter. Subjects test blood glucose up to 4 times per day, every day. Withings BP monitor - iPhone enabled home blood pressure monitor. Subjects test their blood pressure 2 times per day, up to 3 days per week. iPhone enabled Alive Cor ECG monitor. Participants take an ECG reading only when symptomatic.

BEHAVIORALControl

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.

Sponsors

Scripps Health
CollaboratorOTHER
Scripps Translational Science Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Scripps Health insured employee or adult family member 2. Internet access and e-mail 3. Provide permission for study staff to access medical records 4. Participating in Health Comp Disease Management program or willingness to join 5. English speaking 6. Within the past 12 months, a history of billing insurance for diagnostic codes consistent with diabetes, hypertension, and/or cardiac arrhythmia 7. 18 years and older 8. Willingness to use wireless devices and study iPhone

Exclusion criteria

1. Employee of Scripps Clinic Medical Group 2. Related to or household sharing with another study participant (if there are two people or more in one household that are eligible, the member that has the highest utilization will be invited to join first) 3. Unwilling or unable to grant informed consent 4. Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Participant Perceptions of Utility of MonitoringMeasure 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.

Secondary

MeasureTime frameDescription
Total Health Care Utilization and Costs.Total billed over 180 days.Total health care utilization and costs in USD.

Countries

United States

Participant flow

Participants by arm

ArmCount
Control
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.
85
DM Pgm + Device
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.
97
Total182

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up174
Overall StudyWithdrawal by Subject310

Baseline characteristics

CharacteristicControlDM Pgm + DeviceTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
10 Participants17 Participants27 Participants
Age, Categorical
Between 18 and 65 years
75 Participants80 Participants155 Participants
Age, Continuous54.5 years
STANDARD_DEVIATION 9.8
56.0 years
STANDARD_DEVIATION 9
55.0 years
STANDARD_DEVIATION 9.4
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants10 Participants14 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
76 Participants86 Participants162 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
5 Participants1 Participants6 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Asian
9 Participants6 Participants15 Participants
Race (NIH/OMB)
Black or African American
4 Participants6 Participants10 Participants
Race (NIH/OMB)
More than one race
4 Participants10 Participants14 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants1 Participants6 Participants
Race (NIH/OMB)
White
62 Participants73 Participants135 Participants
Region of Enrollment
United States
85 participants97 participants182 participants
Sex: Female, Male
Female
49 Participants63 Participants112 Participants
Sex: Female, Male
Male
36 Participants34 Participants70 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 850 / 97
serious
Total, serious adverse events
0 / 850 / 97

Outcome results

Primary

Participant Perceptions of Utility of Monitoring

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.

Time frame: Measure at Day 180.

ArmMeasureValue (MEAN)Dispersion
ControlParticipant Perceptions of Utility of Monitoring13.4 Score on a scaleStandard Deviation 5.8
DM Pgm + DeviceParticipant Perceptions of Utility of Monitoring11.3 Score on a scaleStandard Deviation 5.3
Secondary

Total Health Care Utilization and Costs.

Total health care utilization and costs in USD.

Time frame: Total billed over 180 days.

ArmMeasureValue (MEAN)Dispersion
ControlTotal Health Care Utilization and Costs.5596 Units on a scaleStandard Deviation 22187
DM Pgm + DeviceTotal Health Care Utilization and Costs.6026 Units on a scaleStandard Deviation 21426

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026