Scripps Wired for Health Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01975428|
Recruitment Status : Completed
First Posted : November 4, 2013
Last Update Posted : May 20, 2015
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.
|Condition or disease||Intervention/treatment|
|Diabetes Hypertension Cardiac Arrhythmia||Device: Withings Blood Pressure monitor Device: iBG Star Blood Glucose Monitor Device: Alive Cor Portable ECG mopnitor Behavioral: Diese Management Program|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||161 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Scripps Wired for Health Study|
|Study Start Date :||November 2012|
|Primary Completion Date :||December 2014|
|Study Completion Date :||December 2014|
Disease Management program
|Behavioral: Diese Management Program|
Active Comparator: DM Pgm + glucometer
iBGStar - iPhone enabled capillary blood glucose meter plus disease management program. Subjects test blood glucose up to 4 times per day, every day.
Device: iBG Star Blood Glucose Monitor
Participants will measure their blood glucose up to 4 times per day, every day.Behavioral: Diese Management Program
Active Comparator: DM Pgm + Blood Pressure Monitor
Withings BP monitor - iPhone enabled home blood pressure monitor. Subjects test their blood pressure 2 times per day, up to 3 days per week.
Device: Withings Blood Pressure monitor
Home blood pressure monitor. Participants will measure their blood pressure 2 times per day up to 3 times per week.Behavioral: Diese Management Program
Active Comparator: DM pgm + Alive Cor ECG
Disease management program + iphone enabled Alive Cor ECG monitor. Participants take an ECG reading only when symptomatic
Device: Alive Cor Portable ECG mopnitor
Portable electrocardiogram. Subjects will monitor their cardiac rhythms only when they have symptoms.Behavioral: Diese Management Program
- Participant perceptions of utility of monitoring [ Time Frame: Change in perceptions from Day 1 to Day 180. ]As this is a pilot study, primary endpoints will include participant perceptions of the utility of monitoring.
- Change in health care utilization and costs [ Time Frame: Change from Day 1 to Day 180. ]Overall health care costs billed, as well as inpatient health service utilization (hospital admissions, days of hospitalization) and outpatient health service utilization (emergency department visits, need-based primary care clinic visits, and need-based specialty clinic visits). Investigators will also assess any increases/changes in medication use.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01975428
|United States, California|
|Scripps Translational Science Institute|
|La Jolla, California, United States, 92037|
|Principal Investigator:||Eric J Topol, MD||Scripps Translational Science Institute|