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Scripps Wired for Health Study

This study has been completed.
Sponsor:
Collaborator:
Scripps Health
Information provided by (Responsible Party):
Eric Topol, MD, Scripps Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01975428
First received: October 17, 2012
Last updated: May 19, 2015
Last verified: May 2015
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Scripps Wired for Health Study

Further study details as provided by Scripps Translational Science Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 161
Study Start Date: November 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01975428

Locations
United States, California
Scripps Translational Science Institute
La Jolla, California, United States, 92037
Sponsors and Collaborators
Scripps Translational Science Institute
Scripps Health
Investigators
Principal Investigator: Eric J Topol, MD Scripps Translational Science Institute
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eric Topol, MD, Director, Scripps Translational Science Institute, Scripps Translational Science Institute
ClinicalTrials.gov Identifier: NCT01975428     History of Changes
Other Study ID Numbers: Scripps WFH Study
Study First Received: October 17, 2012
Last Updated: May 19, 2015

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 28, 2017