Scripps Wired for Health Study

• ClinicalTrials.gov Identifier: NCT01975428
• Recruitment Status: Completed
• First Posted: November 3, 2013
• Last Update Posted: May 20, 2015
• Sponsor: Scripps Translational Science Institute
• Collaborator: Scripps Health
• Information provided by (Responsible Party): Eric Topol, MD, Scripps Translational Science Institute

Tracking Information

• First Submitted Date: October 17, 2012
• First Posted Date: November 3, 2013
• Last Update Posted Date: May 20, 2015
• Study Start Date: November 2012
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 1, 2013)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 1, 2013)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Scripps Wired for Health Study
• Official Title: Scripps Wired for Health Study

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research

Condition

• Diabetes
• Hypertension
• Cardiac Arrhythmia

Intervention

• 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.
• Device: iBG Star Blood Glucose Monitor
  Participants will measure their blood glucose up to 4 times per day, every day.
• Device: Alive Cor Portable ECG mopnitor
  Portable electrocardiogram. Subjects will monitor their cardiac rhythms only when they have symptoms.
• Behavioral: Diese Management Program

Study Arms

• Control
  Disease Management program
  Intervention: 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.
  Interventions:

  • Device: iBG Star Blood Glucose Monitor
  • 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.
  Interventions:

  • Device: Withings Blood Pressure monitor
  • 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
  Interventions:

  • Device: Alive Cor Portable ECG mopnitor
  • Behavioral: Diese Management Program

• Publications *: Kim JY, Wineinger NE, Steinhubl SR. The Influence of Wireless Self-Monitoring Program on the Relationship Between Patient Activation and Health Behaviors, Medication Adherence, and Blood Pressure Levels in Hypertensive Patients: A Substudy of a Randomized Controlled Trial. J Med Internet Res. 2016 Jun 22;18(6):e116. doi: 10.2196/jmir.5429.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 19, 2015): 161
• Original Estimated Enrollment (submitted: November 1, 2013): 200
• Actual Study Completion Date: December 2014
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01975428
• Other Study ID Numbers: Scripps WFH Study
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Eric Topol, MD, Scripps Translational Science Institute
• Study Sponsor: Scripps Translational Science Institute
• Collaborators: Scripps Health

Investigators

• Principal Investigator: Eric J Topol, MD; Scripps Translational Science Institute

• PRS Account: Scripps Translational Science Institute
• Verification Date: May 2015