Scripps Wired for Health Study
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ClinicalTrials.gov Identifier: NCT01975428 |
Recruitment Status :
Completed
First Posted : November 3, 2013
Last Update Posted : May 20, 2015
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Tracking Information | ||||
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First Submitted Date ICMJE | October 17, 2012 | |||
First Posted Date ICMJE | November 3, 2013 | |||
Last Update Posted Date | May 20, 2015 | |||
Study Start Date ICMJE | November 2012 | |||
Actual Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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.
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Scripps Wired for Health Study | |||
Official Title ICMJE | 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. |
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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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Health Services Research |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
161 | |||
Original Estimated Enrollment ICMJE |
200 | |||
Actual Study Completion Date ICMJE | December 2014 | |||
Actual Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01975428 | |||
Other Study ID Numbers ICMJE | Scripps WFH Study | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Eric Topol, MD, Scripps Translational Science Institute | |||
Study Sponsor ICMJE | Scripps Translational Science Institute | |||
Collaborators ICMJE | Scripps Health | |||
Investigators ICMJE |
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PRS Account | Scripps Translational Science Institute | |||
Verification Date | May 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |