Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01975428 |
| Other study ID # |
Scripps WFH Study |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 2012 |
| Est. completion date |
December 2014 |
Study information
| Verified date |
April 2023 |
| Source |
Scripps Translational Science Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
