Do Patient-Centric mHealth Programs Improve Patient Engagement and Health Outcomes.

• Conditions: Diabetes

• Registration Number: NCT02757183
• Lead Sponsor: AnalyticsPlus, Inc.

Brief Summary

The "INTELLIH" (brand name of the mobile health application) Diabetes Study is to understand the usage of a mobile health application, IntelliH, and connected wireless devices such as glucometer by the diabetic patients and ascertain if there are any improvements in short-term health outcomes.

Detailed Description

The proposed pilot program is the first of its kind in the nation to use a product, "IntelliH" - Intelligent Health for All, that combines four key technologies in one platform: 1) Mobile health application (mHealth) App and web portal, 2) wireless sensors and wearable devices, 3) Secure text messaging when both sender and receiver are logged in to the system and video-based patient interaction, and 4) remote health monitoring. The purpose of this pilot program is to understand a) usage and adoption of these technologies by providers and patients, and b) document the short-term improvements in health outcomes in a diabetic population. This pilot study will follow 20 diabetic patients (Type 1 or Type 2) as they beta-test this system, and will acquire data on consented subjects over a period of six months.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-27
• Study First Submitted QC: 2016-04-27
• Status Verified: 2016-05
• Study First Posted: 2016-05-02
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-13
• Primary Completion: 2016-11
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• A1c greater than or equal to 6.5%.
• Age greater than or equal to 18 years.
• Ability to comply with study protocol.
• Available and usable internet facilities at home.
• Availability and usable smart phone.

Exclusion Criteria

-Inability to comply with instructions and directions.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Usage and Adoption of the smart phone based mobile health application	Six Months	Patients adoption will be assessed directly through the application and through questionnaire

Secondary Outcome Measures

Name	Time	Method
Adherence to Prescribed Medication	Six months	Medication adherence rates will be measured for each medication used by patient
Blood glucose range maintenance and variation	Six months	Frequency of hypoglycemic, hyperglycemic, and out of recommended range events

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States