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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes
• Intervention / Treatment: Device: "IntelliH"

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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study participants will be recruited from the list of diabetes patients coming to Cedars-Sinai Medical Center for their regular treatment. Several physicians will be involved in making this program available to their patients. Eligible and consenting patients will be recruited.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usage and Adoption of the smart phone based mobile health application	Patients adoption will be assessed directly through the application and through questionnaire	Six Months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AnalyticsPlus, Inc.
• Collaborators: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Ruchi Mathur, MD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): November 1, 2016
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: April 27, 2016
• First Submitted That Met QC Criteria: April 27, 2016
• First Posted (Estimate): May 2, 2016

Study Record Updates

• Last Update Posted (Estimate): May 13, 2016
• Last Update Submitted That Met QC Criteria: May 11, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: Pro-00041208-AP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED