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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02757183
• Other study ID #: Pro-00041208-AP
• Status: Recruiting
• Phase: N/A
• First received: April 27, 2016
• Last updated: May 11, 2016
• Start date: April 2016
• Est. completion date: March 2017

Study information

• Verified date: May 2016
• Source: AnalyticsPlus, Inc.
• Contact: Ruchi Mathur, MD
• Phone: (310) 423-4295
• Email: Ruchi.mathur[@]cshs.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• "IntelliH"
"IntelliH" is a mobile health and a web-based software application that allows patients to enter their blood glucose, weight, medication, diet and other life-style data for review by their providers and monitor their health remotely.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
AnalyticsPlus, Inc.	Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Blood glucose range maintenance and variation	Frequency of hypoglycemic, hyperglycemic, and out of recommended range events	Six months	No
Secondary	Adherence to Prescribed Medication	Medication adherence rates will be measured for each medication used by patient	Six months	No