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

NCT ID: NCT02757183

Last Updated: 2016-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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Diabetes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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"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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cedars-Sinai Medical Center

OTHER

Sponsor Role collaborator

AnalyticsPlus, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ruchi Mathur, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

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Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ruchi Mathur, MD

Role: CONTACT

(310) 423-4295

Laura Sarmiento, CCRP

Role: CONTACT

(310) 423-4295

Other Identifiers

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Pro-00041208-AP

Identifier Type: -

Identifier Source: org_study_id

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