Gather mHealth India RCT for Behavior and Health Outcomes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Gather app

• Registration Number: NCT02587286
• Lead Sponsor: Gather Health India

Brief Summary

The purpose of this trial is to explore the impact of the Gather Health diabetes management platform diabetics' health behaviors and health outcomes and how providers and diabetics interact with the Gather Health platform.

Detailed Description

The overall aim of the study is to estimate the impact of the Gather Health diabetes management platform on HbA1c, glycemic control, patient behavior, and physical and psychosocial measures. Additionally, this study will investigate patient and provider satisfaction with the platform.

Primary Objective:

Estimate the impact of the Gather Health diabetes management platform on HbA1c among diabetics in 3 cities in India.

Secondary Objective:

1. Estimate the impact of the Gather Health diabetes management platform on medication adherence, blood glucose (BG) control, body mass index (BMI), blood pressure (BP), and other behavior and health measures among diabetics in 3 cities in India.

2. Estimate patient and provider's satisfaction with the platform and the perceived usability and time spent on the platform

3. Generate ideas for future changes to the platform to make it more effective and user-friendly

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-10-22
• Study First Submitted QC: 2015-10-26
• Study First Posted: 2015-10-27
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-20
• Last Update Posted: 2016-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• Type 2 diabetes mellitus, diagnosis for > 6 months.
• Age 18-65, participants of either gender- males or females.
• HbA1c between 7.5% and 12.5% within last 6 months (inclusive).
• On stable diabetes therapy for >3 months prior to enrollment.
• Own an Android Smartphone.
• Participant willing to sign and date written Informed Consent Form to participate in the study.
• Willing to comply with the study schedule and procedures including randomization.

Exclusion Criteria

• Previously used Gather Health
• Currently using an insulin pump or continuous glucose monitor.
• Pregnant or planning to become pregnant in the next 12 months.
• Severe hearing or visual impairment.
• Active substance, alcohol, or drug abuser (sober <1 year).
• Any psychiatric illness including psychosis or schizophrenia that will impair the patient's ability to complete the study or follow study protocol.
• Recent major surgery or planning to have major surgery
• Significant renal, hepatic, or other disease that may impair patient's ability to complete the study or follow study protocol
• Using glucocorticoids
• Patients who have received or are planning to receive an organ transplant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gather app	Gather app	Use of the Gather mHealth diabetes management system

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	6 months

Secondary Outcome Measures

Name	Time	Method
Change in HbA1c	3 months