Gather mHealth India RCT for Behavior and Health Outcomes

Study Overview
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Brief Summary
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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
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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: 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. Estimate patient and provider's satisfaction with the platform and the perceived usability and time spent on the platform Generate ideas for future changes to the platform to make it more effective and user-friendly

Official Title
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Investigation of the Gather mHealth Platform on Diabetics' Behavior and Health Outcomes.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Gather app


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gather app<br>Use of the Gather mHealth diabetes management system | Other: Gather app<br>* Participants in the intervention group will receive the Gather Health software free for the duration of the study. Their medication and BG testing goals will be entered into the system and they will receive automated reminders. Their data will be regularly reviewed by study staff and feedback provided.<br>|
| No Intervention: Control<br>Control group participants will be recruited from the same clinics and will also fit all study inclusion and exclusion criteria. Participants will be recommended to test their BG as per usual care in India. Providers will not contact control group participants between regular visits, though they will respond to queries directed at them in typical fashion. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mHealth, Telemedicine, Randomized Controlled Trial, Glucose control