Gather mHealth India RCT for Behavior and Health Outcomes

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Gather app

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 Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gather app; Use of the Gather mHealth diabetes management system	Other: Gather app; 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.
No Intervention: Control; 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?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in HbA1c	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in HbA1c	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure		6 months
BMI		6 months
BMI		3 months
Blood pressure		3 months
Waist Circumference		3 months
Waist Circumference		6 Months
Fasting Blood Glucose		6 Months
Lipids		6 Months
Diabetes Self-care activities		6 Months
Self-efficacy	Stanford scale	6 Months
Diabetes Knowledge	Adaptation of RAND measure	6 Months
Medication Adherence	Visual Analog Scale	6 Months
Blood Glucose Testing Adherence	Visual Analog Scale	6 Months
Treatment Satisfaction	Adapted RAND measure	6 Months
Diabetes Distress	PAID-5	6 Months
mHealth intervention satisfaction	Investigator generated	6 Months
Fasting Blood Glucose		3 months
Lipids		3 months
Diabetes Self-care activities		3 months
Self-efficacy	Stanford Scale	3 months
Diabetes knowledge	Adapted RAND measure	3 months
Med Adherence	Visual Analog Scale	3 months
BG Testing Adherence	Visual Analog Scale	3 months
Treatment Satisfaction	Adapted RAND measure	3 months
Diabetes Distress	PAID-5	3 months
mHealth intervention satisfaction	Investigator generated	3 months

Collaborators and Investigators

• Sponsor: Gather Health India
• Collaborators: M.V. Hospital for Diabetes; DHL Innovation Center, India; Diabetes Action Centre
• Investigators: Principal Investigator: Sanjiv Shah, MD, Diabetes Action Centre

Publications and helpful links

General Publications

• Kleinman NJ, Shah A, Shah S, Phatak S, Viswanathan V. Improved Medication Adherence and Frequency of Blood Glucose Self-Testing Using an m-Health Platform Versus Usual Care in a Multisite Randomized Clinical Trial Among People with Type 2 Diabetes in India. Telemed J E Health. 2017 Sep;23(9):733-740. doi: 10.1089/tmj.2016.0265. Epub 2017 Mar 6.
• Kleinman NJ, Shah A, Shah S, Phatak S, Viswanathan V. Impact of the Gather mHealth System on A1C: Primary Results of a Multisite Randomized Clinical Trial Among People With Type 2 Diabetes in India. Diabetes Care. 2016 Oct;39(10):e169-70. doi: 10.2337/dc16-0869. Epub 2016 Aug 4. No abstract available.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 22, 2015
• First Submitted That Met QC Criteria: October 26, 2015
• First Posted (Estimate): October 27, 2015

Study Record Updates

• Last Update Posted (Estimate): January 22, 2016
• Last Update Submitted That Met QC Criteria: January 20, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Telemedicine; Glucose control; Randomized Controlled Trial; mHealth
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Gather mHealth 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: posted to clinicaltrials.gov