Gather mHealth India RCT for Behavior and Health Outcomes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02587286
• Other study ID #: Gather mHealth 1
• Status: Completed
• Phase: N/A
• First received: October 22, 2015
• Last updated: January 20, 2016
• Start date: March 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Gather Health India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India : Astha Independent Ethics CommitteeIndia : M.V. Diabetes Research Centre Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Gather Health India	DHL Innovation Center, India, Diabetes Action Centre, M.V. Hospital for Diabetes

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	BMI		6 months	No
Other	Blood pressure		6 months	No
Other	Waist Circumference		6 Months	No
Other	Fasting Blood Glucose		6 Months	No
Other	Lipids		6 Months	No
Other	Diabetes Self-care activities		6 Months	No
Other	Self-efficacy	Stanford scale	6 Months	No
Other	Diabetes Knowledge	Adaptation of RAND measure	6 Months	No
Other	Medication Adherence	Visual Analog Scale	6 Months	No
Other	Blood Glucose Testing Adherence	Visual Analog Scale	6 Months	No
Other	Treatment Satisfaction	Adapted RAND measure	6 Months	No
Other	Diabetes Distress	PAID-5	6 Months	No
Other	mHealth intervention satisfaction	Investigator generated	6 Months	No
Other	BMI		3 months	No
Other	Blood pressure		3 months	No
Other	Waist Circumference		3 months	No
Other	Fasting Blood Glucose		3 months	No
Other	Lipids		3 months	No
Other	Diabetes Self-care activities		3 months	No
Other	Self-efficacy	Stanford Scale	3 months	No
Other	Diabetes knowledge	Adapted RAND measure	3 months	No
Other	Med Adherence	Visual Analog Scale	3 months	No
Other	BG Testing Adherence	Visual Analog Scale	3 months	No
Other	Treatment Satisfaction	Adapted RAND measure	3 months	No
Other	Diabetes Distress	PAID-5	3 months	No
Other	mHealth intervention satisfaction	Investigator generated	3 months	No
Primary	Change in HbA1c		6 months	No
Secondary	Change in HbA1c		3 months	No