Back to resultsGather mHealth India RCT for Behavior and Health Outcomes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gather app
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring mHealth, Telemedicine, Randomized Controlled Trial, Glucose control
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Gather app
Control
Arm Description
Use of the Gather mHealth diabetes management system
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.
Outcomes
Primary Outcome Measures
Change in HbA1c
Secondary Outcome Measures
Change in HbA1c
Full Information
NCT ID
NCT02587286
First Posted
October 22, 2015
Last Updated
January 20, 2016
Sponsor
Gather Health India
Collaborators
DHL Innovation Center, India, Diabetes Action Centre, M.V. Hospital for Diabetes
1. Study Identification
Unique Protocol Identification Number
NCT02587286
Brief Title
Gather mHealth India RCT for Behavior and Health Outcomes
Official Title
Investigation of the Gather mHealth Platform on Diabetics' Behavior and Health Outcomes.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gather Health India
Collaborators
DHL Innovation Center, India, Diabetes Action Centre, M.V. Hospital for Diabetes
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
mHealth, Telemedicine, Randomized Controlled Trial, Glucose control
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gather app
Arm Type
Experimental
Arm Description
Use of the Gather mHealth diabetes management system
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Gather app
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in HbA1c
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in HbA1c
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
BMI
Time Frame
6 months
Title
Blood pressure
Time Frame
6 months
Title
Waist Circumference
Time Frame
6 Months
Title
Fasting Blood Glucose
Time Frame
6 Months
Title
Lipids
Time Frame
6 Months
Title
Diabetes Self-care activities
Time Frame
6 Months
Title
Self-efficacy
Description
Stanford scale
Time Frame
6 Months
Title
Diabetes Knowledge
Description
Adaptation of RAND measure
Time Frame
6 Months
Title
Medication Adherence
Description
Visual Analog Scale
Time Frame
6 Months
Title
Blood Glucose Testing Adherence
Description
Visual Analog Scale
Time Frame
6 Months
Title
Treatment Satisfaction
Description
Adapted RAND measure
Time Frame
6 Months
Title
Diabetes Distress
Description
PAID-5
Time Frame
6 Months
Title
mHealth intervention satisfaction
Description
Investigator generated
Time Frame
6 Months
Title
BMI
Time Frame
3 months
Title
Blood pressure
Time Frame
3 months
Title
Waist Circumference
Time Frame
3 months
Title
Fasting Blood Glucose
Time Frame
3 months
Title
Lipids
Time Frame
3 months
Title
Diabetes Self-care activities
Time Frame
3 months
Title
Self-efficacy
Description
Stanford Scale
Time Frame
3 months
Title
Diabetes knowledge
Description
Adapted RAND measure
Time Frame
3 months
Title
Med Adherence
Description
Visual Analog Scale
Time Frame
3 months
Title
BG Testing Adherence
Description
Visual Analog Scale
Time Frame
3 months
Title
Treatment Satisfaction
Description
Adapted RAND measure
Time Frame
3 months
Title
Diabetes Distress
Description
PAID-5
Time Frame
3 months
Title
mHealth intervention satisfaction
Description
Investigator generated
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjiv Shah, MD
Organizational Affiliation
Diabetes Action Centre
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
posted to clinicaltrials.gov
Citations:
PubMed Identifier
28328396
Citation
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.
Results Reference
derived
PubMed Identifier
27493133
Citation
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.
Results Reference
derived
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Gather mHealth India RCT for Behavior and Health Outcomes
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