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Gather mHealth India RCT for Behavior and Health Outcomes

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ClinicalTrials.gov Identifier: NCT02587286
Recruitment Status : Completed
First Posted : October 27, 2015
Last Update Posted : January 22, 2016
Sponsor:
Collaborators:
DHL Innovation Center, India
Diabetes Action Centre
M.V. Hospital for Diabetes
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Other: Gather app Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Investigation of the Gather mHealth Platform on Diabetics' Behavior and Health Outcomes.
Study Start Date : March 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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.



Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change in HbA1c [ Time Frame: 3 months ]

Other Outcome Measures:
  1. BMI [ Time Frame: 6 months ]
  2. Blood pressure [ Time Frame: 6 months ]
  3. Waist Circumference [ Time Frame: 6 Months ]
  4. Fasting Blood Glucose [ Time Frame: 6 Months ]
  5. Lipids [ Time Frame: 6 Months ]
  6. Diabetes Self-care activities [ Time Frame: 6 Months ]
  7. Self-efficacy [ Time Frame: 6 Months ]
    Stanford scale

  8. Diabetes Knowledge [ Time Frame: 6 Months ]
    Adaptation of RAND measure

  9. Medication Adherence [ Time Frame: 6 Months ]
    Visual Analog Scale

  10. Blood Glucose Testing Adherence [ Time Frame: 6 Months ]
    Visual Analog Scale

  11. Treatment Satisfaction [ Time Frame: 6 Months ]
    Adapted RAND measure

  12. Diabetes Distress [ Time Frame: 6 Months ]
    PAID-5

  13. mHealth intervention satisfaction [ Time Frame: 6 Months ]
    Investigator generated

  14. BMI [ Time Frame: 3 months ]
  15. Blood pressure [ Time Frame: 3 months ]
  16. Waist Circumference [ Time Frame: 3 months ]
  17. Fasting Blood Glucose [ Time Frame: 3 months ]
  18. Lipids [ Time Frame: 3 months ]
  19. Diabetes Self-care activities [ Time Frame: 3 months ]
  20. Self-efficacy [ Time Frame: 3 months ]
    Stanford Scale

  21. Diabetes knowledge [ Time Frame: 3 months ]
    Adapted RAND measure

  22. Med Adherence [ Time Frame: 3 months ]
    Visual Analog Scale

  23. BG Testing Adherence [ Time Frame: 3 months ]
    Visual Analog Scale

  24. Treatment Satisfaction [ Time Frame: 3 months ]
    Adapted RAND measure

  25. Diabetes Distress [ Time Frame: 3 months ]
    PAID-5

  26. mHealth intervention satisfaction [ Time Frame: 3 months ]
    Investigator generated



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02587286


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gather Health India
ClinicalTrials.gov Identifier: NCT02587286     History of Changes
Other Study ID Numbers: Gather mHealth 1
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: January 22, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: posted to clinicaltrials.gov

Keywords provided by Gather Health India:
mHealth
Telemedicine
Randomized Controlled Trial
Glucose control

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases