NCT02587286已完成不适用
Investigation of the Gather mHealth Platform on Diabetics' Behavior and Health Outcomes.
Gather Health India0 个研究点目标入组 91 人开始时间: 2015年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 主要终点
- Change in HbA1c
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Change in HbA1c
时间窗: 6 months
次要结局
- Change in HbA1c(3 months)
研究者
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