Evaluation of an mHealth Behavioural Intervention for the Self-Management for Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Change in HbA1c from baseline to 12 months
研究概览
简要总结
The purpose of this study is to evaluate a patient-centered diabetes self-management mobile application (app), which was developed with feedback from both patients and healthcare providers. During the 12 month randomized control trial, participants in the intervention group will be provided with a mobile phone and commercial home medical devices, such as a weight scale, glucometer and activity monitor. The measurements taken from the medical devices will wirelessly transfer to the mobile phone, where the app will assess the data and provide patients with actionable self-management knowledge. The proposed intervention may be helpful in increasing adherence to recommended self-care practices, improving self-efficacy, and enhancing the overall patient experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English-speaking individuals
- •Diagnosed with non-insulin requiring type 2 diabetes
- •Outpatients
- •Baseline A1c of 7.5% or higher
排除标准
- •Patients who are deemed unable to use a mobile phone (e.g. due to vision problems), and/or to comply with home monitoring (e.g. suffering from anxiety or depression)
- •Diabetes duration <1 year
结局指标
主要结局
Change in HbA1c from baseline to 12 months
时间窗: Baseline, 3, 6, 9 and 12 months
次要结局
- Diabetes Distress Scale(Baseline, 6 and 12 months)
- Blood pressure(Baseline, 3, 6, 9 and 12 months)
- Cholesterol (LDL and total)(Baseline, 6 and 12 months)
- Summary of Diabetes Self-Care Activities(Baseline, 6 and 12 months)
- Medication changes(3, 6, 9 and 12 months)
- Weight(Baseline, 3, 6, 9 and 12 months)
- Glycemic excursions(3, 6, 9 and 12 months)
- BMI(Baseline, 3, 6, 9 and 12 months)
- Diabetes Empowerment Scale(Baseline, 6 and 12 months)
研究者
Joseph Cafazzo
Senior Director
University Health Network, Toronto