Evaluate the Value of Telehomecare for Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 2
- 主要终点
- Glucose control (HbA1c levels)
研究概览
简要总结
This is a mixed methods study that evaluates the effectiveness of the BlueStar app and its implementation in 3 hospital/health system sites across Ontario. The 6 month study includes 300 participants that are randomized to an immediate treatment group or a delayed intervention group. The primary outcomes include changes in HbA1c and patient reported outcomes and experience measures. Qualitative interviews with various stakeholders will explore issues relating to successful implementation.
详细描述
Background
BlueStar is a smart-phone enabled application that is designed to serve as a virtual coach for patients. The app sends daily evidence-based, real-time messages as well as longitudinal feedback on how to improve diabetes management. Benefits have been demonstrated in time periods as brief as three months. One US based study showed a decrease in hospitalizations and emergency department visits among participants who use the application. The BlueStar application is the first application in the USA to be given FDA approval as a Mobile Prescription Therapy. There is a need to explore the effectiveness, utility and cost of the intervention in context of Canadian healthcare, before it can be scaled across the system.
This study is based on a model of "integrated knowledge translation", where the knowledge users of the study have been central to the development of the research project from the very beginning. By using this integrated knowledge translation strategy, this study is far more likely to demonstrate impact in health system policy and decision-making.
Research Objective:
The primary objective is to determine if a smart-phone based application designed to improve diabetes self-management and experience of care among patients with Type II diabetes improves clinical outcomes, patient experience and health system costs compared to the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults, 18 years or older, currently being treated for Type II diabetes
- •HgbA1C greater or equal to 8.0% and at least 1.0% above target within the last 3 months
- •Have a functional email address or be willing to obtain one
- •Be functional in reading the English language (self reported)
排除标准
- •Have Type I diabetes or Latent autoimmune diabetes of adults (LADA)
- •Are on continuous glucose monitoring
- •Have an insulin pump
- •Are on dialysis
- •Are pregnant.
- •Are unable to use a computer or mobile phone due to severe mental or physical impairment
研究组 & 干预措施
Immediate Treatment Group
The Immediate Treatment group will receive access to the study intervention - BlueStar app, immediately after consenting for a total duration of 6 months.
干预措施: BlueStar app (Device)
Delayed Treatment Group
The Delayed Treatment group will receive access to the study intervention - BlueStar app, 3 months after consenting for a total duration of 3 months.
干预措施: BlueStar app (Device)
结局指标
主要结局
Glucose control (HbA1c levels)
时间窗: Baseline, 3 months and 6 months
Change in HbA1c from baseline to 6 months
次要结局
- Patient reported health outcomes and utilization - ER visit(Baseline, 3 months and 6 months)
- Patient reported health outcomes and utilization - Hospitalizations(Baseline, 3 months and 6 months)
- Patient reported health outcomes and utilization - Hypoglycemic episodes(Baseline, 3 months and 6 months)
- Patient reported health outcomes and utilization - Physician visits(Baseline, 3 months and 6 months)
- Patient reported health outcomes and utilization - Med Adherence(Baseline, 3 months and 6 months)
- Patient reported health outcomes and utilization - Blood glucose monitoring(Baseline, 3 months and 6 months)
- An adapted version of the Mobile App Rating Scale will collected from all participants(After 3 or 6 months on the app.)
- Standardized PROMs/PREMs(Baseline, 3 months and 6 months for all participants)
- Health system utilization data collected using Institute for Clinical and Evaluative Sciences (ICES).(12 to 18 months)
- App utilization data - time of use(Through study completion, an average of 3 or 6 months)
- App utilization data - Frequency of use(Through study completion, an average of 3 or 6 months)