The Hope App: An Immersive Telehealth Solution for Older Adults With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- change in glycemic control
研究概览
简要总结
This research study will test how a computer program (called the Hope App) teaches diabetes care skills for older adults with diabetes. The study will compare those who receive diabetes education (10 educational modules and monthly health coaching) through the research program with those who receive care as usual.
详细描述
The Hope App offers a simple, high-impact, engaging, and immersive telehealth experience with the potential to become a ubiquitous diabetes management tool to transform diabetes patients into high performing drivers of their own care.
The research team aims to scale the platform, develop features that are important to aging adults, and run a clinical trial to validate the Hope App's health benefits.
- Specific Aim 1: Develop the Hope App's state-of-the-art immersive patient engagement experience with automated onboarding, social networking and gamified DSME/S features to support long-term patient retention. In doing so, usability testing will be performed to ensure patient-facing features on the platform and patient-facing content and curriculum materials are functioning and well received by participants.
- Specific Aim 2: Develop the Hope App's predictive analytic capabilities for population health management.
- Specific Aim 3: Conduct a clinical validation trial of the Hope App intervention on six-month clinical outcomes (Hemoglobin A1c), patient reported outcomes (diabetes distress) and engagement outcomes (patient retention, adherence to self-care behaviors).
The research team intends to deliver a scalable Hope App platform with a usable patient engagement portal designed for older adults and achieve decreases in blood glucose levels (HbA1c) and depressive burden, and sustained patient engagement.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 65 years and above
- •diagnosis of type 2 diabetes
- •English-speaking
- •baseline blood sugar value (HbA1c) of 7.5%
- •Internet access
排除标准
- •aged less than 65 years
- •non English-speaking
- •unable to provide informed consent
- •diagnosis of type 1 diabetes
- •unable to use a computer or mobile device
- •medical condition for which participation is contraindicated (dialysis, pregnancy, use of insulin pump)
结局指标
主要结局
change in glycemic control
时间窗: baseline and 6 months
change in HbA1c values recorded from point-of-care tests or in the electronic health record at visits. A mean change of 0.5% will be the a priori determined clinically meaningful minimum improvement from baseline to 6 months.
次要结局
- changes in self-reported diabetes distress(baseline to 3 months; 3 months to 6 months; baseline to 6 months)
- self-reported weight change(baseline to 3 months; 3 months to 6 months; baseline to 6 months)
- changes in participant engagement(baseline to 3 months; 3 months to 6 months; baseline to 6 months)
- changes in coping skills(baseline to 3 months; 3 months to 6 months; baseline to 6 months)
- changes in self-management adherence(baseline to 3 months; 3 months to 6 months; baseline to 6 months)
- changes in medication adherence scale(baseline to 3 months; 3 months to 6 months; baseline to 6 months)
- changes in depressive burden symptoms(baseline to 3 months; 3 months to 6 months; baseline to 6 months)
- changes in general anxiety symptoms(baseline to 3 months; 3 months to 6 months; baseline to 6 months)
- changes in perceived support from healthcare providers(baseline to 3 months; 3 months to 6 months; baseline to 6 months)
- changes in perceived competence(baseline to 3 months; 3 months to 6 months; baseline to 6 months)
- changes in perceived diabetes self-efficacy(baseline to 3 months; 3 months to 6 months; baseline to 6 months)