EMPOWERing Patients With Chronic Diseases Through Smartphone App, Health Coaching and Shared Decision Making
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 320
- 试验地点
- 3
- 主要终点
- HbA1c
研究概览
简要总结
Chronic diseases are the leading cause of deaths in Singapore. The rising prevalence in chronic diseases with age and Singapore's rapidly aging population calls for new models of care to effectively prevent the onset and delay the progression of these diseases. Advancement in medical technology has offered new innovations that aid healthcare systems in coping with the rapid rising in healthcare needs. These include mobile applications, wearable technologies and machine learning-derived personalized behaviorial interventions. The overall goal of the project is to improve health outcomes in chronic disease patients through delivering targeted nudges via mobile application and wearable to sustain behavioral change. Our overall objective is to design, develop, and evaluate an adaptive intervention platform on wearable devices and shared decision-making during consultations for patients with diabetes and hypertension. Our aim for this study is to assess the clinical effectiveness of real-time personalized educational and behavioural interventions delivered through wearable (Fitbit) and an integrative mobile application in improving patient glycaemic control measured using HbA1c over 9 months. Secondary outcomes will include change in systolic blood pressure, quality of life (QoL), patient activation, medication adherence, physical activity level, diet, direct healthcare cost and indirect healthcare cost over 9 months. We will conduct a randomized controlled trial among patients with comorbid diabetes and hypertension. This proposal aims to develop sustainable and cost-effective behavioural change among patients with comorbid diabetes and hypertension through patient empowerment and targeted chronic disease care.
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
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 21 years old and above
- •Have been diagnosed with diabetes at time of recruitment
- •Most recent glycated haemoglobin (HbA1c) ≥ 7.0%
- •Systolic blood pressure≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg on two or more prior visits, physician-diagnosed hypertension, or on antihypertensive medication
- •Physically able to exercise
- •Literate in English
- •Agreeable to be monitored by EMPOWER and/or Fitbit apps
- •Able to conform to monitoring schedule
排除标准
- •On bolus insulin treatment
- •Require assistance with basic activities of daily living (BADL)
- •Have planned major operation or surgical procedure within next 9 months
- •Cognitively impaired (scored ≥ 6 on the Abbreviated Mental Test)
结局指标
主要结局
HbA1c
时间窗: 9 months
HbA1c over 9 months
次要结局
- Medication adherence as measured by Voils Scale(9 months)
- Quality of life as measured by EQ-5D-5L(9 months)
- Systolic blood pressure(9 months)
- Healthcare cost(9 months)
- Physical activity as measured by number of steps(9 months)
- Physical activity as measured by moderate to vigorous active minutes(9 months)
- Patient activation score as measured by patient activation measure(9 months)