Empowering Patients With Chronic Disease Using Profiling and Targeted Feedbacks Delivered Through Wearable Device (EMPOWER)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 8
- 主要终点
- Patient activation score as measured by patient activation measure
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. The objective is to design, develop and evaluate an adaptive interventional platform that is capable of delivering personalized behavioral nudges to promote and sustain healthy behavioral changes in senior patients with diabetes. The aim is to assess the clinical effectiveness of real-time personalized educational and behavioral interventions delivered through wearable (FitBit) and an in-integrative mobile application in improving patient activation scores measured using the patient activation measure (PAM). Secondary outcome measures include cost-effectiveness, quality of life, medication adherence, healthcare cost, utilization and lab results. Together with the experts from the SingHealth Regional Health System and National University of Singapore, the investigators will conduct a randomized controlled trial of 1,000 eligible patients. This proposal aims to achieve sustainable and cost-effective behavioral change in diabetes patients through patient-empowerment and targeted chronic disease care.
详细描述
Traditional healthcare facility-based consultation model of episodic contact in managing chronic disease patients have limited exposure to monitor and intervene patients' lifestyle factors. These factors have been found to be more effective in managing 3H than medication. The proposed adaptive platform will utilize wearable and mobile application technologies which has the ability to continuous track several physiological and lifestyle factors data (e.g. moderate to vigorous active minutes, resting heart rate, sleep hours and quality and dietary habits)
Similarly, due to the limited exposure that healthcare workers have with patients under the current consultation model, current health education and intervention tends to be "one size fits all", passive and "top down" knowledge-loading. Patients are expected to change their behavior or to remember health education knowledge after a consultation session. The proposed adaptive platform will be built using educational and behavioral cues obtained from multiple stakeholders (including patients) and multiple data sources with the aim to gather more comprehensive and targeted feedback that is relevant to patients' needs in their management of their 3H condition. As changes in lifestyle factors and habits takes time, the proposed platform can also provide timely and appropriate feedbacks and reminders to patients at a more constant interval as compared to current model of care when advice was only given during consultation follow-up
To be able to add healthy years to the life of the current and future seniors,behavioral interventions that are closely studied and carefully implemented without disruption to the daily activity of the seniors is needed to achieve a revolutionary improvement in current primary care management.
The investigators will conduct a qualitative study to have a deep and enriched understanding of the types of nudges that are suited for patients with chronic diseases. Through modelling approach using the electronic medical records, the proposed adaptive platform will profile patients into groups and pre-set the nudges that are suitable for them. This allows the investigators to identify patients that have a higher risk of complications of 3H and quickly match the desired nudges to change behavior.
The proposed adaptive platform also aims to empower patients by providing patients with automated bite-sized knowledge of their health conditions. Coupled with real-time personalized feedback to their health behaviors, patients will be equipped with the knowledge to take charge of their health using far lesser healthcare manpower and resources.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Patients will be screened and recruited for the RCT by research coordinators positioned in the SingHealth polyclinics. They will identify eligible patients according to the inclusion and exclusion criteria. Informed consent will be taken and they will be referred to the research coordinators who will randomly assign the patients to the intervention or control arm using a site-specific pre-generated randomization list. A research coordinator will keep custody of the 3 randomization lists (1 for each recruitment site), and assign treatment accordingly to the intervention listed and not be involved in the recruitment or assessment of patients.
入排标准
- 年龄范围
- 40 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 40 and above at time of recruitment
- •Have been diagnosed with diabetes at time of recruitment
- •Most recent HbA1c more than or equal to 7.0% mmol/l
- •Physically able to exercise
- •Literate in English
- •Agreeable to be monitored by FitBit and adaptive intervention platform
- •Able to conform to the FitBit monitoring schedule
排除标准
- •On insulin treatment
- •Require assistance with basic activities of daily living (BADL)
- •Have planned major operation or surgical procedure in the coming year at the time of recruitment
- •Cognitively impaired (scored more than or equal to 6 on the Abbreviated Mental Test)
结局指标
主要结局
Patient activation score as measured by patient activation measure
时间窗: 12 months
Difference in patient activation score between intervention and control at 12 months
次要结局
- Healthcare cost(12 months)
- Medication adherence as measured by Voils Scale(6 months, 12 months)
- Physical activity as measured by number of steps(12 months)
- Physical activity as measured by moderate to vigorous active minutes(12 months)
- Medication adherence as measured by Adherence to Refills and Medications Scale(6 months, 12 months)
- Quality of life as measured by SF36-v2(12 months)
- Quality of life as measured by EQ-5D-5L(6 months, 12 months)
- Diet as measured by calorie intake, carbohydrates and sugar intake(12 months)
- HbA1c(12 months)