Integrasi Edukasi Berbasis Aplikasi Dan "CARE Coaching Model" Pada Pengelolaan Pasien Diabetes Mellitus Tipe 2 Yang Menggunakan Insulin
试验速览
- 阶段
- 不适用
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Change from Baseline Hb1A1c at 3 months
研究概览
简要总结
Diabetes mellitus is increasing in incidence worldwide. The goal of management of diabetes is to achieve blood sugar control by minimizing side effects and preventing short and long term complications. Self-management becomes important in the management of diabetes mellitus. The use of mobile phone applications provides opportunities for the management of diabetics. In addition, health coaching is one of method used for empowering patients with chronic diseases, such as diabetes. This study aims to evaluate the impact of Mobile Application-Based Diabetes Education and health coaching in management of type 2 diabetes mellitus.
详细描述
A randomized control trial, pre and post study involving 105 subjects randomized into 3 arms:
- Control : received conventional education group
- Intervention 1 : received conventional education group + mobile application-based diabetes education
- Intervention 2 : received mobile application-based diabetes education + health coaching
Conventional education group divided into 6 session, which for each session consist of 2 different topics and lasts for 60 minutes.
Mobile application-based diabetes education is using DM Educorner (Diabetes Mellitus Education Corner) availablle in Google PlayStore. Education contents was delivered in articles, video and infographics.
Health coaching was given by a coach, a healthcare professional who undergo training to become a coach. Health coaching delivered as face to face between subjects and coach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Open label
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes Mellitus
- •multiple daily insulin injection (basal and rapid, or mixed)
- •30 - 65 years old
- •HbA1c > 8%
- •Using smartphone in daily lives.
- •Willing to follow the research by signing an informed consent
排除标准
- •Patients with cognitive disease (such as dementia)
- •Patients with hearing or sight problem
- •Unable to live independently on daily basis
- •Patients who have disease that may affect Hba1c such as hemolytic anemia, thalassemia
结局指标
主要结局
Change from Baseline Hb1A1c at 3 months
时间窗: 3 months
Glycemic control
次要结局
- Change from Baseline Total cholesterol at 3 months(3 months after intervention)
- Self-Monitoring Blood Glucose(through study completion, an average of 3 months)
- Change from Baseline High-density lipoprotein cholesterol (HDL-c) at 3 months(3 months after intervention)
- Change from Baseline Low-density lipoprotein cholesterol (LDL-c) at 3 months(3 months after intervention)
- Change from Baseline Triglycerides at 3 months(3 months after intervention)
- Change from Baseline Fasting plasma glucose at 3 months(3 months after intervention)
- Change from Baseline 2 hours-post prandial plasma glucose at 3 months(3 months after intervention)
- Mean of intake calories from food Record(at baseline, 3 months after intervention)
- Global Physical Activities Questionnaire(at baseline, 3 and 6 months after intervention)
研究者
Prof. Dr. dr. Pradana Soewondo, SpPD-KEMD
Professor, Endocrinologist
Indonesia University