Efektivitas "CARE Coaching Model" Sebagai Upaya Pemberdayaan Pasien Diabetes Untuk Meningkatkan Status Kesehatan Dan Perilaku Pengendalian Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from Baseline HbA1c at 3 months
研究概览
简要总结
In Indonesia and others countries, only 30.8% patients with type 2 diabetes mellitus (T2DM) achieved glycemic control with HbA1c <7%. Optimal pharmacological treatment alone does not guarantee an optimal outcome, therefore it should be combined with lifestyle management. Health coaching helps T2DM patients increase self awareness to improve and maintain behavior which play a role in self-management. This study aims to evaluate the impact of health coaching on glycemic control on T2DM patients.
详细描述
Subjects randomized into 2 groups: control and intervention group. All subject received education class in top of standard treatment. Intervention group received additional personal health coaching.
Education and health coaching was given for 12 sessions every 2 weeks with 12 different themes for each session. Health coaching were given by International certified health coach.
Laboratory examination and questionnaire collected at baseline, 3 and 6 months after intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T2DM patients
- •aged 30-60 years old
- •HbA1C > 7.5% within the past 3 months
- •able to write and read.
排除标准
- •Patients with cognitive disease (such as dementia)
- •having hearing problem or sight problem
- •unable to live independently on daily basis
- •having disease that may affect HbA1c result (eg: hemolytic anemia)
结局指标
主要结局
Change from Baseline HbA1c at 3 months
时间窗: 3 month after intervention
Glycemic Control
Change from Baseline HbA1c at 6 months
时间窗: 6 month after intervention
Glycemic Control
次要结局
- Change of Body mass index at 3 months(3 month after intervention)
- Change calorie intake at 3 months(3 month after intervention)
- Change from Baseline 2-hours post prandial plasma glucose at 6 months(6 months after intervention)
- Change of Body mass index at 6 months(6 months after intervention)
- Change from Baseline 2-hours post prandial plasma glucose at 3 months(3 months after intervention)
- Change from HDL-cholesterol at 3 months(3 months after intervention)
- International Physical Activity Questionnaire (IPAQ) questionnaire(baseline, 3 month and 6 months after intervention)
- Change from Total Cholesterol at 6 months(6 months after intervention)
- Change calorie intake at 6 months(6 months after intervention)
- Change from Total Cholesterol at 3 months(3 months after intervention)
- EQ-5D quality of life questionnaire(baseline, 3 month and 6 months after intervention)
- Change from HDL-cholesterol at 6 months(6 months after intervention)
- Change from Triglycerides at 6 months(6 months after intervention)
- Change from Baseline Fasting Plasma Glucose at 3 months(3 month after intervention)
- Change from Baseline Fasting Plasma Glucose at 6 months(6 month after intervention)
- Change from LDL-cholesterol at 6 months(6 months after intervention)
- Change from systolic and diastolic blood pressure at 6 months(6 months after intervention)
- Change from LDL-cholesterol at 3 months(3 months after intervention)
- Change from Triglycerides at 3 months(3 months after intervention)
研究者
Prof. Dr. dr. Pradana Soewondo, SpPD-KEMD
Professor, Endocrinologist
Indonesia University