The Integration of Health Coaching and Diabetes Education in Type 2 Diabetes Mellitus Patients at Jakarta Primary Health Care: Role on Metabolic Control, Diabetes Complications, Inflammatory Marker, Behavior Changes, and Quality of Life
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change from baseline HbA1C at 3 months and 6 months
研究概览
简要总结
Type 2 Diabetes Mellitus is a chronic disease with increasing incidence globally. It needs a comprehensive and continuous management approach that includes five pillars: education, nutritional management, physical activity, pharmacological treatment, and monitoring. To achieve good glycemic control, prevention of complications, and good quality of life as diabetes management goals, patients' capability to properly navigate diabetes management is a key. One evidence-based model to empower patients' self-management abilities is diabetes education and health coaching. Diabetes management at primary health care needs special concern since they play an important role in initial and continuing care for diabetes patients in the community. Therefore, the implementation of diabetes education and health coaching in primary health care is expected to improve the self-management abilities of people with diabetes
详细描述
A randomized control trial, pre and post study involving 180 subjects randomized into 2 arms:
- Control : received education in group
- Intervention : received education group + personal health coaching Education group divided into 6 session, which for each session consist of 2 different topics and lasts for 60 minutes.
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.
Laboratory examination, anthropometric measurement, echocardiography, electrocardiography, Heart Rate Variability measurement, diabetic eye screening, 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes Mellitus
- •>= 18 years old
- •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
结局指标
主要结局
Change from baseline HbA1C at 3 months and 6 months
时间窗: Baseline, 3 and 6 months after intervention
HbA1C is indicator of glycemic control
次要结局
- Change from baseline body mass index(Baseline, 3 and 6 months after intervention)
- Change from baseline right ventricular systolic function(Baseline, 6 months after intervention)
- Change from baseline fasting plasma glucose at 3 and 6 months(Baseline, 3 and 6 months after intervention)
- Change from baseline serum lipid at 3 and 6 months(Baseline, 3 and 6 months after intervention)
- change from baseline left ventricular diastolic function(Baseline, 6 months after intervention)
- Baseline visual acuity(Baseline)
- Baseline lens haziness(Baseline)
- Change from baseline peripheral autonomic neuropathy(Baseline, 3 and 6 months after intervention)
- Baseline retina examination(Baseline)
- Change from baseline inflammatory marker at 3 and 6 months(Baseline, 3 and 6 months after intervention)
- Change from baseline left ventricular systolic function(Baseline, 6 months after intervention)
- Baseline intraocular pressure(Baseline)
- Change from baseline mean calorie intake(Baseline, 3 and 6 months after intervention)
- Change from baseline body fat(Baseline, 3 and 6 months after intervention)
- Change from baseline left atrial volume(Baseline, 6 months after intervention)
- Change from baseline electrocardiography pattern(Baseline and 6 months after intervention)
- Change from baseline peripheral arterial disease(Baseline, 3 and 6 months after intervention)
- Change from baseline waist circumference(Baseline, 3 and 6 months after intervention)
- Change from baseline left ventricular mass index(Baseline, 6 months after intervention)
- Change from baseline heart rate variability(Baseline and 6 months after intervention)
- Change from baseline peripheral sensory neuropathy(Baseline, 3 and 6 months after intervention)
- Change from baseline albuminuria(Baseline and 6 months after intervention)
- Change from baseline peripheral motor neuropathy(Baseline, 3 and 6 months after intervention)
- Change from baseline renal function(Baseline and 6 months after intervention)
- Change from baseline medication adherence(Baseline, 3 and 6 months)
- Change from baseline quality of life(Baseline, 3 and 6 months)
- Change from baseline global physical activity(Baseline, 3 and 6 months after intervention)
研究者
Em Yunir
DR. dr. Em Yunir, SpPD, KEMD
Indonesia University