The Effectiveness of "CARE Coaching Model" as an Effort to Empower Type 2 Diabetes Mellitus Patients
2022年11月1日 更新者：Prof. Dr. dr. Pradana Soewondo, SpPD-KEMD、Indonesia University
Efektivitas "CARE Coaching Model" Sebagai Upaya Pemberdayaan Pasien Diabetes Untuk Meningkatkan Status Kesehatan Dan Perilaku Pengendalian Diabetes
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
DKI Jakarta
-
Jakarta Pusat、DKI Jakarta、印度尼西亚、10430
- Faculty of Medicine, Universitas Indonesia
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
30年 至 60年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- T2DM patients
- aged 30-60 years old
- HbA1C > 7.5% within the past 3 months
- able to write and read.
Exclusion Criteria:
- 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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：Control
Conventional Education Class
|
|
|
实验性的：Coaching
Health Coaching
|
Health Coaching as face to face with a coach
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline HbA1c at 3 months
大体时间：3 month after intervention
|
Glycemic Control
|
3 month after intervention
|
|
Change from Baseline HbA1c at 6 months
大体时间：6 month after intervention
|
Glycemic Control
|
6 month after intervention
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline Fasting Plasma Glucose at 3 months
大体时间：3 month after intervention
|
Glycemic Control
|
3 month after intervention
|
|
Change from Baseline 2-hours post prandial plasma glucose at 3 months
大体时间：3 months after intervention
|
Glycemic control
|
3 months after intervention
|
|
Change from HDL-cholesterol at 3 months
大体时间：3 months after intervention
|
Diabetes mellitus control
|
3 months after intervention
|
|
Change from LDL-cholesterol at 3 months
大体时间：3 months after intervention
|
Diabetes mellitus control
|
3 months after intervention
|
|
Change from Triglycerides at 3 months
大体时间：3 months after intervention
|
diabetes mellitus control
|
3 months after intervention
|
|
Change from Total Cholesterol at 3 months
大体时间：3 months after intervention
|
Diabetes mellitus control
|
3 months after intervention
|
|
Change of Body mass index at 3 months
大体时间：3 month after intervention
|
Diabetes mellitus control
|
3 month after intervention
|
|
Change calorie intake at 3 months
大体时间：3 month after intervention
|
life style parameter
|
3 month after intervention
|
|
International Physical Activity Questionnaire (IPAQ) questionnaire
大体时间：baseline, 3 month and 6 months after intervention
|
consist of several question about activities in the whole week.
Scoring divided into 3 categories : low, moderate, high.
This questionnaire is to describe activities no to divided whether high score means good or bad
|
baseline, 3 month and 6 months after intervention
|
|
EQ-5D quality of life questionnaire
大体时间：baseline, 3 month and 6 months after intervention
|
This questionnaire consist of several question with 5 main outcome mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Subjects will answer the question with fully, half or none.
|
baseline, 3 month and 6 months after intervention
|
|
Change from Baseline Fasting Plasma Glucose at 6 months
大体时间：6 month after intervention
|
Glycemic Control
|
6 month after intervention
|
|
Change from Baseline 2-hours post prandial plasma glucose at 6 months
大体时间：6 months after intervention
|
Glycemic Control
|
6 months after intervention
|
|
Change from HDL-cholesterol at 6 months
大体时间：6 months after intervention
|
diabetes mellitus Control
|
6 months after intervention
|
|
Change from LDL-cholesterol at 6 months
大体时间：6 months after intervention
|
diabetes mellitus Control
|
6 months after intervention
|
|
Change from Triglycerides at 6 months
大体时间：6 months after intervention
|
diabetes mellitus Control
|
6 months after intervention
|
|
Change from Total Cholesterol at 6 months
大体时间：6 months after intervention
|
diabetes mellitus Control
|
6 months after intervention
|
|
Change from systolic and diastolic blood pressure at 6 months
大体时间：6 months after intervention
|
diabetes mellitus Control
|
6 months after intervention
|
|
Change calorie intake at 6 months
大体时间：6 months after intervention
|
life style parameter
|
6 months after intervention
|
|
Change of Body mass index at 6 months
大体时间：6 months after intervention
|
diabetes mellitus control
|
6 months after intervention
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Pradana Soewondo, Prof、Fakultas Kedokteran Universitas Indonesia
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年2月1日
初级完成 (实际的)
2018年8月31日
研究完成 (实际的)
2020年3月31日
研究注册日期
首次提交
2020年2月10日
首先提交符合 QC 标准的
2020年2月27日
首次发布 (实际的)
2020年2月28日
研究记录更新
最后更新发布 (实际的)
2022年11月2日
上次提交的符合 QC 标准的更新
2022年11月1日
最后验证
2022年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.