Intervention for Diabetes With Education, Advancement and Support (IDEAS)
Intervention for Diabetes With Education, Advancement and Support (IDEAS) Study
This study aims to evaluate a culturally appropriate, low cost and sustainable management plan for patients with type 2 diabetes mellitus (T2DM). Various randomized controlled trials confirmed that T2DM can be delayed with lifestyle intervention and programmes which promote improvements in diet, increased physical activity and weight loss. Translation of lifestyle intervention to real-life settings however remains a major challenge.
The investigators therefore propose a diabetes management trial for T2DM patients using telemedicine. This project's innovations include the use of information technology to deliver messages to the physicians while similarly involving family members of diabetics to manage the patient's condition collectively. This creates a sense of well-being, empowering the individual as well as the community to be responsible for their own health and well-being
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Selangor
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Klang、Selangor、马来西亚、42000
- Klinik Kesihatan Pandamaran
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Type 2 diabetes diagnosed by a physician at least six months prior to study enrollment
- HbA1c of > 7.5% but less than 11.0% within the most recent 3 months
- Access to internet and an e-mail address , or access to a smartphone with 3G services
- Not pregnant or history of heart diseases, serious illness, cancer diagnosis or any other conditions that can impede participation
Exclusion Criteria:
- Unable or unwilling to give informed consent or communicate with local study staff
- Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
- Hospitalization for depression in past six months
- Plans to relocate to an area or travel plans that do not permit full participation in the study
- Lack of support from primary health care provider or family members
- History of bariatric surgery, small bowel resection, or extensive bowel resection
- Currently pregnant or nursing
- Cancer: requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer)
- Cardiovascular disease (heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within last three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months)
- Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:Usual care
Diabetes education and support in person
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A 15-30 minute diabetes self-management session.
Continued care, as usual, from their primary care provider throughout duration of active 12 month intervention period.
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实验性的:Telemedicine
Diabetes education and support via telemedicine
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A diabetes self-management and education program delivered via telemedicine
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Change in Hemoglobin A1c
大体时间:3 months, 6 months, 12 months
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3 months, 6 months, 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in Quality of life - Measured with EQ5D
大体时间:3 months, 6 months, 12 months
|
3 months, 6 months, 12 months
|
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Change in Blood pressure
大体时间:3 months, 6 months, 12 months
|
3 months, 6 months, 12 months
|
|
Change in Weight
大体时间:3 months, 6 months, 12 months
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3 months, 6 months, 12 months
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Cost effectiveness and cost utility
大体时间:1 year
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The objectives are to compare the results of the study to that of usual care in patients with type 2 diabetes in terms of cost, cost-effectiveness and cost utility of these two strategies.
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1 year
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Change in Cholesterol
大体时间:3 months, 6 months, 12 months
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3 months, 6 months, 12 months
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合作者和调查者
合作者
出版物和有用的链接
一般刊物
- Lee JY, Chan CKY, Chua SS, Paraidathathu T, Lee KK, Tan CSS, Nasir N, Lee SWH. Using telemedicine to support care for people with type 2 diabetes mellitus: a qualitative analysis of patients' perspectives. BMJ Open. 2019 Oct 22;9(10):e026575. doi: 10.1136/bmjopen-2018-026575.
- Lee JY, Chan CKY, Chua SS, Ng CJ, Paraidathathu T, Lee KKC, Lee SWH. Telemonitoring and Team-Based Management of Glycemic Control on People with Type 2 Diabetes: a Cluster-Randomized Controlled Trial. J Gen Intern Med. 2020 Jan;35(1):87-94. doi: 10.1007/s11606-019-05316-9. Epub 2019 Sep 11.
- Lee JY, Chan CK, Chua SS, Ng CJ, Paraidathathu T, Lee KK, Lee SW. Intervention for Diabetes with Education, Advancement and Support (IDEAS) study: protocol for a cluster randomised controlled trial. BMC Health Serv Res. 2016 Sep 29;16(1):524. doi: 10.1186/s12913-016-1782-y.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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