Intervention for Diabetes With Education, Advancement and Support (IDEAS) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Change in Hemoglobin A1c
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Hemoglobin A1c
时间窗: 3 months, 6 months, 12 months
次要结局
- Change in Weight(3 months, 6 months, 12 months)
- Change in Cholesterol(3 months, 6 months, 12 months)
- Cost effectiveness and cost utility(1 year)
- Change in Quality of life - Measured with EQ5D(3 months, 6 months, 12 months)
- Change in Blood pressure(3 months, 6 months, 12 months)
研究者
Shaun Lee Wen Huey
Senior Lecturer
Monash University