Large Scale Demonstrator, Webportal Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Health Related Quality of Life
研究概览
简要总结
Rationale: Accounting for the growth, aging and detrimental life style changes in the Dutch population, the investigators expect further growth of number of known diabetes patients. The economic burden with this increase will be enormous, the healthcare system is under increasing pressure to provide better but more time efficient service to more people with limited human resources. the investigators hypothesize that, by increasing the patients self-management by offering remote care services, this reduction of the individual caseload can be achieved.
Objective: Primary objective is to test the hypothesis that the consistent use of a web portal and its educational content and the possibility to review personal diabetes related data for type 2 diabetes patients (T2DM) in the primary care setting, will result in an improvement quality of life.
Study design and methods: In this Prospective observational cohort study the investigators examine the effect of the voluntarily use of a web portal and its educational content. The primary end point is health related quality of life. We predefined a clinically relevant difference of 0.074 in the EQ-5D index score. Secondary endpoints are diabetes-related distress and well being and a selection of clinical measurements, number of contacts with health care provider and the amount of prescribed medication. The participants are being followed for 1-year and the data will be collected at baseline, after 6 months and 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •A diagnosis of type 2 diabetes mellitus, as registered in the primary care system under the diagnosis T90.2, and where the GP is defined as the main care giver
- •Aged 18 years or older
排除标准
- •Cohort study:
- •Intervention study:
- •Mental retardation or psychiatric treatment for schizophrenia, organic mental disorder or bipolar disorder currently or in the past
- •Insufficient knowledge of the Dutch language to understand the requirements of the study and/or the questions posed in the questionnaires
- •Life expectancy < 1 year due to malignancies or other terminal illnesses
- •Cognitive impairment, including dementia, that interferes with trial participation
- •Any condition that the Investigator and/or Coordinating Investigator feels would interfere with trial participation or evaluation of results
结局指标
主要结局
Health Related Quality of Life
时间窗: 12 months
EQ-5D questionnaire, representing Health Related Quality of Life dimension
次要结局
- Diabetes-related distress(12 months)
- Evaluation of general practice(12 months)
- Assessing self-efficacy(12 months)
- Well-being Index: WHO-5 questionnaire(12 months)
- Clinical parameters(12 months)
研究者
Henk Bilo, MD
professor
Medical Research Foundation, The Netherlands