E-support for Healthcare Processes - DIABETES
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change From Baseline in HbA1C at 1 Year.
研究概览
简要总结
The purpose of the study is to clinically evaluate a new approach to treatment of patients with diabetes mellitus type II by using specially developed mobile-internet software solution.
The effect of information and communication technologies (ICT) to improve the integrated care of people with diabetes will be identified, developed, introduced and clinically evaluated.
The investigators expect that usage of an e-Health application in health care of patients with diabetes mellitus type II could improve the following healthcare outcomes: results of the laboratory tests (with emphasis on HbA1C value), regular medication usage, blood pressure values, Body mass index (BMI) values, diet, regular exercise and quality of life.
详细描述
Diabetes mellitus (DM) is defined as a "group of common metabolic disorders that share the phenotype of hyperglycemia". It is generally agreed that in Caucasian populations the prevalence rate is between 2% and 6%. Prevalence rate of DM in SLovenia is about 5%. Type 2 DM accounts for 90% to 95% of all diabetes cases.
Results of many clinical studies demonstrated the great potential of information and communication technology (ICT) applications to improve health care of patients with chronic diseases including diabetes mellitus.
In this study an ICT mobile environment to improve the process of an integrated care of people with Diabetes mellitus will be identified, developed, introduced and clinically evaluated. The study will include 140 patients diagnosed with diabetes mellitus type II who are managed in primary care. The study will use and evaluation questionnaire that will cover issues regarding the patient quality of life.
Subjects with a blood pressure meter and a scale, will be able to enter the value of the systolic and diastolic blood pressure and the body weight.
Subjects will be motivated to regularly enter data about their blood pressure, body weight, dietary misconducts and to complete available questioners. In addition to this, users can enter values about their physical activity (type, duration, intensity).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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, treated with non-pharmacological interventions or/and tablets (Non-Insulin-Dependent Diabetes Mellitus)
- •Internet connection and personal computer /lap-top computer
- •Mobile phone
- •Sufficient level of Internet and e-mail usage - checked by short questionnaire
- •Age >18 or <75 years
排除标准
- •significant co-morbidity
- •Type 1 diabetes
- •Insulin-dependent type 2 diabetes
研究组 & 干预措施
Diabetes with ICT support (E-diabetes)
The group of randomly selected patients with DM type II, who will get the software application and web- based support Intervention: Computerised support to the Diabetes type II patients
干预措施: Computerised support to the Diabetes type II patients (Procedure)
Diabetes without support
The group of randomly selected patients with DM type II, without software application and web-based support.
结局指标
主要结局
Change From Baseline in HbA1C at 1 Year.
时间窗: 1 year
次要结局
- Body Mass Index at 1 Year(one year)
- Patients' Functional Health Status Via WONCA-COOP Questionnaire.(one year)
- Change of Blood Lipid Level ( Low Density Cholesterol)(baseline and six months)
- Quality of Patients' Life Via WONCA-COOP Questionnaire.(baseline and one year)
- Change of Patients' Functional Health Status Via WONCA-COOP Questionnaire.(baseline and one year)
- Change of the Following Parameter : HbA1C(baseline and six months)
- Change of Blood Lipid Level ( Low Density Cholesterol)(baseline and one year)