RENEWING HEALTH - Large Scale Pilot in Veneto Region: Life-long Monitoring of Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 598
- 试验地点
- 1
- 主要终点
- Health related quality of life of the patients measured by the SF-36 version 2 questionnaire
研究概览
简要总结
To evaluate whether patients with type 2 diabetes mellitus can be followed by simplified, centralized and large scale tele-monitoring of blood glucose levels, and whether this intervention produces health and economic benefits when introduced without major changes to the existing organization of a large treatment care center.
详细描述
The study is designed to evaluate the impact of telemonitoring on the management of Diabetes Mellitus compared with outpatient usual care. From a clinical point of view, the measurements of HbA1c will be taken to assess glycaemic control and the trial will allow to investigate how telemonitoring contributes to improve Diabetes mellitus patients health-related quality of life and reduct the access to hospital facilities (re-hospitalizations, bed-days, specialistic and ER visits) and the anxiety about health conditions. A cost-effectiveness and cost-utility analysis will be carried out in order to determine if and how telemonitoring helps to limit the healthcare expenditure. The evaluation will deal also with organizational changes and task shift due to telemonitoring introduction and patients and professionals perception towards the service.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 Diabetes
- •HbA1c > 53 mmol/mol (7.0 % according to NGSP)
- •Capability to use the devices provided
- •Being cognitively able to participate
- •Capability of filling in questionnaires in german or greek or italian language
- •Absence of severe comorbidity prevalent on diabetes with life expectancy < 12 months
排除标准
- •Pregnancy
研究组 & 干预措施
Control group
Usual care: treatment as usual
Self-monitoring for patients with Dibetes mellitus type 2
Self-monitoring for patients with Dibetes mellitus type 2
干预措施: Self-monitoring for patients with Dibetes mellitus (Other)
结局指标
主要结局
Health related quality of life of the patients measured by the SF-36 version 2 questionnaire
时间窗: At the entry point of intervention and at the end (12 months)
Glycated hemoglobin (HbA1c) levels
时间窗: At the entry point of intervention and at the end (12 months)
次要结局
- Bed days of care(12 months)
- Bed days of care due to diabetes.(12 months)
- Number of visits with specialists(12 months)
- Number of access to ER(12 months)
- Mental status measured through Hospital Anxiety and Depression Scale (HADS).(At the entry point of intervention and at the end (12 months))
- Number of visits with specialists in diabetic center(12 months)
- Number of hospitalisations.(12 months)
- Number of hospitalisations due to diabetes.(12 months)