RENEWING HEALTH Large-scale Real-life Study in Finland
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 595
- 试验地点
- 2
- 主要终点
- Health related quality of life
研究概览
简要总结
The purpose of this trial is to determine if by structured telephone based health coaching programme supported by remote monitoring system among type 2 diabetes, coronary artery disease and heart failure patients the investigators are able to improve their quality of life as measured by the SF-36 questionnaire and reduce a value of HbA1c under 6,5 % among those type 2 diabetes patients who had elevated value of HbA1c when recruited.
详细描述
RENEWING HEALTH is a project covering 9 different European States. It aims at evaluation of innovative telemedicine services using a patient-centred approach and a common rigorous assessment methodology. In 9 European regions in the implementation of health-related information and communication technologies service solutions are already operational at local level for the remote monitoring and the treatment of chronic patients suffering from diabetes,chronic obstructive pulmonary disease or cardiovascular diseases. The services are designed to give patients a central role in the management of their own diseases, fine-tuning the choice and dosage of medications, promoting compliance to treatment, and helping health care professionals to detect early signs of worsening in the monitored pathologies. Every area will designed its own real-life trial with certain common elements.
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
- •Age > 18 years
- •Capability of filling in questionnaires in Finnish language.
- •Be able to use Remote Patient Monitoring System
- •Be able to use the devices provided
- •Has adequate cognitive capacities to participate
- •In their medical records, one or both of the following diagnoses:
- •a) Type 2 Diabetes, for enrolment
- •diagnosed over 3 months prior to the enrolment and
- •HbA1c > 6,5 % b) Heart Disease, for enrolment
- •Ischemic heart disease or
- •Heart Failure or
- •Atrial fibrillation or
- •Other arrhythmia
- •Be able to walk
排除标准
- •Not willing to participate (e.g., not willing to sign the consent)
结局指标
主要结局
Health related quality of life
时间窗: 12 months
Health related quality of life is assessed by the SF-36 questionnaire.
HbA1c change over time (participants with T2DM only)
时间窗: 12 months
次要结局
- Weight reduction(12 months)
- Activity increase(12 months)
- Alcohol use reduction(12 months)
- Medication compliance(12 months)
- Blood pressure reduction(12 months)
- Smoke cessation(12 months)
- Cost for the organization(12 months)
- Satisfaction and usability of the technology and equipments.(12 months)
研究者
Tuula Karhula
Substitute Director of Elderly Services
South Karelia, Social and Health Care District