Diabetes Mellitus Clinical Trial
Official title:
Elderly Friendly Alarm Handling and Monitoring (DREAMING)
The DREAMING clinical trial is part of the DREAMING project, which has the objective to demonstrate that the DREAMING platform consisting of integrated health monitoring, alarm handling and videoconferencing services produces clinical benefits to its users and economic benefits to the health authorities. The study evaluates the long-term (30 months) effect of continuous use of the DREAMING subsystems and is testing the hypothesis that such use is superior to usual care alone in reducing the deterioration of health related quality of life that is associated to age and chronic disease. It also tests the hypothesis that the DREAMING environment is superior to usual care in delaying the transfer to nursing or elderly homes and in reducing the incidence and duration of hospitalisation episodes. The trial will also evaluate the cost-effectiveness of the DREAMING platform. Outcomes are assessed in six different health care systems (Denmark, Estonia, Germany, Italy, Spain and Sweden) and will represent a basis for the adoption of DREAMING services by the respective health authorities.
Homes of participants are equipped with environmental sensors, motion detection, and with wireless sensors for blood pressure, blood glucose, body weight, blood oxygen saturation, peak expiratory flow and electrocardiogram. Disease related parameters are monitored at least daily and the measured values are transmitted to a central monitoring unit. In case of abnormal values, health alarms are generated and transmitted to the local health authorities to trigger eventual intervention by the physicians and nurses who normally follow the participants. Participants and health professionals can stay in contact via an easy to use, home television based videoconferencing system. Participants are also equipped with a a personal alarm and GPS-enhanced localisation system. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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