An interventional study of Wireless monitors for disease specific clinical parameters. in Diabetes Mellitus, Chronic Heart Failure and Chronic Obstructive Pulmonary Disease, sponsored by Health Information Management, Belgium. Status unknown at 6 sites in 6 countries. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-05-08.
Sponsored by Health Information Management, Belgium · Not applicable, Interventional, and Health services research
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.
11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 300 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →This is the only study on the registry with Health Information Management, Belgium as lead sponsor.
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Inclusion Criteria:
Inclusion criteria:
Only in the case that the number of recruited participants is not sufficient, inclusion criteria can be extended to one or more of the following conditions:
Exclusion Criteria:
Device: Wireless monitors for disease specific clinical parameters.
Homes of participants will be equipped with wireless monitors for blood pressure, blood oxygen, blood glucose, peak expiratory flow, electrocardiogram, body weight. All vital parameters are monitored on a continuous, at least daily basis and obtained values are transmitted to a monitoring centre. Abnormal values are classified for their health risk and health alarms and/or intervention of health professionals is triggered.
Health related quality of life as assessed by the SF-36 questionnaire, at the beginning, at midterm and at the end of the trial period
Time frame: 0, 15, 30 months
Time to permanent transfer to elderly homes
Time frame: Measured at month 30
Total and average length of stay in hospital
Time frame: Measured at month 30
Number of consultations with general practitioners
Time frame: Measured at month 30
Number of consultations with medical specialists
Time frame: Measured at month 30
Number of home visits by nurses
Time frame: Measured at month 30
Number of ambulance transports
Time frame: Measured at month 30
Number of accesses to emergency rooms
Time frame: Measured at month 30
Number of falls
Time frame: Measured at month 30
Number of femur fractures
Time frame: Measured at month 30
HbA1c change over time (only for participants with a diagnosis of diabetes)
Time frame: Measured at month 30
Survival
Time frame: Measured at month 30
Depression as measured by HADS
Time frame: Measured at months 0, 15 and 30
Number of hospitalisations
Time frame: Measured at month 30
Number of permanent transfers to elderly homes
Time frame: Measured at month 30
This study is status unknown, as verified in May 2009. You cannot join it, but the record below documents what was studied.
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