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| ID | Type | Description | Link |
|---|---|---|---|
| European Commission | |||
| ICT support policy program | |||
| Contract Number 225023 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home telemonitoring | Experimental |
| |
| Usual care (control group) | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wireless monitors for disease specific clinical parameters. | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 0, 15, 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to permanent transfer to elderly homes | Measured at month 30 | |
| Total and average length of stay in hospital | Measured at month 30 | |
| Number of consultations with general practitioners |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reinhard W Prior, M.D. | Contact | +393341855067 | rprior@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Reinhard W Prior, M.D. | Health Information Management, Brussels, Belgium | Study Director |
| Helmut Prior, Prof. Dr. | Institute for Experimental Psychology, University of Düsseldorf, Germany (H.Prior is head of the data monitoring committee) |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Langeland Municipality | Langeland | 5900 | Denmark | |||
| East Tallin Central Hospital |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Measured at month 30 |
| Number of consultations with medical specialists | Measured at month 30 |
| Number of home visits by nurses | Measured at month 30 |
| Number of ambulance transports | Measured at month 30 |
| Number of accesses to emergency rooms | Measured at month 30 |
| Number of falls | Measured at month 30 |
| Number of femur fractures | Measured at month 30 |
| HbA1c change over time (only for participants with a diagnosis of diabetes) | Measured at month 30 |
| Survival | Measured at month 30 |
| Depression as measured by HADS | Measured at months 0, 15 and 30 |
| Number of hospitalisations | Measured at month 30 |
| Number of permanent transfers to elderly homes | Measured at month 30 |
| Tallinn |
| 10123 |
| Estonia |
| Pflegwerk Berlin, Mediplus | Berlin | 10439 | Germany |
| Azienda per i Servizi Sanitari ASS N.1 | Trieste | 34128 | Italy |
| Servicio Aragones de Salud | Barbastro | 22300 | Spain |
| GP Surgery | Heby | 74432 | Sweden |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |