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| Sponsored by: |
Health Information Management, Belgium |
|---|---|
| Information provided by: | Health Information Management, Belgium |
| ClinicalTrials.gov Identifier: | NCT00893685 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes Mellitus Chronic Heart Failure Chronic Obstructive Pulmonary Disease |
Device: Wireless monitors for disease specific clinical parameters. |
| Study Type: | Interventional |
| Study Design: | Health Services Research, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Elderly Friendly Alarm Handling and Monitoring (DREAMING) |
| Estimated Enrollment: | 300 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Home telemonitoring: Experimental |
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. |
| Usual care (control group): No Intervention |
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.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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:
Contacts and Locations| Contact: Reinhard W Prior, M.D. | +393341855067 | rprior@gmail.com |
| Denmark | |
| Langeland Municipality | |
| Langeland, Denmark, 5900 | |
| Estonia | |
| East Tallin Central Hospital | |
| Tallin, Estonia, 10123 | |
| Germany | |
| Pflegwerk Berlin, Mediplus | |
| Berlin, Germany, 10439 | |
| Italy | |
| Azienda per i Servizi Sanitari ASS N.1 | |
| Trieste, Italy, 34128 | |
| Spain | |
| Servicio Aragones de Salud | |
| Barbastro, Spain, 22300 | |
| Sweden | |
| GP Surgery | |
| Heby, Sweden, 74432 | |
| Study Director: | Reinhard W Prior, M.D. | Health Information Management, Brussels, Belgium |
More Information
| Responsible Party: | Health Information Management Sa, Belgium ( Marco D'Angelantonio ) |
| Study ID Numbers: | European Commission, European Commission, ICT support policy program, Contract Number 225023 |
| Study First Received: | April 22, 2009 |
| Last Updated: | May 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00893685 History of Changes |
| Health Authority: | Denmark: The Regional Committee on Biomedical Research Ethics; Estonia: The State Agency of Medicine; Germany: Ethics Commission; Italy: Ethics Committee; Spain: Ethics Committee; Sweden: Regional Ethical Review Board |
|
Telemedicine |
|
Heart Failure Lung Diseases, Obstructive Heart Diseases Metabolic Diseases Respiratory Tract Diseases Lung Diseases |
Diabetes Mellitus Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Pulmonary Disease, Chronic Obstructive |
|
Lung Diseases, Obstructive Heart Failure Heart Diseases Metabolic Diseases Respiratory Tract Diseases Lung Diseases |
Diabetes Mellitus Endocrine System Diseases Cardiovascular Diseases Glucose Metabolism Disorders Pulmonary Disease, Chronic Obstructive |
