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Clinical Trial NCT00893685 (Dreaming) for Diabetes Mellitus, Chronic Heart Failure, Chronic Obstructive Pulmonary Disease is unknown status. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Randomized Controlled Trial of Home Telemonitoring for Elderly People (Dreaming) 300 Randomized Senior-Focused
Clinical Trial NCT00893685 (Dreaming) is an interventional study for Diabetes Mellitus, Chronic Heart Failure, Chronic Obstructive Pulmonary Disease that is unknown status. It started on May 1, 2009 with plans to enroll 300 participants. Led by Health Information Management, Belgium, it is expected to complete by December 1, 2011. The latest data from ClinicalTrials.gov was last updated on May 8, 2009.
Brief Summary
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 t...Show More
Detailed Description
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 transmitte...Show More
Official Title
Elderly Friendly Alarm Handling and Monitoring (DREAMING)
Conditions
Diabetes MellitusChronic Heart FailureChronic Obstructive Pulmonary DiseaseOther Study IDs
- Dreaming
- European Commission
- European Commission
- ICT support policy program
- Contract Number 225023
NCT ID Number
Start Date (Actual)
2009-05
Last Update Posted
2009-05-08
Completion Date (Estimated)
2011-12
Enrollment (Estimated)
300
Study Type
Interventional
PHASE
N/A
Status
Unknown status
Keywords
Telemedicine
Primary Purpose
Health Services Research
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalHome telemonitoring | 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 trig...Show More |
No InterventionUsual care (control group) | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | 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 |
| Outcome Measure | 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 | 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 |
Eligibility Criteria
Eligible Ages
Older Adult
Minimum Age
65 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
Inclusion criteria:
- Diagnosis of chronic heart failure
- Diagnosis of diabetes mellitus
- Diagnosis of chronic obstructive pulmonary disease
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:
- History of myocardial infarction
- History of stroke (brain ischemia or hemorrhage)
- History of falls within the last two years
- Hospitalization during the last two years (for every reason)
- Not willing to participate (e.g non signing informed consent)
- Inability to use the DREAMING equipment
- Significant impairment of language comprehension or expression (aphasia)
- Diagnosis of dementia
- Completely dependent on others for the activities of daily living
- Living without access to ISDN or DSL service
Health Information Management, BelgiumStudy Central Contact
Contact: Reinhard W Prior, M.D., +393341855067, [email protected]
6 Study Locations in 6 Countries
GP Surgery, Heby, 74432, Sweden
Langeland Municipality, Langeland, 5900, Denmark
Pflegwerk Berlin, Mediplus, Berlin, 10439, Germany
East Tallin Central Hospital, Tallinn, 10123, Estonia
Azienda per i Servizi Sanitari ASS N.1, Trieste, 34128, Italy
Servicio Aragones de Salud, Barbastro, 22300, Spain