Assessment of an Automated Telesurveillance System on Serious Falls Prevention in an Elderly Suffering From Dementia Specialized Care Unit: the URCC (GET-BETTER)
This study is currently recruiting participants.
Verified March 2012 by University Hospital, Limoges
Sponsor:
University Hospital, Limoges
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01561872
First received: March 21, 2012
Last updated: December 4, 2012
Last verified: March 2012
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Purpose
2 URCC in the Limousin region will be equipped with the automated telesurveillance system. Patient will be selected by ward's geriatrician and randomized into two groups after informed consent. One group will have cameras installed and the other will not and will act as a comparison group. Patient will be assessed twice during the study, at admission in (inclusion visit) and at outcome from the URCC (end of study visit). Each assessment implies a standard geriatric assessment, a fall questionnaire, a Neuropsychiatric inventory for behavioral disturbances and a quality of life questionnaire (EQ5D). Every fall will be considered as adverse events and will therefore be listed along the study and characterized in types and number.
| Condition |
|---|
|
Mentally Ill Old Subjects |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Assessment of an Automated Telesurveillance System on Serious Falls Prevention in an Elderly Suffering From Dementia Specialized Care Unit: the URCC. GET-BETTER Study (Geriatric Environmental Telecare - Behavioral Engineering Technology To Enhance Rehabilitation) |
Resource links provided by NLM:
Further study details as provided by University Hospital, Limoges:
Primary Outcome Measures:
- The impact of the automated telesurveillance system [ Time Frame: 6 months ] [ Designated as safety issue: No ]The impact of the automated telesurveillance system on the incidence rate of falls with serious outcomes between the two groups during their hospitalization in URCC.
Secondary Outcome Measures:
- The impact of the system on the global rate of falls [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 350 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
intervention group
Rooms of the patient of the "intervention group" will be equipped of cameras
|
|
reference group
Patient in the "non-equipped" group will have usual care
|
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
demented old subjects
Criteria
Inclusion Criteria:
- Patient aged more than 65 years old
- Patient admitted in Limoges or Brive's URCC
- Patient informed consent and/or proxy consent
- Patient covered by the French health insurance
Exclusion Criteria:
- Patient without national health insurance coverage
- Patient with a short term prognosis pathology
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01561872
Contacts
| Contact: Thierry DANTOINE, MD | +33 (0)5 55 05 69 57 | thierry.dantoine@chu-limoges.fr |
Locations
| France | |
| Limoges University Hospital | Recruiting |
| Limoges, France, 87042 | |
| Contact: Thierry DANTOINE, Professor | |
Sponsors and Collaborators
University Hospital, Limoges
Investigators
| Study Director: | Thierry DANTOINE, MD | University Hospital, Limoges |
More Information
No publications provided
| Responsible Party: | University Hospital, Limoges |
| ClinicalTrials.gov Identifier: | NCT01561872 History of Changes |
| Other Study ID Numbers: | I11 005 |
| Study First Received: | March 21, 2012 |
| Last Updated: | December 4, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Dementia Stress, Psychological Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013