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. (see Contacts and Locations)
Verified March 2012 by University Hospital, Limoges
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01561872
First received: March 21, 2012
Last updated: October 31, 2013
Last verified: March 2012
  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 2014
Estimated Primary Completion Date: June 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: October 31, 2013
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 August 21, 2014