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Assessment of an Automated Telesurveillance System on the Incidence of Serious Falls in Nursing Homes (TELEHPAD)

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ClinicalTrials.gov Identifier: NCT01551121
Recruitment Status : Recruiting
First Posted : March 12, 2012
Last Update Posted : August 22, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Brief Summary:
3 Nursing homes in the Limousin region will be equipped with the automated telesurveillance system. Patient will be selected by general practitioner 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 three times during the study, at inclusion, 6 months and 12 months. Each assessment is composed of a standard geriatric assessment, a fall questionnaire, an autonomy scale (SMAF scale) and a quality of life questionnaire (EQ5D). Every falls will be considered as adverse events and will therefore be listed along the study and characterized in types and number.

Condition or disease Intervention/treatment
The Elderly of 75 Years and Living in Nursing Homes Other: It will then allow them to intervene at the right time and the right place

Study Type : Observational
Estimated Enrollment : 216 participants
Time Perspective: Prospective
Official Title: Assessment of an Automated Telesurveillance System on the Incidence of Serious Falls in Nursing Homes
Study Start Date : March 2012
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls Nursing Homes
U.S. FDA Resources

Group/Cohort Intervention/treatment
intervention group
Patient in the "intervention group" will have camera installed in their room. These cameras can either work in visible or infrared range. They are physically linked to a server that will store and analyze images in real-time. The server works 24h/24 and 7d/7 and will send an alert to the care personnel via their computers and personal pagers if it detects an anomaly. Anomaly could be falls, high risk behavior (patient standing up on its bed), abnormal length of stay in the bathroom, prolonged inertia. It will then allow them to intervene at the right time and the right place. Geriatrician can also review images in order to determine the cause of the incident and then act on each patient prevention and care strategy
Other: It will then allow them to intervene at the right time and the right place
The server works 24h/24 and 7d/7 and will send an alert to the care personnel via their computers and personal pagers if it detects an anomaly. Anomaly could be falls, high risk behavior (patient standing up on its bed), abnormal length of stay in the bathroom, prolonged inertia. It will then allow them to intervene at the right time and the right place. Geriatrician can also review images in order to determine the cause of the incident and then act on each patient prevention and care strategy.
non-equipped group
Patient in the "non-equipped" group will have usual care
Other: It will then allow them to intervene at the right time and the right place
The server works 24h/24 and 7d/7 and will send an alert to the care personnel via their computers and personal pagers if it detects an anomaly. Anomaly could be falls, high risk behavior (patient standing up on its bed), abnormal length of stay in the bathroom, prolonged inertia. It will then allow them to intervene at the right time and the right place. Geriatrician can also review images in order to determine the cause of the incident and then act on each patient prevention and care strategy.



Primary Outcome Measures :
  1. The impact of the automated telesurveillance system on the risk ratio of falls [ Time Frame: one year ]
    The impact of the automated telesurveillance system on the risk ratio of falls with serious outcomes between the two groups at one year


Secondary Outcome Measures :
  1. The impact of the system on global risk of falling [ Time Frame: 1 year ]
  2. The impact of the system on autonomy loss [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
old subject
Criteria

Inclusion Criteria:

  • Patient aged more than 75 years old
  • Patient living in Limoges or Gueret nursing home
  • Patient informed consent and/or proxy consent
  • Patient able to understand the study, respect its imperatives and able to do evaluations
  • Patient able to stand up from the bed
  • Patient covered by the French health insurance

Exclusion Criteria:

  • Patient with a short term prognosis pathology
  • In multiple bed rooms, if at least one patient does not agree with the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01551121


Contacts
Contact: Thierry DANTOINE, MD (+33)(0)555056957 thierry.dantoine@chu-limoges.fr

Locations
France
Limoges University hospital Recruiting
Limoges, France, 87 042
Contact: Thierry DANTOINE, MD         
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Study Director: Thierry DANTOINE, MD University Hospital, Limoges
Principal Investigator: Michel PAILLER, MD Gueret Hospital

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01551121     History of Changes
Other Study ID Numbers: I11 004
First Posted: March 12, 2012    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: June 2016