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

This study is currently recruiting participants.
Verified March 2012 by University Hospital, Limoges
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01551121
First received: March 1, 2012
Last updated: November 26, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention
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
Study Design: Time Perspective: Prospective
Official Title: Assessment of an Automated Telesurveillance System on the Incidence of Serious Falls in Nursing Homes

Resource links provided by NLM:

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

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • The impact of the automated telesurveillance system on the risk ratio of falls [ Time Frame: one year ] [ Designated as safety issue: No ]
    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:
  • The impact of the system on global risk of falling [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The impact of the system on autonomy loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 216
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01551121     History of Changes
Other Study ID Numbers: I11 004
Study First Received: March 1, 2012
Last Updated: November 26, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on June 17, 2013