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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 : Completed
First Posted : March 12, 2012
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Tracking Information
First Submitted Date March 1, 2012
First Posted Date March 12, 2012
Last Update Posted Date January 11, 2019
Actual Study Start Date March 2012
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 7, 2012)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01551121 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 7, 2012)
  • The impact of the system on global risk of falling [ Time Frame: 1 year ]
  • The impact of the system on autonomy loss [ Time Frame: 1 year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of an Automated Telesurveillance System on the Incidence of Serious Falls in Nursing Homes
Official Title Assessment of an Automated Telesurveillance System on the Incidence of Serious Falls in Nursing Homes
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population old subject
Condition The Elderly of 75 Years and Living in Nursing Homes
Intervention 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.
Study Groups/Cohorts
  • 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
    Intervention: Other: It will then allow them to intervene at the right time and the right place
  • non-equipped group
    Patient in the "non-equipped" group will have usual care
    Intervention: Other: It will then allow them to intervene at the right time and the right place
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 7, 2012)
216
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 75 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01551121
Other Study ID Numbers I11 004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Limoges
Study Sponsor University Hospital, Limoges
Collaborators Not Provided
Investigators
Study Director: Thierry DANTOINE, MD University Hospital, Limoges
Principal Investigator: Michel PAILLER, MD Gueret Hospital
PRS Account University Hospital, Limoges
Verification Date March 2016