Assessment of an Automated Telesurveillance System on the Incidence of Serious Falls in Nursing Homes (TELEHPAD)
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| First Received Date ICMJE | March 1, 2012 | ||||||||
| Last Updated Date | November 26, 2012 | ||||||||
| Start Date ICMJE | March 2012 | ||||||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01551121 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Assessment of an Automated Telesurveillance System on the Incidence of Serious Falls in Nursing Homes | ||||||||
| Official Title ICMJE | 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Time Perspective: Prospective | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | old subject |
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| Condition ICMJE | The Elderly of 75 Years and Living in Nursing Homes | ||||||||
| Intervention ICMJE | 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. |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 216 | ||||||||
| Estimated Completion Date | March 2014 | ||||||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 75 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01551121 | ||||||||
| Other Study ID Numbers ICMJE | I11 004 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | University Hospital, Limoges | ||||||||
| Study Sponsor ICMJE | University Hospital, Limoges | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Limoges | ||||||||
| Verification Date | March 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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