- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01551121
Assessment of an Automated Telesurveillance System on the Incidence of Serious Falls in Nursing Homes (TELEHPAD)
January 10, 2019 updated by: University Hospital, Limoges
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
216
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Limoges, France, 87 042
- Limoges university hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
75 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
old subject
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The impact of the system on global risk of falling
Time Frame: 1 year
|
1 year
|
The impact of the system on autonomy loss
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michel PAILLER, MD, Gueret Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2012
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
March 1, 2012
First Submitted That Met QC Criteria
March 7, 2012
First Posted (Estimate)
March 12, 2012
Study Record Updates
Last Update Posted (Actual)
January 11, 2019
Last Update Submitted That Met QC Criteria
January 10, 2019
Last Verified
March 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- I11 004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on The Elderly of 75 Years and Living in Nursing Homes
-
University Hospital, LimogesCompletedthe Elderly of 75 Years and Older Living at HomeFrance
-
National Taipei University of Nursing and Health...RecruitingThe Effectiveness of Precision Nursing Intervention Program on Cognitive Function、Sleep Quality and Emotional State of Frail Femal Elderly in the CommunityTaiwan
-
University of NebraskaNational Institute of Nursing Research (NINR); National Institutes of Health...CompletedQuality of End-of-life Care in Nursing HomesUnited States
-
Taichung Veterans General HospitalUnknown
-
Chiayi Christian HospitalNational Cheng Kung UniversityUnknownQuality of Life | Cognitive Impairment | Aging | Depression in Old Age | Nursing HomesTaiwan
-
Semey State Medical UniversityMinistry of Science and Higher Education of the Republic of KazakhstanRecruitingImproving the Early Diagnosis of Osteoporosis in Adults and Children Living in the Abay Region of KazakhstanKazakhstan
-
Universitaire Ziekenhuizen KU LeuvenKU LeuvenCompletedCardiovascular Diseases | Delirium | Frail Elderly | Activities of Daily Living | Geriatric Assessment | Length of Stay | Health Services for the AgedBelgium
-
Institute of Hematology & Blood Diseases HospitalNot yet recruitingThe Effecacy and Safety of Humanized CD25 Antibody in aGVHD Prophylaxis Among Elderly Patients After HID-HSCT
-
University of FloridaNational Institute on Aging (NIA)Enrolling by invitationFrailty | Rehabilitation | Frail Elderly | Activities of Daily Living | Functional Status | Occupational Therapy | Physical Functional Performance | Treatment Outcome | Health Services for the Aged | Home Health CareUnited States
-
China Medical University HospitalUnknownCondition 1. Children With ALL Are Still Alive and the Age of 18 Years of Age. | Condition 2. Has Been Completed to Guide the Treatment Regimen Were in Remission. | Condition 3. Caregiver Can or Taiwanese Language Communicator.Taiwan
Clinical Trials on It will then allow them to intervene at the right time and the right place
-
Johnson & Johnson Consumer Inc. (J&JCI)CompletedSkin Regeneration After Dermatological Facial Procedure With Fractional CO2 LaserBrazil
-
Cambridge University Hospitals NHS Foundation TrustObstetric Anaesthetists' AssociationRecruitingAnesthesiaUnited Kingdom
-
Memorial Sloan Kettering Cancer CenterWeill Medical College of Cornell University; McMaster UniversityCompleted
-
Memorial Sloan Kettering Cancer CenterUniversity of Michigan; University of North Carolina, Chapel HillCompletedBreast CancerUnited States
-
Memorial Sloan Kettering Cancer CenterSamus TherapeuticsActive, not recruitingNon-Hodgkin's Lymphoma | Myeloma | Active Solid MalignancyUnited States
-
Memorial Sloan Kettering Cancer CenterCelgene CorporationCompletedLeukemia | Chronic Lymphocytic LeukemiaUnited States
-
Luxembourg Institute of HealthLuxembourg Centre for Systems Biomedicine; FNR (Luxembourg National Research... and other collaboratorsNot yet recruiting
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingBreast Cancer | Atrophic VaginitisUnited States
-
Nantes University HospitalCompletedPatients Receiving Animal-derived Bioprosthetic Heart ValvesFrance, Canada, Italy, Spain
-
Memorial Sloan Kettering Cancer CenterPfizer; Dana-Farber Cancer Institute; University of Pittsburgh; University of VirginiaCompletedNeurofibromatosis | Meningioma | CNS Cancer | Hemangioblastoma | Intracranial HemangiopericytomaUnited States