The Elderly of 75 Years and Living in Nursing HomesTELEHPADNCT01551121
Assessment of an Automated Telesurveillance System on the Incidence of Serious Falls in Nursing Homes
An observational study of The Elderly of 75 Years and Living in Nursing Homes, run by University Hospital, Limoges at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- The Elderly of 75 Years and Living in Nursing Homes
- What is being tested?
- It will then allow them to intervene at the right time and the right place
- How many people
- 216 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: old subject
Who may be able to join
- 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
Who cannot join
- Patient with a short term prognosis pathology
- In multiple bed rooms, if at least one patient does not agree with the trial
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- It will then allow them to intervene at the right time and the right place
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
It will then allow them to intervene at the right time and the right placeOther
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: It will then allow them to intervene at the right time and the right place |
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of the automated telesurveillance system on the risk ratio of falls
The impact of the automated telesurveillance system on the risk ratio of falls with serious outcomes between the two groups at one year
Measured: one year
Secondary outcomes (2)
The impact of the system on global risk of falling
Measured: 1 year
The impact of the system on autonomy loss
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Elderly of 75 Years and Living in Nursing HomesStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry DANTOINE, MD, Study director, University Hospital, LimogesMichel PAILLER, MD, Principal investigator, Gueret Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551121
- Sponsor's protocol ID
- I11 004
- Acronym
- TELEHPAD
- Status last verified
- Mar 2016
- First submitted
- 1 Mar 2012
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of an Automated Telesurveillance System on the Incidence of Serious Falls in Nursing Homes
- ClinicalTrials.gov ID
- NCT01551121
- Acronym / sponsor ID
- TELEHPAD / I11 004
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 12 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | – | Other: It will then allow them to intervene at the right time and the right placePatient 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 |
| non-equipped group | – | Other: It will then allow them to intervene at the right time and the right placePatient in the "non-equipped" group will have usual care |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- old subject
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Patient with a short term prognosis pathology
- In multiple bed rooms, if at least one patient does not agree with the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| It will then allow them to intervene at the right time and the right placeThe 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 | intervention group, non-equipped group |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry DANTOINE, MD study director
University Hospital, Limoges
Michel PAILLER, MD principal investigator
Gueret Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Elderly of 75 Years and Living in Nursing Homes, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The impact of the automated telesurveillance system on the risk ratio of falls (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.