Risk BehaviorDECORIPAANCT05522647
Detection of Risk Behaviors: Pilot Observational Study With Bedridden and Agitated Patients.
An observational study of Risk Behavior and Agitation, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
There is a risk of falls and injuries in bedridden hospitalized patients, increased in agitated or confused patients. In neurosurgery departments, brain damaged patients can present a loss of consciousness of risky behaviors and be in a state of agitation which frequently leads to their endangerment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Risk Behavior, Agitation, Hospitalization
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jul 2025to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Bedridden and agitated patients hospitalized in a neurosurgery department
Who may be able to join
- Hospitalized in the Neurosurgery Department of the Clermont-Ferrand University Hospital
- Suffering from neurological and/or cognitive disorders leading to agitation and/or confusion
- Affiliation to a social security system
- Hospitalization in the department for at least 9 days
- Acceptance by the patient and/or trusted person capable of giving informed consent to participate in the research
Who cannot join
- Acute or transient agitation phase of somatic origin (bladder globe, pain, ionic disorder...)
- Patient under guardianship, curatorship or safeguard of justice
- Pregnant and breastfeeding women
- Refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU clermont-ferrand
Clermont-Ferrand
Lise Laclautre
Charlène DUBOIS
About this study
There is a risk of falls and injuries in bedridden hospitalized patients, increased in agitated or confused patients. In neurosurgery departments, brain damaged patients can present a loss of consciousness of risky behaviors and be in a state of agitation which frequently leads to their endangerment. The repercussions of this endangerment are multiple. For the patients, there may be a feeling of insecurity, with physical or chemical restraint solutions which deprive them of their freedom without a total guarantee of safety. For the caregivers, there is an emotional distress in front of this endangerment, and a professional guilt. Finally, there are economic repercussions due to the costs of complementary examinations and the lengthening of hospitalization.
The objective of the present study is to determine the nature and frequency of occurrence of risk behaviours, through the observation of bedridden and agitated hospitalized patients. These risk behaviours are defined as potentially dangerous and are warning signs for the caregiver. A better understanding of these behaviours could help to better anticipate falls and injuries and to implement preventive measures more quickly.
- Conditions
- Risk Behavior, Agitation, Hospitalization, Bedridden Patients
- Medical subject headings
- Risk-Taking, Psychomotor Agitation
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of risk behaviors observed per one-hour period
Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.
Measured: day 1
Number of risk behaviors observed per one-hour period
Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.
Measured: day 2
Number of risk behaviors observed per one-hour period
Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.
Measured: day 3
Number of risk behaviors observed per one-hour period
Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.
Measured: day 4
Number of risk behaviors observed per one-hour period
Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.
Measured: day 5
Number of risk behaviors observed per one-hour period
Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.
Measured: day 6
Number of risk behaviors observed per one-hour period
Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.
Measured: day 7
Number of risk behaviors observed per one-hour period
Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.
Measured: day 8
Number of risk behaviors observed per one-hour period
Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.
Measured: day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start9 Jul 2025
- Primary completion9 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk BehaviorStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlène DUBOIS, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522647
- Sponsor's protocol ID
- RNI 2021 DUBOIS
- Other IDs
- 2021-A03099-32
- Acronym
- DECORIPAA
- Status last verified
- Jul 2025
- First submitted
- 18 Aug 2022
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Risk Behaviors: Pilot Observational Study With Bedridden and Agitated Patients.
- ClinicalTrials.gov ID
- NCT05522647
- Acronym / sponsor ID
- DECORIPAA / RNI 2021 DUBOIS
- Conditions
- Risk Behavior, Agitation, Hospitalization, Bedridden Patients
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 9 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 31 Aug 2022 (actual)
- 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.
There is a risk of falls and injuries in bedridden hospitalized patients, increased in agitated or confused patients. In neurosurgery departments, brain damaged patients can present a loss of consciousness of risky behaviors and be in a state of agitation which frequently leads to their endangerment. The repercussions of this endangerment are multiple. For the patients, there may be a feeling of insecurity, with physical or chemical restraint solutions which deprive them of their freedom without a total guarantee of safety. For the caregivers, there is an emotional distress in front of this endangerment, and a professional guilt. Finally, there are economic repercussions due to the costs of complementary examinations and the lengthening of hospitalization.
The objective of the present study is to determine the nature and frequency of occurrence of risk behaviours, through the observation of bedridden and agitated hospitalized patients. These risk behaviours are defined as potentially dangerous and are warning signs for the caregiver. A better understanding of these behaviours could help to better anticipate falls and injuries and to implement preventive measures more quickly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Bedridden and agitated patients hospitalized in a neurosurgery department
Key inclusion criteria (5 listed)
- Hospitalized in the Neurosurgery Department of the Clermont-Ferrand University Hospital
- Suffering from neurological and/or cognitive disorders leading to agitation and/or confusion
- Affiliation to a social security system
- Hospitalization in the department for at least 9 days
- Acceptance by the patient and/or trusted person capable of giving informed consent to participate in the research
Key exclusion criteria (4 listed)
- Acute or transient agitation phase of somatic origin (bladder globe, pain, ionic disorder...)
- Patient under guardianship, curatorship or safeguard of justice
- Pregnant and breastfeeding women
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of risk behaviors observed per one-hour period
Time frame: day 1
Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.
Number of risk behaviors observed per one-hour period
Time frame: day 2
Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.
Number of risk behaviors observed per one-hour period
Time frame: day 3
Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.
Number of risk behaviors observed per one-hour period
Time frame: day 4
Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.
Number of risk behaviors observed per one-hour period
Time frame: day 5
Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.
Number of risk behaviors observed per one-hour period
Time frame: day 6
Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.
Number of risk behaviors observed per one-hour period
Time frame: day 7
Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.
Number of risk behaviors observed per one-hour period
Time frame: day 8
Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.
Number of risk behaviors observed per one-hour period
Time frame: day 9
Each patient will be observed for 9 one-hour time slots, each distributed over a two-hour period between 6:00 am and midnight. The number of risk behaviors will be recorded for each one-hour observation period. Observation will be for one hour per day, with the order of the time slots randomly selected.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
Charlène DUBOIS principal investigator
University Hospital, Clermont-Ferrand
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 Risk Behavior and Agitation, run by University Hospital, Clermont-Ferrand 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 14 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of risk behaviors observed per one-hour period (time frame: day 1). The study lists 9 primary outcomes in all. 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 14 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.