Detection of Risk Behaviors: Pilot Observational Study With Bedridden and Agitated Patients.

NCT05522647 | Recruiting

• 2 other identifiers: RNI 2021 DUBOIS2021-A03099-32
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  day 9

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Bedridden and agitated patients hospitalized in a neurosurgery department

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, France

RECRUITING

MeSH Terms

Conditions

Risk-Taking; Psychomotor Agitation

Condition Hierarchy (Ancestors)

Behavior; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms

Study Officials

• Charlène DUBOIS

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 31, 2022
• Study Start: July 9, 2025
• Primary Completion (Estimated): July 9, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

FR (1)