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NCT Number: NCT05522647

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

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.

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Key information

Conditions

Risk Behavior Aberrant Motor Behavior in Dementia Agitation Bedridden Patients Behavior Behavioral Symptoms Dyskinesias Hospitalization Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Risk-Taking Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU clermont-ferrand

Clermont-Ferrand, France

Location status: Recruiting

Location contact

Charlène DUBOIS

PRINCIPAL_INVESTIGATOR

Lise Laclautre

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

334.73.754.963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: DECORIPAA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 31, 2022
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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