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

Agitation Clinical Trial

— DECORIPAA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05522647
• Other study ID #: RNI 2021 DUBOIS
• Secondary ID: 2021-A03099-32
• Status: Not yet recruiting
• Start date: September 1, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: July 2022
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 334.73.754.963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Agitation
• Hospitalization
• Psychomotor Agitation
• Risk Behavior

Locations

Country	Name	City	State
France	CHU clermont-ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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