Clinical trial NCT04094779: Effect of "breath of Fresh Air" Flash Activity on Dementia Agitation : Pilot Study
Official title: Effect of "breath of Fresh Air" Flash Activity on Dementia Agitation : Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Agitation
Flash activity
Breath of fresh air
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Non-drug therapies (NDT) constitute a strong axis of the person with dementia behaviour management. Among these NDT, the flash activities constitute a mode of intervention to prevent and control the expression of the most disruptive behavior. These are short-term activities with the objective of decreasing the behavioural disorders intensity in less than 15 minutes.

The aim of this pilot study is to test the effect of a flash activity "breath of fresh air" compared to the usual relational care on the short-term decrease (15 min.) of the agitation in hospitalized dementia patients.

Detailed description: The "breath of fresh air" flash strategy is to offer the patient the possibility to go out of the medical unity and walking outdoor.

When the caregiver identify a level of agitation greater or equal to two on the gravity score and greater or equal to two on the impact score with the NPI test (The Neuropsychiatric Inventory Test), the caregiver let the patient wandering in the outside lanes of the hospital and encourage him to us his senses. For example, the sight could be stimulated by looking at a bird.

This variation of sensory stimulations enable a temporo-sensory break on the crisis, allowing the patient to turn his attention from the crisis context to another stimulation.

Eligibility criteria: Inclusion Criteria:

* New patients admitted in the unit to the management of the Psychological and Behavioural Symptoms of Dementia
* Dementia regardless of etiology and severity
* Score greater than 2 than NPI established on entry into service
* Free, informed and written consent signed by the person trust and/or family member and/or legal representative
* Health insurance membership

Exclusion Criteria:

* Absence of agitation
* Juveniles
* Pregnant women
* Patient who has previously participated in the study
* Persons under protection of justice

Primary outcomes:
measure: Comparison of the NeuroPsychiatric Inventory Reduced (NPI-reduced) score
timeFrame: 15 minutes
Secondary outcomes:
measure: Comparison of the NPI-reduced score
timeFrame: 1 hours
measure: The Cohen-Mansfield Agitation Inventory (CMAI) score
timeFrame: 7 days
measure: The Cohen-Mansfield Agitation Inventory (CMAI) score
timeFrame: 18 days
measure: The NPI-CT (NeuroPsychiatric Inventory Care Team version) score
timeFrame: 21 days
measure: Number of therapeutic strategies used
timeFrame: 18 days
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Hôpital Garonne
Study officials:
affiliation: CHU Toulouse
name: Aneta BARTUSIAK
role: PRINCIPAL_INVESTIGATOR
References: