Effect of Breath of Fresh Air Flash Activity on Dementia Agitation : Pilot Study

Study Overview
=================
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.

Official Title
-----------------
Effect of Breath of Fresh Air Flash Activity on Dementia Agitation : Pilot Study

Conditions
-----------------
Dementia

Intervention / Treatment
-----------------
* Other: Usual relation care
* Other: Flash activity breath of fresh air


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual relational care<br>Isolate the patient from the group of other patients in order to propose to him a a relationship dual with the caregiver to the aim to calm the agitation | Other: Usual relation care<br>* When a patient begins to agitate, he will be isolated from the group to establish a dual relationship where the caregiver will try through his relational approach to calm the agitation.<br>|
| Experimental: Flash activity breath of fresh air<br>Isolate the patient from the group of other patients in order to propose to him in a relationship dual with the caregiver a physical activity outside the service that promotes relaxation by focusing his attention to the environment during 15 minutes | Other: Usual relation care<br>* When a patient begins to agitate, he will be isolated from the group to establish a dual relationship where the caregiver will try through his relational approach to calm the agitation.<br>Other: Flash activity breath of fresh air<br>* When a patient begins to agitate , he will be isolated from the group and the patient leave from the unit to walk outside with the caregiver.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the NeuroPsychiatric Inventory Reduced (NPI-reduced) score | Evolution of the score NPI-reduced agitation 15 minutes after installation of the strategy compared to the score assessed in the crisis. NPI reduced is about Gravity of the crisis from1 to 3 (1 better / 3 worse) and Impact of the crisis from 0 to 5 (0 better / 5 worse) | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the NPI-reduced score | Evolution of the score NPI-reduced agitation 1 hours after installation of the strategy compared to the score assessed in the crisis. NPI reduced is about Gravity of the crisis from1 to 3 (1 better / 3 worse) and Impact of the crisis from 0 to 5 (0 better / 5 worse) | 1 hours | 
| The Cohen-Mansfield Agitation Inventory (CMAI) score | Evaluation of the CMAI score to know the agitation level of the patient on the last 7 days with items about physical agitation and aggressivity, verbal agitation and aggressivity . From 0 to 203 (0 better / 203 worse) | 7 days | 
| The Cohen-Mansfield Agitation Inventory (CMAI) score | Evaluation of the CMAI score to know the agitation level of the patient on the last 18 days with items about physical agitation and aggressivity, verbal agitation and aggressivity . From 0 to 203 (0 better / 203 worse) | 18 days | 
| The NPI-CT (NeuroPsychiatric Inventory Care Team version) score | Evaluation oh the NPI-CT score to see the evolution of the overall intensity of behavioural disorders relative to the admission of patients. From 0 to 120 (0 better/ 120 worse) | 21 days | 
| Number of therapeutic strategies used | Number of therapeutic strategies (anxiolytics, hypnotic, neuroleptic or physical restraint) received at the outcome of an episode of agitation for which the Breath of fresh air in the experimental arm or the helping relationship in the arm control would have been insufficient | 18 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Agitation, Flash activity, Breath of fresh air