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

Dementia Clinical Trial

— DEMACTIFLASH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04094779
• Other study ID #: RC31/17/0348
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2019
• Est. completion date: October 31, 2022

Study information

• Verified date: June 2022
• Source: University Hospital, Toulouse
• Contact: Aneta BARTUSIAK
• Phone: 0534557444
• Email: bartusiak.aneta[@]yahoo.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 31, 2022
• Est. primary completion date: October 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Psychomotor Agitation

Intervention

Other:
• Usual relation care
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.
• Flash activity "breath of fresh air"
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.

Locations

Country	Name	City	State
France	Hôpital Garonne	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

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