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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04094779
Acronym
DEMACTIFLASH
Enrollment
28
Registered
2019-09-19
Start date
2019-09-20
Completion date
2022-03-08
Last updated
2024-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Keywords

Agitation, Flash activity, Breath of fresh air

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.

Interventions

OTHERUsual 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.

OTHERFlash 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.

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of the NeuroPsychiatric Inventory Reduced (NPI-reduced) score15 minutesEvolution 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)

Secondary

MeasureTime frameDescription
Comparison of the NPI-reduced score1 hoursEvolution 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)
The Cohen-Mansfield Agitation Inventory (CMAI) score7 daysEvaluation 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)
The NPI-CT (NeuroPsychiatric Inventory Care Team version) score21 daysEvaluation 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)
Number of therapeutic strategies used18 daysNumber 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026