ClinicalTrials.Veeva

Menu

Effect of "breath of Fresh Air" Flash Activity on Dementia Agitation : Pilot Study (DEMACTIFLASH)

T

Toulouse University Hospital

Status

Completed

Conditions

Dementia

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04094779
RC31/17/0348

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

28 participants in 2 patient groups

Usual relational care
Active Comparator group
Description:
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
Treatment:
Other: Usual relation care
Flash activity "breath of fresh air"
Experimental group
Description:
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
Treatment:
Other: Flash activity "breath of fresh air"
Other: Usual relation care

Trial contacts and locations

1

Loading...

Central trial contact

Chantal BONNAFOUS; Aneta BARTUSIAK

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems