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NCT Number: NCT04094779

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

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.

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Key information

Conditions

Dementia Aberrant Motor Behavior in Dementia Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Dyskinesias Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Garonne

Toulouse, 31059, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual relation care

Other

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"

Other

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.

Primary outcomes

  1. Comparison of the NeuroPsychiatric Inventory Reduced (NPI-reduced) score

    Time frame: 15 minutes

    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)

Secondary outcomes

  1. Comparison of the NPI-reduced score

    Time frame: 1 hours

    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)

  2. The Cohen-Mansfield Agitation Inventory (CMAI) score

    Time frame: 7 days

    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)

  3. The Cohen-Mansfield Agitation Inventory (CMAI) score

    Time frame: 18 days

    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)

  4. The NPI-CT (NeuroPsychiatric Inventory Care Team version) score

    Time frame: 21 days

    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)

  5. Number of therapeutic strategies used

    Time frame: 18 days

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: DEMACTIFLASH

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 19, 2019
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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