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

September 23, 2024 updated by: University Hospital, Toulouse

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
        • Hôpital Garonne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual relational care
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
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.
Experimental: Flash activity "breath of fresh air"
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
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 hours
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)
7 days
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)
18 days
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)
21 days
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
18 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Aneta BARTUSIAK, CHU Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2019

Primary Completion (Actual)

March 8, 2022

Study Completion (Actual)

March 8, 2022

Study Registration Dates

First Submitted

September 13, 2019

First Submitted That Met QC Criteria

September 16, 2019

First Posted (Actual)

September 19, 2019

Study Record Updates

Last Update Posted (Actual)

September 25, 2024

Last Update Submitted That Met QC Criteria

September 23, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/17/0348

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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