Effect of "Breath of Fresh Air" Flash Activity on Dementia Agitation : Pilot Study (DEMACTIFLASH)
Primary Purpose
Dementia
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Usual relation care
Flash activity "breath of fresh air"
Sponsored by
About this trial
This is an interventional other trial for Dementia focused on measuring Agitation, Flash activity, Breath of fresh air
Eligibility Criteria
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
Sites / Locations
- Hôpital GaronneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Usual relational care
Flash activity "breath of fresh air"
Arm 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
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
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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)
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)
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)
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
Full Information
NCT ID
NCT04094779
First Posted
September 13, 2019
Last Updated
June 8, 2022
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT04094779
Brief Title
Effect of "Breath of Fresh Air" Flash Activity on Dementia Agitation : Pilot Study
Acronym
DEMACTIFLASH
Official Title
Effect of "Breath of Fresh Air" Flash Activity on Dementia Agitation : Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2019 (Actual)
Primary Completion Date
October 20, 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Agitation, Flash activity, Breath of fresh air
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual relational care
Arm Type
Active Comparator
Arm 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
Arm Title
Flash activity "breath of fresh air"
Arm Type
Experimental
Arm 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
Intervention Type
Other
Intervention Name(s)
Usual relation care
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Flash activity "breath of fresh air"
Intervention Description
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 Outcome Measure Information:
Title
Comparison of the NeuroPsychiatric Inventory Reduced (NPI-reduced) score
Description
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)
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Comparison of the NPI-reduced score
Description
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)
Time Frame
1 hours
Title
The Cohen-Mansfield Agitation Inventory (CMAI) score
Description
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)
Time Frame
7 days
Title
The Cohen-Mansfield Agitation Inventory (CMAI) score
Description
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)
Time Frame
18 days
Title
The NPI-CT (NeuroPsychiatric Inventory Care Team version) score
Description
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)
Time Frame
21 days
Title
Number of therapeutic strategies used
Description
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
Time Frame
18 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aneta BARTUSIAK
Phone
0534557444
Ext
+33
Email
bartusiak.aneta@yahoo.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Chantal BONNAFOUS
Phone
0534557442
Ext
+33
Email
bonnafous.chantal@orange.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aneta BARTUSIAK
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Garonne
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aneta BARTUSIAK
Phone
0534557442
Ext
+33
Email
bartusiak.aneta@yahoo.fr
First Name & Middle Initial & Last Name & Degree
Chantal BONNAFOUS
Phone
0534557442
Ext
+33
Email
bonnafous.chantal@orange.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of "Breath of Fresh Air" Flash Activity on Dementia Agitation : Pilot Study
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