NCT04094779

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

September 20, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2022

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

2.5 years

First QC Date

September 13, 2019

Last Update Submit

September 23, 2024

Conditions

Dementia

Keywords

AgitationFlash activityBreath of fresh air

Outcome Measures

Primary Outcomes (1)

  • 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)

    15 minutes

Secondary Outcomes (5)

  • Comparison of the NPI-reduced score

    1 hours

  • The Cohen-Mansfield Agitation Inventory (CMAI) score

    7 days

  • The Cohen-Mansfield Agitation Inventory (CMAI) score

    18 days

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

    21 days

  • Number of therapeutic strategies used

    18 days

Study Arms (2)

Usual relational care

ACTIVE COMPARATOR

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

Flash activity "breath of fresh air"

EXPERIMENTAL

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 careOther: Flash activity "breath of fresh air"

Interventions

Usual relation careOTHER

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"Usual relational care
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.

Flash activity "breath of fresh air"

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Absence of agitation
  • Juveniles
  • Pregnant women
  • Patient who has previously participated in the study
  • Persons under protection of justice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Garonne

Toulouse, 31059, France

Location

MeSH Terms

Conditions

DementiaPsychomotor Agitation

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersDyskinesiasNeurologic ManifestationsPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Study Officials

  • Aneta BARTUSIAK

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2019

First Posted

September 19, 2019

Study Start

September 20, 2019

Primary Completion

March 8, 2022

Study Completion

March 8, 2022

Last Updated

September 25, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)