NCT04760015

Brief Summary

Patients with dementia develop behavioral problems over time. Among these, the investigators object screams or cries or disruptives vocalizations. Their cause is multifactorial and their management difficult in nursing homes. Often this patients are polymedicated, sedated or/and isolated. Many scientific studies are interested in drug and non-drug treatments. In this study, the investigators are looking for a profile for disruptives vocalizations's patients. Thus, the investigators will study the global profile of demented patients residing in EHPAD to determine if there are any similarities between them.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

November 15, 2021

Status Verified

November 1, 2021

Enrollment Period

6 months

First QC Date

February 15, 2021

Last Update Submit

November 12, 2021

Conditions

Keywords

Dementia diseaseDisruptives vocalizationsagitationcriesprofilcharacteristics

Outcome Measures

Primary Outcomes (1)

  • Describe the profile of demented patients

    Describe the profile of demented patients with disruptives vocalizations in EHPAD aged 75 and over, for whom an intervention of the Mobile Gerontopsychiatry Team (MGT) is requested. Determining the profile of the screaming residents in nursing home : age, sex, type of dementia, severity of dementia (MMSE score), co-morbidities, current treatments, sensory impairments, autonomy, environment (visits, outside workers, activities in the EHPAD, paramedical interventions, …), NPI-ES, psychological state (GDS).

    2 years

Secondary Outcomes (4)

  • Efficiency of MGT's intervention on screams

    2 years

  • Determination of predictive factors for MGT's effectiveness.

    2 years

  • Determination if the delay between the symptom's beginning and intervention can influence their effectiveness.

    2 years

  • Determination if disruptives vocalizations could be a dementia premorbid symptom.

    2 years

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Residents in nursing homes, aged 75 years old and more. They have dementia with agitation, including diruptives vocalizations.

You may qualify if:

  • aged 75 years old and more
  • living in nursing homes
  • dementia
  • agitation and disruptives vocalizations
  • twice and more interventions by the Mobile Gerontopsychiatry Team

You may not qualify if:

  • \- no follow-up after team intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, 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

  • Marie-Suzanne Leglise, MD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2021

First Posted

February 18, 2021

Study Start

February 1, 2021

Primary Completion

August 1, 2021

Study Completion

September 1, 2021

Last Updated

November 15, 2021

Record last verified: 2021-11

Locations