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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04760015
Other study ID # RECHMPL21_0089
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2021
Est. completion date September 1, 2021

Study information

Verified date November 2021
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 1, 2021
Est. primary completion date August 1, 2021
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility Inclusion criteria: - aged 75 years old and more - living in nursing homes - dementia - agitation and disruptives vocalizations - twice and more interventions by the Mobile Gerontopsychiatry Team Exclusion criteria: - no follow-up after team intervention

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Efficiency of MGT's intervention on screams Evaluate the effectiveness of the MGT's intervention on cries (increase, decrease, stop, lack of effectiveness). 2 years
Secondary Determination of predictive factors for MGT's effectiveness. Determine what are the predictive factors of the effectiveness of the intervention of the MGT (time to call after onset of cries, characteristics of the patient and characteristics of the institution). 2 years
Secondary Determination if the delay between the symptom's beginning and intervention can influence their effectiveness. Determine if the delay between the onset of screaming and the intervention of the MGT has an impact on the patient's mortality. 2 years
Secondary Determination if disruptives vocalizations could be a dementia premorbid symptom. Determine whether screaming is a pre-morbid clinical sign by studying the time interval between the onset of screaming and the patient's death. 2 years
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