DementiaNCT04760015
Characteristics of Patients With Dementia Who Are Screaming in Nursing Homes
An observational study of Dementia, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Dementia
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2021to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Residents in nursing homes, aged 75 years old and more. They have dementia with agitation, including diruptives vocalizations.
Who may be able to join
- aged 75 years old and more
- living in nursing homes
- dementia
- agitation and disruptives vocalizations
- twice and more interventions by the Mobile Gerontopsychiatry Team
Who cannot join
- no follow-up after team intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characteristics of Patients With Disruptive Vocalizations Residing in Nursing Homes Supported by the Mobile Gerontopsychiatry Team : Retrospective Study
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.
- Conditions
- Dementia
- Keywords
- Dementia disease, Disruptives vocalizations, agitation, cries, profil, characteristics
- Medical subject headings
- Dementia, Psychomotor Agitation
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 years
Secondary outcomes (4)
Efficiency of MGT's intervention on screams
Evaluate the effectiveness of the MGT's intervention on cries (increase, decrease, stop, lack of effectiveness).
Measured: 2 years
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).
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Feb 2021
- Primary completion1 Aug 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Suzanne Leglise, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760015
- Sponsor's protocol ID
- RECHMPL21_0089
- Status last verified
- Nov 2021
- First submitted
- 15 Feb 2021
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Patients With Disruptive Vocalizations Residing in Nursing Homes Supported by the Mobile Gerontopsychiatry Team : Retrospective Study
- ClinicalTrials.gov ID
- NCT04760015
- Acronym / sponsor ID
- RECHMPL21_0089
- Conditions
- Dementia
- Keywords
- Dementia disease, Disruptives vocalizations, agitation, cries, profil, characteristics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Residents in nursing homes, aged 75 years old and more. They have dementia with agitation, including diruptives vocalizations.
Key inclusion criteria (5 listed)
- aged 75 years old and more
- living in nursing homes
- dementia
- agitation and disruptives vocalizations
- twice and more interventions by the Mobile Gerontopsychiatry Team
Key exclusion criteria (1 listed)
- no follow-up after team intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Describe the profile of demented patients
Time frame: 2 years
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).
4 secondary outcomes
Efficiency of MGT's intervention on screams
Time frame: 2 years
Determination of predictive factors for MGT's effectiveness.
Time frame: 2 years
Determination if the delay between the symptom's beginning and intervention can influence their effectiveness.
Time frame: 2 years
Determination if disruptives vocalizations could be a dementia premorbid symptom.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Suzanne Leglise, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the profile of demented patients (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.