Dementia in Nursing HomeIDEMNCT01569997
Impact of Systematic Tracking of Dementia Cases on the Rate of Hospitalization in Emergency Care Units
A study testing MultiDisciplinary Team Meetings (MDTM) in people with Dementia in Nursing Home, run by University Hospital, Toulouse at 90 sites in France.
Trial summary
Introduction: Epidemiological data show that in France only half of patients with Alzheimer disease are currently diagnosed in the general population. The absence of early diagnosis of dementia reduces the opportunities of patients to receive optimal care. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia in Nursing Home
- What is being tested?
- MultiDisciplinary Team Meetings (MDTM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,428 participants
- Where
- 90 sitesFrance
- Study dates
- May 2010to Sep 2013
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Residents of both sex, aged 60 years or over
- Residents living in a nursing home participating in the study
- Residents living in the nursing home for 30 days or more
- Residents without diagnosed and documented dementia, identified as follows:
- residents not identified by the French Healthcare system as suffering from dementia (ALD 15)
- residents not benefiting from a specific care program or a specialized follow-up for dementia
Show all 10Show fewer
- residents for whom there is no appropriate investigation for dementia diagnosis in medical records
- residents not taking specific drugs for dementia (Cholinesterase inhibitors and/or Memantine)
- Residents and their GP having received information about the study
- Residents and their GP having expressed their agreement to participate in the study
Who cannot join
- Residents aged less than 60 years
- Residents not living in a nursing home participating in study
- Residents living in nursing home for less than 30 days
- Residents with diagnosed and documented dementia, identified as follows:
- residents Identified by the French Healthcare system as suffering from dementia (ALD 15)
- residents benefiting from specific care programme or specialized follow-up for dementia
Show all 10Show fewer
- residents for whom there is appropriate investigation for dementia diagnosis in medical records
- residents taking specific drugs for dementia (Cholinesterase inhibitors and/or Memantine)
- Residents and/or their GP who received no information about the study
- Residents and/or their GP having expressed their opposition to participate in the study
Trial locations and contacts
90 sites in 1 country.
90 sites in 1 country
France90 sites
Centre de Gerontologie Pompeyrie Chu Agen
Agen
Ehpad Maison de Retraite Louise Anceau
Albi
Ehpad Maison de Retraite Olga Ducoudray
Albi
Ehpad Mr "Les Jardins de Jouvence"
Albi
Mapad La Renaudie Ch Albi
Albi
Ehpad Les Ajoncs D'Or
Allaire
Ehpad Maison de Retraite Hl Ax Les Thermes
Ax-les-Thermes
Ehpad Marie Lehman
Balma
Ehpad Kerdigemer
Brest
Ehpad Residence Ker-Heol
Brest
Ehpad Residence Saint Astier
Catus
Mapa de L'Hopital Local de Caussade
Caussade
Ehpad Maison de Retraite Ste Marthe
Ceignac
EHPAD Résidence Castelgirou
Cépet
Ehpad Leon Ronzier Joly
Clermont-l'Hérault
Ehpad Themis Lasplanes
Colomiers
Ehpad Maison de Retraite Joseph Sauvy
Err
Ehpad Residence Borde Haute Promo-Accueil
Escalquens
Mapad "Firmi"
Firmi
Ehpad Hopital Local Fleurance
Fleurance
Ehpad Mr Bellissen Chi Du Val D'Ariege
Foix
Ehpad Dr Robert
Guer
Ehpad Residence Grand'Maison
L'Union
Ehpad Residence Provencale Medicafrance
La Roquebrussanne
Ehpad Residence Clairefontaine
Lamorlaye
Mapad Ch Lavaur
Lavaur
Ehpad Saint Reah Hir
Le Conquet
Ehpad Residence D'Automne de La Ferme
Le Mée-sur-Seine
Ehpad Maison de Retraite "Les Charmilles"
Lescure-d'Albigeois
Residence Le Parc
Lézat-sur-Lèze
Ehpad La Cheneraie
Lherm
Ehpad Mr Lagrange
Lisle-sur-Tarn
Mapad Labastide Ch Lourdes
Lourdes
Ehpad Emile Dubois
Marchiennes
Ehpad Les Mille Soleils
Marciac
Ehpad Et. Public Gerontologie de Marines
Marines
AP-HM Hôptal La Timone Service de Pédiatrie Mutidisciplinaire
Marseille, 13385
Ehpad Maison Retraite Hl Mauvezin
Mauvezin
Ehpad Maison de Retraite Saint Joseph
Mazamet
Ehpad Maison de Retraite Privee de Mazeres
Mazères
Ehpad L'Ecrin Des Sages
Mèze
Ehpad-Maison Retraite Hl Mirande
Mirande
Ehpad Chis Castelsarrasin-Moissac
Moissac
Ehpad Maison Retraite Ch Montauban
Montauban
Ehpad Era Caso
Montauban-de-Luchon
Ehpad Ma Maison
Montpellier
Ehpad Maison de Retraite Sainte Agnes
Montredon-Labessonnié
Ehpad L'Acacia
Nailloux
Logements Foyer La Fontanelle
Naucelle
Ehpad Fondation Pauliani
Nice
Ehpad Les Noisetiers
Nice
Ehpad Residence Ancilla
Nice
Ehpad Mais de Retraite Saint-Joseph
Ossun
Ehpad Mr Bariol Chi Du Val D'Ariege
Pamiers
Ehpad Residence Le Parc
Panazol
AP-HP Hôpital Necker Enfants Malades Service d'endocrinologie pédiatrique - 149 route de Sèvres
Paris, 75015
Ehpad Furtado Heine
Paris
Ehpad Julie Siegfried
Paris
Ehpad La Pirandelle
Paris
Ehpad Residence Anselme
Paris
Ehpad Residence Belleville
Paris
Ehpad Residence Herold
Paris
Ehpad Residence Oceane
Paris
Ehpad Tiers Temps Paris
Paris
Ehpad Residence Adeline
Pierre-Buffière
Ehpad Residence D'Automne Medica-France
Reims
Ehpad L'Oree Du Bois
Rieux-Volvestre
Ehpad Residence Saint-Amans
Rodez
Ehpad Le Jardin Des Loges
Saint-Bonnet
Ehpad Maison Retraite Orelia Ch St Gaudens
Saint-Gaudens
Ehpad Residence Themis La Joie de Vivre
Saint-Lys
Ehpad Genevriers
Saint-Martory
Ehpad A Labouilhe
Saint-Orens-de-Gameville
Ehpad Public de Saint-Remy de Provence
Saint-Rémy-de-Provence
Ehpad Les Bruyeres
Sousceyrac
Ehpad Maison de Retraite Chic Tarbes Vic
Tarbes
Ehpad Residence "Le Doyenne Du Carmel"
Tarbes
Ehpad Sainte Anne
Tinténiac
Ehpad de La Cote Pavee
Toulouse
Ehpad Gaubert
Toulouse
Ehpad Mr Henri Iv
Toulouse
Ehpad Pierre Ducis
Toulouse
Ehpad Residence La Cotonniere
Toulouse
Ehpad Residence Le Clos Des Carmes
Toulouse
Ehpad Residence Marguerite
Toulouse
Ehpad Residence Saint-Simon
Toulouse
Usld Domaine de La Cadene
Toulouse
Ehpad Umt
Valence-d'Albigeois
Ehpad Maisonneuve
Villefranche-de-Lauragais
Ehpad Saint-Jacques
Villemur-sur-Tarn
About this study
Official title: Interest of Systematic Tracking of Dementia Cases in Nursing Homes: Analysing the Contribution of MultiDisciplinary Team Meeting (MDTM) in Alzheimer's Disease and Related Diseases
Introduction: Epidemiological data show that in France only half of patients with Alzheimer disease are currently diagnosed in the general population. The absence of early diagnosis of dementia reduces the opportunities of patients to receive optimal care. One of the consequences of undiagnosed dementia is inadequate use of emergency care units.
The main objective: The main aim of this study is to evaluate the impact of a systematic case-finding procedure of dementia cases in nursing homes through a MDTM on the rate of hospitalization in emergency care units.
Read more
Secondary objectives:
To assess the impact of systematic tracking of dementia cases on the:
- Quantity and quality of drug-prescription
- Appropriateness of hospitalizations
- Prevalence of neuropsychiatric symptoms
- Dependency
- Quality of life
- Burden of nursing staff working conditions
- Planning of specific therapeutic measures
- Overall health care costs
Read the detailed description
This is a multicentre, cluster randomized study comparing two parallel groups:
- Intervention group: nursing homes whose residents benefit from MDTM to identify the cases of dementia and to propose an adequate care project
- Control group: nursing homes whose residents continue to benefit from usual care In each group, 1000 elderly subjects aged over 60 years without documented diagnosis of dementia will be included and monitored for a period of 18 months.
Information about the main and secondary aims will be collected monthly through online questionnaires.
- Conditions
- Dementia in Nursing Home
- Being tested
- MultiDisciplinary Team Meetings (MDTM)
- Keywords
- Dementia, emergency hospitalization, nursing home, multidisciplinary meeting, cognitive decline, disability, residents, facilities, long term care unit, health policy, general practitioner, prevention
- Medical subject headings
- Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MultiDisciplinary Team Meetings (MDTM)Other
The MDTM, between the memory experts and Nursing Home coordinating practitioners, could help the nursing home medical staff identify the cases of dementia and propose these residents an adequate healthcare project (supplementary investigations, therapeutic modifications, hospitalizations...)
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Other | Intervention group: nursing homes whose residents benefit from MDTM to identify the cases of dementia and to propose an adequate care project Receives: Other: MultiDisciplinary Team Meetings (MDTM) |
| control group | No intervention | Control group: nursing homes whose residents continue to benefit from usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hospitalizations in emergency care units
Monthly collection during follow-up (18 months)
Measured: 18 months
Secondary outcomes (9)
Prevalence of antipsychotic prescription
Measured: Baseline visit, 4 months, 18 months
Incidence of inappropriate hospitalizations
Monthly collection during follow-up (18 months)
Measured: 18 months
Prevalence of neuropsychiatric symptoms evaluated by NPI-nursing staff version
Measured: Baseline visit, 18 months
Dependency evaluated by AGGIR and IADL-4 items
Measured: Baseline visit, 18 months
Quality of life evaluated by QOL-AD
Measured: Baseline visit, 18 months
Number of nursing staff's time off work
Monthly collection during follow-up (18 months)
Measured: 18 months
Number of days off work by nursing staff
Monthly collection during follow-up (18 months)
Measured: 18 months
Presence of advanced care planning in patients medical records
Advanced care planning will be checked through behavioural disosders, transfer to hospital intensive care and resuscitation
Measured: Baseline visit, 18 months
Overall healthcare costs
Monthly collection during follow-up (18 months)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startMay 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dementia in Nursing HomeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,428 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre ALLAN, MD, Principal investigator, EHPAD MAISON DE RETRAITE SAINT JOSEPH - MAZAMETVéronique ARNAUD-ULLIET, MD, Principal investigator, EHPAD MA MAISON MONTPELLIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569997
- Sponsor's protocol ID
- 0910701
- Other IDs
- 2009-A01062-55
- Acronym
- IDEM
- Status last verified
- Jul 2020
- First submitted
- 4 Jul 2011
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Rolland Y, Tavassoli N, de Souto Barreto P, Perrin A, Laffon de Mazieres C, Rapp T, Hermabessiere S, Tournay E, Vellas B, Andrieu S. Systematic Dementia Screening by Multidisciplinary Team Meetings in Nursing Homes for Reducing Emergency Department Transfers: The IDEM Cluster Randomized Clinical Trial. JAMA Netw Open. 2020 Feb 5;3(2):e200049. doi: 10.1001/jamanetworkopen.2020.0049.
PubMed 32101308
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Systematic Tracking of Dementia Cases in Nursing Homes: Analysing the Contribution of MultiDisciplinary Team Meeting (MDTM) in Alzheimer's Disease and Related Diseases
- ClinicalTrials.gov ID
- NCT01569997
- Acronym / sponsor ID
- IDEM / 0910701
- Conditions
- Dementia in Nursing Home
- Keywords
- Dementia, emergency hospitalization, nursing home, multidisciplinary meeting, cognitive decline, disability, residents, facilities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,428 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 4 Apr 2012 (estimated)
- 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.
Introduction: Epidemiological data show that in France only half of patients with Alzheimer disease are currently diagnosed in the general population. The absence of early diagnosis of dementia reduces the opportunities of patients to receive optimal care. One of the consequences of undiagnosed dementia is inadequate use of emergency care units.
The main objective: The main aim of this study is to evaluate the impact of a systematic case-finding procedure of dementia cases in nursing homes through a MDTM on the rate of hospitalization in emergency care units.
Secondary objectives:
To assess the impact of systematic tracking of dementia cases on the:
- Quantity and quality of drug-prescription
- Appropriateness of hospitalizations
- Prevalence of neuropsychiatric symptoms
- Dependency
- Quality of life
- Burden of nursing staff working conditions
- Planning of specific therapeutic measures
- Overall health care costs
Detailed description
This is a multicentre, cluster randomized study comparing two parallel groups:
- Intervention group: nursing homes whose residents benefit from MDTM to identify the cases of dementia and to propose an adequate care project
- Control group: nursing homes whose residents continue to benefit from usual care In each group, 1000 elderly subjects aged over 60 years without documented diagnosis of dementia will be included and monitored for a period of 18 months.
Information about the main and secondary aims will be collected monthly through online questionnaires.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Other | Other: MultiDisciplinary Team Meetings (MDTM)Intervention group: nursing homes whose residents benefit from MDTM to identify the cases of dementia and to propose an adequate care project |
| control group | No intervention | –Control group: nursing homes whose residents continue to benefit from usual care |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Residents of both sex, aged 60 years or over
- Residents living in a nursing home participating in the study
- Residents living in the nursing home for 30 days or more
- Residents without diagnosed and documented dementia, identified as follows:
- Residents and their GP having received information about the study
Key exclusion criteria (10 listed)
- Residents aged less than 60 years
- Residents not living in a nursing home participating in study
- Residents living in nursing home for less than 30 days
- Residents with diagnosed and documented dementia, identified as follows:
- Residents and/or their GP who received no information about the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MultiDisciplinary Team Meetings (MDTM)The MDTM, between the memory experts and Nursing Home coordinating practitioners, could help the nursing home medical staff identify the cases of dementia and propose these residents an adequate healthcare project (supplementary investigations, therapeutic modifications, hospitalizations...) | Other | Intervention group |
Primary outcome
Incidence of hospitalizations in emergency care units
Time frame: 18 months
Monthly collection during follow-up (18 months)
9 secondary outcomes
Prevalence of antipsychotic prescription
Time frame: Baseline visit, 4 months, 18 months
Incidence of inappropriate hospitalizations
Time frame: 18 months
Prevalence of neuropsychiatric symptoms evaluated by NPI-nursing staff version
Time frame: Baseline visit, 18 months
Dependency evaluated by AGGIR and IADL-4 items
Time frame: Baseline visit, 18 months
Quality of life evaluated by QOL-AD
Time frame: Baseline visit, 18 months
Number of nursing staff's time off work
Time frame: 18 months
Number of days off work by nursing staff
Time frame: 18 months
Presence of advanced care planning in patients medical records
Time frame: Baseline visit, 18 months
Overall healthcare costs
Time frame: 18 months
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 29 Jul 2020.
- Results publication: PubMed 32101308Rolland Y, Tavassoli N, de Souto Barreto P, Perrin A, Laffon de Mazieres C, Rapp T, Hermabessiere S, Tournay E, Vellas B, Andrieu S. Systematic Dementia Screening by Multidisciplinary Team Meetings in Nursing Homes for Reducing Emergency Department Transfers: The IDEM Cluster Randomized Clinical Trial. JAMA Netw Open. 2020 Feb 5;3(2):e200049. doi: 10.1001/jamanetworkopen.2020.0049.
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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.
Pierre ALLAN, MD principal investigator
EHPAD MAISON DE RETRAITE SAINT JOSEPH - MAZAMET
Véronique ARNAUD-ULLIET, MD principal investigator
EHPAD MA MAISON MONTPELLIER
90 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MultiDisciplinary Team Meetings (MDTM) in people with Dementia in Nursing Home, run by University Hospital, Toulouse at 90 sites 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 10 inclusion and 10 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 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 90 sites 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?
Incidence of hospitalizations in emergency care units (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01569997, which also lists 1 linked publication.
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 29 Jul 2020.