- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01569997
Impact of Systematic Tracking of Dementia Cases on the Rate of Hospitalization in Emergency Care Units (IDEM)
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.
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Agen, France
- Centre de Gerontologie Pompeyrie Chu Agen
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Albi, France
- Ehpad Maison de Retraite Louise Anceau
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Albi, France
- Ehpad Maison de Retraite Olga Ducoudray
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Albi, France
- Ehpad Mr "Les Jardins de Jouvence"
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Albi, France
- Mapad La Renaudie Ch Albi
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Allaire, France
- Ehpad Les Ajoncs D'Or
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Ax-les-Thermes, France
- Ehpad Maison de Retraite Hl Ax Les Thermes
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Balma, France
- Ehpad Marie Lehman
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Brest, France
- Ehpad Kerdigemer
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Brest, France
- Ehpad Residence Ker-Heol
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Catus, France
- Ehpad Residence Saint Astier
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Caussade, France
- Mapa de L'Hopital Local de Caussade
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Ceignac, France
- Ehpad Maison de Retraite Ste Marthe
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Cepet, France
- EHPAD Résidence Castelgirou
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Clermont L'herault, France
- Ehpad Leon Ronzier Joly
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Colomiers, France
- Ehpad Themis Lasplanes
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ERR, France
- Ehpad Maison de Retraite Joseph Sauvy
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Escalquens, France
- Ehpad Residence Borde Haute Promo-Accueil
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Firmi, France
- Mapad "Firmi"
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Fleurance, France
- Ehpad Hopital Local Fleurance
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Foix, France
- Ehpad Mr Bellissen Chi Du Val D'Ariege
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Guer, France
- Ehpad Dr Robert
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L'union, France
- Ehpad Residence Grand'Maison
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La Roquebrussanne, France
- Ehpad Residence Provencale Medicafrance
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Lamorlaye, France
- Ehpad Residence Clairefontaine
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Lavaur, France
- Mapad Ch Lavaur
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Le Conquet, France
- Ehpad Saint Reah Hir
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Le Mee Sur Seine, France
- Ehpad Residence D'Automne de La Ferme
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Lescure d'Albigeois, France
- Ehpad Maison de Retraite "Les Charmilles"
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Lezat Sur Leze, France
- Residence Le Parc
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Lherm, France
- Ehpad La Cheneraie
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Lisle Sur Tarn, France
- Ehpad Mr Lagrange
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Lourdes, France
- Mapad Labastide Ch Lourdes
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Marchiennes, France
- Ehpad Emile Dubois
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Marciac, France
- Ehpad Les Mille Soleils
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Marines, France
- Ehpad Et. Public Gerontologie de Marines
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Marseille, France, 13385
- AP-HM Hôptal La Timone Service de Pédiatrie Mutidisciplinaire
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Mauvezin, France
- Ehpad Maison Retraite Hl Mauvezin
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Mazamet, France
- Ehpad Maison de Retraite Saint Joseph
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Mazeres, France
- Ehpad Maison de Retraite Privee de Mazeres
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Mirande, France
- Ehpad-Maison Retraite Hl Mirande
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Moissac, France
- Ehpad Chis Castelsarrasin-Moissac
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Montauban, France
- Ehpad Maison Retraite Ch Montauban
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Montauban de Luchon, France
- Ehpad Era Caso
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Montpellier, France
- Ehpad Ma Maison
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Montredon Labessonnie, France
- Ehpad Maison de Retraite Sainte Agnes
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Mèze, France
- Ehpad L'Ecrin Des Sages
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Nailloux, France
- Ehpad L'Acacia
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Naucelle, France
- Logements Foyer La Fontanelle
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Nice, France
- Ehpad Fondation Pauliani
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Nice, France
- Ehpad Les Noisetiers
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Nice, France
- Ehpad Residence Ancilla
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Ossun, France
- Ehpad Mais de Retraite Saint-Joseph
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Pamiers, France
- Ehpad Mr Bariol Chi Du Val D'Ariege
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Panazol, France
- Ehpad Residence Le Parc
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Paris, France, 75015
- AP-HP Hôpital Necker Enfants Malades Service d'endocrinologie pédiatrique - 149 route de Sèvres
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Paris, France
- Ehpad Furtado Heine
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Paris, France
- Ehpad Julie Siegfried
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Paris, France
- Ehpad La Pirandelle
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Paris, France
- Ehpad Residence Anselme
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Paris, France
- Ehpad Residence Belleville
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Paris, France
- Ehpad Residence Herold
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Paris, France
- Ehpad Residence Oceane
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Paris, France
- Ehpad Tiers Temps Paris
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Pierre Buffiere, France
- Ehpad Residence Adeline
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Reims, France
- Ehpad Residence D'Automne Medica-France
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Rieux Volvestre, France
- Ehpad L'Oree Du Bois
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Rodez, France
- Ehpad Residence Saint-Amans
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Saint Bonnet, France
- Ehpad Le Jardin Des Loges
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Saint Lys, France
- Ehpad Residence Themis La Joie de Vivre
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Saint Orens de Gameville, France
- Ehpad A Labouilhe
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Saint Remy de Provence, France
- Ehpad Public de Saint-Remy de Provence
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Sousceyrac, France
- Ehpad Les Bruyeres
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St Gaudens, France
- Ehpad Maison Retraite Orelia Ch St Gaudens
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St Martory, France
- Ehpad Genevriers
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Tarbes, France
- Ehpad Maison de Retraite Chic Tarbes Vic
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Tarbes, France
- Ehpad Residence "Le Doyenne Du Carmel"
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Tinteniac, France
- Ehpad Sainte Anne
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Toulouse, France
- Ehpad de La Cote Pavee
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Toulouse, France
- Ehpad Gaubert
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Toulouse, France
- Ehpad Mr Henri Iv
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Toulouse, France
- Ehpad Pierre Ducis
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Toulouse, France
- Ehpad Residence La Cotonniere
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Toulouse, France
- Ehpad Residence Le Clos Des Carmes
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Toulouse, France
- Ehpad Residence Marguerite
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Toulouse, France
- Ehpad Residence Saint-Simon
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Toulouse, France
- Usld Domaine de La Cadene
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Valence-d'albigeois, France
- Ehpad Umt
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Villefranche de Lauragais, France
- Ehpad Maisonneuve
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Villemur Sur Tarn, France
- Ehpad Saint-Jacques
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Intervention group
Intervention group: nursing homes whose residents benefit from MDTM to identify the cases of dementia and to propose an adequate care project
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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...)
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No Intervention: control group
Control group: nursing homes whose residents continue to benefit from usual care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of hospitalizations in emergency care units
Time Frame: 18 months
|
Monthly collection during follow-up (18 months)
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of antipsychotic prescription
Time Frame: Baseline visit, 4 months, 18 months
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Baseline visit, 4 months, 18 months
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Incidence of inappropriate hospitalizations
Time Frame: 18 months
|
Monthly collection during follow-up (18 months)
|
18 months
|
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Prevalence of neuropsychiatric symptoms evaluated by NPI-nursing staff version
Time Frame: Baseline visit, 18 months
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Baseline visit, 18 months
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Dependency evaluated by AGGIR and IADL-4 items
Time Frame: Baseline visit, 18 months
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Baseline visit, 18 months
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Quality of life evaluated by QOL-AD
Time Frame: Baseline visit, 18 months
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Baseline visit, 18 months
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Number of nursing staff's time off work
Time Frame: 18 months
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Monthly collection during follow-up (18 months)
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18 months
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Number of days off work by nursing staff
Time Frame: 18 months
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Monthly collection during follow-up (18 months)
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18 months
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Presence of advanced care planning in patients medical records
Time Frame: Baseline visit, 18 months
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Advanced care planning will be checked through behavioural disosders, transfer to hospital intensive care and resuscitation
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Baseline visit, 18 months
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Overall healthcare costs
Time Frame: 18 months
|
Monthly collection during follow-up (18 months)
|
18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pierre ALLAN, MD, EHPAD MAISON DE RETRAITE SAINT JOSEPH - MAZAMET
- Principal Investigator: Véronique ARNAUD-ULLIET, MD, EHPAD MA MAISON MONTPELLIER
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0910701
- 2009-A01062-55 (Other Identifier: ID-RCB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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