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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01569997
Other study ID # 0910701
Secondary ID 2009-A01062-55
Status Completed
Phase N/A
First received
Last updated
Start date May 2010
Est. completion date September 2013

Study information

Verified date July 2020
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 1428
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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...)

Locations

Country Name City State
France Centre de Gerontologie Pompeyrie Chu Agen Agen
France Ehpad Maison de Retraite Louise Anceau Albi
France Ehpad Maison de Retraite Olga Ducoudray Albi
France Ehpad Mr "Les Jardins de Jouvence" Albi
France Mapad La Renaudie Ch Albi Albi
France Ehpad Les Ajoncs D'Or Allaire
France Ehpad Maison de Retraite Hl Ax Les Thermes Ax-les-Thermes
France Ehpad Marie Lehman Balma
France Ehpad Kerdigemer Brest
France Ehpad Residence Ker-Heol Brest
France Ehpad Residence Saint Astier Catus
France Mapa de L'Hopital Local de Caussade Caussade
France Ehpad Maison de Retraite Ste Marthe Ceignac
France EHPAD Résidence Castelgirou Cepet
France Ehpad Leon Ronzier Joly Clermont L'herault
France Ehpad Themis Lasplanes Colomiers
France Ehpad Maison de Retraite Joseph Sauvy ERR
France Ehpad Residence Borde Haute Promo-Accueil Escalquens
France Mapad "Firmi" Firmi
France Ehpad Hopital Local Fleurance Fleurance
France Ehpad Mr Bellissen Chi Du Val D'Ariege Foix
France Ehpad Dr Robert Guer
France Ehpad Residence Grand'Maison L'union
France Ehpad Residence Provencale Medicafrance La Roquebrussanne
France Ehpad Residence Clairefontaine Lamorlaye
France Mapad Ch Lavaur Lavaur
France Ehpad Saint Reah Hir Le Conquet
France Ehpad Residence D'Automne de La Ferme Le Mee Sur Seine
France Ehpad Maison de Retraite "Les Charmilles" Lescure d'Albigeois
France Residence Le Parc Lezat Sur Leze
France Ehpad La Cheneraie Lherm
France Ehpad Mr Lagrange Lisle Sur Tarn
France Mapad Labastide Ch Lourdes Lourdes
France Ehpad Emile Dubois Marchiennes
France Ehpad Les Mille Soleils Marciac
France Ehpad Et. Public Gerontologie de Marines Marines
France AP-HM Hôptal La Timone Service de Pédiatrie Mutidisciplinaire Marseille
France Ehpad Maison Retraite Hl Mauvezin Mauvezin
France Ehpad Maison de Retraite Saint Joseph Mazamet
France Ehpad Maison de Retraite Privee de Mazeres Mazeres
France Ehpad L'Ecrin Des Sages Mèze
France Ehpad-Maison Retraite Hl Mirande Mirande
France Ehpad Chis Castelsarrasin-Moissac Moissac
France Ehpad Maison Retraite Ch Montauban Montauban
France Ehpad Era Caso Montauban de Luchon
France Ehpad Ma Maison Montpellier
France Ehpad Maison de Retraite Sainte Agnes Montredon Labessonnie
France Ehpad L'Acacia Nailloux
France Logements Foyer La Fontanelle Naucelle
France Ehpad Fondation Pauliani Nice
France Ehpad Les Noisetiers Nice
France Ehpad Residence Ancilla Nice
France Ehpad Mais de Retraite Saint-Joseph Ossun
France Ehpad Mr Bariol Chi Du Val D'Ariege Pamiers
France Ehpad Residence Le Parc Panazol
France AP-HP Hôpital Necker Enfants Malades Service d'endocrinologie pédiatrique - 149 route de Sèvres Paris
France Ehpad Furtado Heine Paris
France Ehpad Julie Siegfried Paris
France Ehpad La Pirandelle Paris
France Ehpad Residence Anselme Paris
France Ehpad Residence Belleville Paris
France Ehpad Residence Herold Paris
France Ehpad Residence Oceane Paris
France Ehpad Tiers Temps Paris Paris
France Ehpad Residence Adeline Pierre Buffiere
France Ehpad Residence D'Automne Medica-France Reims
France Ehpad L'Oree Du Bois Rieux Volvestre
France Ehpad Residence Saint-Amans Rodez
France Ehpad Le Jardin Des Loges Saint Bonnet
France Ehpad Residence Themis La Joie de Vivre Saint Lys
France Ehpad A Labouilhe Saint Orens de Gameville
France Ehpad Public de Saint-Remy de Provence Saint Remy de Provence
France Ehpad Les Bruyeres Sousceyrac
France Ehpad Maison Retraite Orelia Ch St Gaudens St Gaudens
France Ehpad Genevriers St Martory
France Ehpad Maison de Retraite Chic Tarbes Vic Tarbes
France Ehpad Residence "Le Doyenne Du Carmel" Tarbes
France Ehpad Sainte Anne Tinteniac
France Ehpad de La Cote Pavee Toulouse
France Ehpad Gaubert Toulouse
France Ehpad Mr Henri Iv Toulouse
France Ehpad Pierre Ducis Toulouse
France Ehpad Residence La Cotonniere Toulouse
France Ehpad Residence Le Clos Des Carmes Toulouse
France Ehpad Residence Marguerite Toulouse
France Ehpad Residence Saint-Simon Toulouse
France Usld Domaine de La Cadene Toulouse
France Ehpad Umt Valence-d'albigeois
France Ehpad Maisonneuve Villefranche de Lauragais
France Ehpad Saint-Jacques Villemur Sur Tarn

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

Rolland Y, Tavassoli N, de Souto Barreto P, Perrin A, Laffon de Mazières C, Rapp T, Hermabessière S, Tournay E, Vellas B, Andrieu S. Systematic Dementia Screening by Multidisciplinary Team Meetings in Nursing Homes for Reducing Emergency Department Transf — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of hospitalizations in emergency care units Monthly collection during follow-up (18 months) 18 months
Secondary Prevalence of antipsychotic prescription Baseline visit, 4 months, 18 months
Secondary Incidence of inappropriate hospitalizations Monthly collection during follow-up (18 months) 18 months
Secondary Prevalence of neuropsychiatric symptoms evaluated by NPI-nursing staff version Baseline visit, 18 months
Secondary Dependency evaluated by AGGIR and IADL-4 items Baseline visit, 18 months
Secondary Quality of life evaluated by QOL-AD Baseline visit, 18 months
Secondary Number of nursing staff's time off work Monthly collection during follow-up (18 months) 18 months
Secondary Number of days off work by nursing staff Monthly collection during follow-up (18 months) 18 months
Secondary 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 Baseline visit, 18 months
Secondary Overall healthcare costs Monthly collection during follow-up (18 months) 18 months