Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Systematic Tracking of Dementia Cases on the Rate of Hospitalization in Emergency Care Units (IDEM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01569997
Recruitment Status : Completed
First Posted : April 4, 2012
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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

Condition or disease Intervention/treatment Phase
Dementia in Nursing Home Other: MultiDisciplinary Team Meetings (MDTM) Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1428 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : May 2010
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Intervention group
Intervention group: nursing homes whose residents benefit from MDTM to identify the cases of dementia and to propose an adequate care project
 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...)
No Intervention: control group
Control group: nursing homes whose residents continue to benefit from usual care


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incidence of hospitalizations in emergency care units [ Time Frame: 18 months ]
    Monthly collection during follow-up (18 months)


Secondary Outcome Measures :
  1. Prevalence of antipsychotic prescription [ Time Frame: Baseline visit, 4 months, 18 months ]
  2. Incidence of inappropriate hospitalizations [ Time Frame: 18 months ]
    Monthly collection during follow-up (18 months)

  3. Prevalence of neuropsychiatric symptoms evaluated by NPI-nursing staff version [ Time Frame: Baseline visit, 18 months ]
  4. Dependency evaluated by AGGIR and IADL-4 items [ Time Frame: Baseline visit, 18 months ]
  5. Quality of life evaluated by QOL-AD [ Time Frame: Baseline visit, 18 months ]
  6. Number of nursing staff's time off work [ Time Frame: 18 months ]
    Monthly collection during follow-up (18 months)

  7. Number of days off work by nursing staff [ Time Frame: 18 months ]
    Monthly collection during follow-up (18 months)

  8. Presence of advanced care planning in patients medical records [ Time Frame: Baseline visit, 18 months ]
    Advanced care planning will be checked through behavioural disosders, transfer to hospital intensive care and resuscitation

  9. Overall healthcare costs [ Time Frame: 18 months ]
    Monthly collection during follow-up (18 months)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569997


Locations
Show Show 90 study locations
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Layout table for investigator information
Principal Investigator: Pierre ALLAN, MD EHPAD MAISON DE RETRAITE SAINT JOSEPH - MAZAMET
Principal Investigator: Véronique ARNAUD-ULLIET, MD EHPAD MA MAISON MONTPELLIER
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01569997    
Other Study ID Numbers: 0910701
2009-A01062-55 ( Other Identifier: ID-RCB )
First Posted: April 4, 2012    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Keywords provided by University Hospital, Toulouse:
Dementia
emergency hospitalization
nursing home
multidisciplinary meeting
cognitive decline
disability
 residents
facilities
long term care unit
health policy
general practitioner
prevention
Additional relevant MeSH terms:
Layout table for MeSH terms
Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders