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Predictive Factors and Autonomy Level Change (MEMORA)

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ClinicalTrials.gov Identifier: NCT02302482
Recruitment Status : Recruiting
First Posted : November 27, 2014
Last Update Posted : June 28, 2021
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief Summary:
The Alzheimer's disease or related disorders (ADRD) are among the most disabling diseases because of their main features such as cognitive impairment, loss of functional autonomy and behavioural disorders. In absence of current curative treatment, the identification of the predictive risk factors of progression of the disease, evaluated through its main symptoms, represents a major stake of public health. The investigators aimed at developing a database, which includes the patient medical records on a prospective basis, in collaboration with the medical and administrative personal and with the University hospital computer science department. The main objective is to study the predictive factors associated with the change of functional autonomy level, measured every 6 months to 12 months by phone, in a Memory Clinic. The study population would consist in about 1000 patients with ADRD. The length of follow-up of each patient will be 3 years.

Condition or disease Intervention/treatment Phase
Memory Impairment Other: The Lawton Instrumental Activities of Daily Living score (IADL), and the disability assessment of dementia score (DAD-6 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10860 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Predictive Factors of the Autonomy Level Change Related to Memory Disorders
Actual Study Start Date : November 2014
Estimated Primary Completion Date : November 2027
Estimated Study Completion Date : November 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arms and Interventions
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Arm Intervention/treatment
Experimental: Functional autonomy level collection
Collection of the Functional autonomy level every 6 - 12 months by phone
 Other: The Lawton Instrumental Activities of Daily Living score (IADL), and the disability assessment of dementia score (DAD-6


Outcome Measures
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Primary Outcome Measures :
  1. Functional autonomy level [ Time Frame: 3 years ]
    The scores of "Lawton Instrumental Activities of Daily Living" (IADL) and of "Disability Assessment of Dementia" (DAD-6)


Secondary Outcome Measures :
  1. Cognitive function level [ Time Frame: 3 years ]
    Mini Mental Test examination (MMSE)


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who undergo a medical visit in the Memory Clinic for the 1st time
  • Patients living at home or in housing
  • Patients with memory impairment, at all stage of the disease

Exclusion Criteria:

  • Patients in institution
  • Patients under legal protection
  • Patients with a hearing or visual impairment, which dot not allow to carry out the examination
Contacts and Locations
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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): NCT02302482


Contacts
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Contact: Pierre Krolak-Salmon, Professor (0)4 72 43 20 50 ext +33 pierre.krolak-salmon@chu-lyon.fr
Contact: Virginie Dauphinot, Doctor (0)4 72 43 20 50 ext +33 virginie.dauphinot@chu-lyon.fr

Locations
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France
Hôpital Dugoujon Not yet recruiting
Caluire-et-Cuire, France, 69300
Contact: Sylvain Gaujard         
Principal Investigator: Sylvain Gaujard         
Hospices Civils de Lyon - Hôpital des Charpennes Recruiting
Lyon, France
Contact: Pierre KROLAK-SALMON, Pr    (0)4 72 43 20 50 ext +33    pierre.krolak-salmon@chu-lyon.fr   
Contact: Virginie DAUPHINOT    (0)4 72 43 20 50 ext +33    virginie.dauphinot@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02302482    
Other Study ID Numbers: 2014.868
First Posted: November 27, 2014    Key Record Dates
Last Update Posted: June 28, 2021
Last Verified: June 2021
Keywords provided by Hospices Civils de Lyon:
Alzheimer's disease or related disorders
Functional autonomy level
Cognitive function
Predictive factors