Predictive Factors and Autonomy Level Change (MEMORA)

June 25, 2021 updated by: Hospices Civils de Lyon

Predictive Factors of the Autonomy Level Change Related to Memory Disorders

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10860

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Caluire-et-Cuire, France, 69300
        • Not yet recruiting
        • Hôpital Dugoujon
        • Contact:
          • Sylvain GAUJARD
        • Principal Investigator:
          • Sylvain Gaujard
      • Lyon, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive function level
Time Frame: 3 years
Mini Mental Test examination (MMSE)
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Anticipated)

November 1, 2027

Study Completion (Anticipated)

November 1, 2027

Study Registration Dates

First Submitted

November 14, 2014

First Submitted That Met QC Criteria

November 24, 2014

First Posted (Estimate)

November 27, 2014

Study Record Updates

Last Update Posted (Actual)

June 28, 2021

Last Update Submitted That Met QC Criteria

June 25, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014.868

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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