MEMORA: Predictive Factors and Autonomy Level Change

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02302482
• Collaborator: (none)
• Enrollment: 10,860
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 156
• Patients Per Site: 5430
• Patients Per Site Per Month: 34.8

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Nov 1, 2014
• Anticipated Primary Completion Date: Nov 1, 2027
• Anticipated Study Completion Date: Nov 1, 2027

Arms and Interventions

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

Primary Outcome Measures

1. Functional autonomy level [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 [3 years]

   Mini Mental Test examination (MMSE)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Dugoujon	Caluire-et-Cuire		France	69300
2	Hospices Civils de Lyon - Hôpital des Charpennes	Lyon		France

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT02302482
• Other Study ID Numbers: 2014.868
• First Posted: Nov 27, 2014
• Last Update Posted: Jun 28, 2021
• Last Verified: Jun 1, 2021

• Keywords provided by Hospices Civils de Lyon: Alzheimer's disease or related disorders; Functional autonomy level; Cognitive function; Predictive factors

Study Results

No Results Posted as of Jun 28, 2021