Determinants of Quality of Life Related to Health in Alzh... | NCT01570322

Studies
Determinants of Quality of Life Related to Health in Alzheimer Disease

NCT01570322

Sponsor

CHU de Reims

Status

Unknown status

Last Update Posted

Jun 9, 2016Estimated

Enrollment

400Estimated

Phase

Not provided

Conditions

Alzheimer Disease

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 2, 2012

First Submission Date that Met QC Criteria

Apr 2, 2012

First Posted Date

Apr 4, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2016

Last Update Posted Date

Jun 9, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Study the factors that explain Health-Related Quality of Life (HRQL) in patients with Alzheimer disease including:

The influence of the environment (physical and human) on Health-Related Quality of Life (HRQL),
The influence of non-drug and drug treatments on Health-Related Quality of Life (HRQL),
The influence of formal and informal help mobilized,
The influence of interactions "patient - caregiver" on Health-Related Quality of Life (HRQL),
The influence of the ratio necessary cost on available resources on Health-Related Quality of Life (HRQL)

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Measure	Description	Time Frame
Health-Related Quality of Life (HRQOL) Assessment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with Alzheimer disease (DSM IV and NINCDS-ADRDA)
Patients with MMSE (Mini Mental State Examination) > or = 10
Out patients

Exclusion Criteria:

Severe sensory disturbances,
Non French speaking

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Patients with Alzheimer disease (DSM IV - Diagnostic and Statistical Manual of Mental Disorders - and NINCDS/ADRDA - National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association)
Patients with MMSE (Mini Mental State Examination) > or = 10

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jean-Luc NOVELLA, MD PhD	Contact			jlnovella@chu-reims.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de REIMS	Recruiting	Reims	France	51092	France

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided