Validation of a Diagnostic Self-assessment Scale Non-moto... | NCT02859805

Studies
Validation of a Diagnostic Self-assessment Scale Non-motor Fluctuations at the Parkinson's Patient

NCT02859805

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Completed

Last Update Posted

Aug 9, 2016Estimated

Enrollment

255Actual

Phase

Not provided

Conditions

Parkinson Disease

Interventions

validation of a diagnostic tool severity of non-motor symptoms in Parkinson patients

Countries

Not provided

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

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jan 2013Actual

Completion Date

Feb 2015Actual

First Submitted Date

Jul 28, 2016

First Submission Date that Met QC Criteria

Aug 4, 2016

First Posted Date

Aug 9, 2016Estimated

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

Aug 4, 2016

Last Update Posted Date

Aug 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

The objective of this study is to validate a diagnostic tool severity of these common non-motor manifestations, disturbing and little recognized as a self-questionnaire. This assessment tool used on different subgroups of patients (free from any treatment at an early stage of the disease and the stage of motor complications) will better understand the natural history of the non-motor fluctuations (FNM)

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

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

255Actual

Name	Type	Description	Arm Group Labels	Other Names
validation of a diagnostic tool severity of non-motor symptoms in Parkinson patients	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of life	Self questionnaires with Beck Depression Scale	2 years
Quality of life	use of measurement scales Quality of Life; PDQ-39 it's a 39-item Parkinson's disease questionnaire (Record socio-demographic information)	2 years

Secondary Outcomes

Measure	Description	Time Frame
Socio-demographic data	age, sex, socioeconomic status,	2 years
clinical evaluation	clinical form of the disease	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient aged 30 or over Patient having an Parkinson's disease Patient hospitalized in one of the clinical sites participating in the project Patient have agreed to participate in the study subject that masters the French language and able to fulfill the self-questionnaire.

Exclusion Criteria:

Patient aged under 30 Patient can not answer the self-administered questionnaire Patient has not agreed to participate in the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patient suffering from Parkinson's disease

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Urielle DESALBRES	Assistance Publique des Hôpitaux de Marseille	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided