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

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)

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: validation of a diagnostic tool severity of non-motor symptoms in Parkinson patients

• Study Type: Observational
• Enrollment (Actual): 255

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patient suffering from Parkinson's disease

Description

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.

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Socio-demographic data	age, sex, socioeconomic status,	2 years
clinical evaluation	clinical form of the disease	2 years
clinical evaluation	current treatments and comorbidities	2 years
clinical evaluation	Questionnaire administered hetero Q1, Early questionnaire and UPDRS (Unified Parkinson's Disease Rating Scale)	2 years

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: August 4, 2016
• First Posted (Estimate): August 9, 2016

Study Record Updates

• Last Update Posted (Estimate): August 9, 2016
• Last Update Submitted That Met QC Criteria: August 4, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: RC12_3341 - 1726