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

August 4, 2016 updated by: Assistance Publique Hopitaux De Marseille

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

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

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

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

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

Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life Time Frame: 2 years	Self questionnaires with Beck Depression Scale	2 years
Quality of life Time Frame: 2 years	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 Time Frame: 2 years	age, sex, socioeconomic status,	2 years
clinical evaluation Time Frame: 2 years	clinical form of the disease	2 years
clinical evaluation Time Frame: 2 years	current treatments and comorbidities	2 years
clinical evaluation Time Frame: 2 years	Questionnaire administered hetero Q1, Early questionnaire and UPDRS (Unified Parkinson's Disease Rating Scale)	2 years

Collaborators and Investigators

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

Sponsor

Assistance Publique Hopitaux De Marseille

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

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)