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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02859805
• Other study ID #: RC12_3341 - 1726
• Status: Completed
• Phase: N/A
• First received: July 28, 2016
• Last updated: August 4, 2016
• Start date: January 2011
• Est. completion date: February 2015

Study information

• Verified date: July 2016
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: February 2015
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	Self questionnaires with Beck Depression Scale	2 years	No
Primary	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	No
Secondary	Socio-demographic data	age, sex, socioeconomic status,	2 years	No
Secondary	clinical evaluation	clinical form of the disease	2 years	No
Secondary	clinical evaluation	current treatments and comorbidities	2 years	No
Secondary	clinical evaluation	Questionnaire administered hetero Q1, Early questionnaire and UPDRS (Unified Parkinson's Disease Rating Scale)	2 years	No