Correlation Between Quality of Life and Severity of Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Correlation Between Quality of Life and Severity of Parkinson's Disease by Assessing an Optimal Cut-off Point on the Parkinson's Disease Questionnaire (PDQ-39) as Related to the Hoehn & Yahr (H&Y) Scale

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04110106
• Other study ID #: Quality of Life and Parkinson
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: September 25, 2019

Study information

• Verified date: September 2019
• Source: R.O.M.A. - Rehabilitation & Outcome Measures Assessment
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aim to evaluate the correlation between Quality of Life (QoL) and severity of Parkinson's Disease (PD) by assessing the presence of an optimal cut-off point on the Parkinson's disease questionnaire (PDQ-39) as related to the Hoehn & Yahr (H&Y) scale in a cohort of Italian adults with PD.

A multicenter, cross-sectional study was performed in central and northern Italy. This study was conducted on a cohort of consecutive individuals at three neurologic outpatient clinics. All participants were evaluated with the PDQ-39, and the severity of PD was recorded according to the H&Y scale by a neurologist. Receiver operating characteristic (ROC) curves and coordinates of the curve, which were visually inspected, were used to find cut-off points with optimal sensitivity and specificity. These were in turn used to determine the optimal PDQ-39 cut-off score for identifying disease severity according to H&Y stages.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 513
• Est. completion date: September 25, 2019
• Est. primary completion date: March 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

• age > 50 but < 90 years,

• H&Y stages I, II, III, and IV,

• a mini-mental state examination > 22 points,

• a minimum level of five years of education.

Exclusion Criteria:

• Individuals with emotional or psychiatric problems (as determined by clinical screening)

Related Conditions & MeSH terms

• Parkinson Disease
• Quality of Life

Intervention

Other:
• no intervention
All participants were evaluated with the PDQ-39, and the severity of PD was recorded according to the H&Y scale by a neurologist.

Locations

Country	Name	City	State
Italy	Department of Human Neurosciences, Sapienza University of Rome	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
R.O.M.A. - Rehabilitation & Outcome Measures Assessment

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hoehn & Yahr (H&Y)	severity of Parkinson's disease	at admission to the neurologic outpatient clinics
Primary	Parkinson's Disease questionnaire (PDQ-39)	quality of life	at admission to the neurologic outpatient clinics