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Clinical Trials/NCT04110106
NCT04110106CompletedNot Applicable

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

R.O.M.A. - Rehabilitation & Outcome Measures Assessment1 site in 1 country513 target enrollmentStarted: February 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
513
Locations
1
Primary Endpoint
Parkinson's Disease questionnaire (PDQ-39)

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
50 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

Parkinson's Disease questionnaire (PDQ-39)

Time Frame: at admission to the neurologic outpatient clinics

quality of life

Hoehn & Yahr (H&Y)

Time Frame: at admission to the neurologic outpatient clinics

severity of Parkinson's disease

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
R.O.M.A. - Rehabilitation & Outcome Measures Assessment
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Giovanni Galeoto

Department of Public Health and Infection disease, Sapienza University of Rome

R.O.M.A. - Rehabilitation & Outcome Measures Assessment

Study Sites (1)

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