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OpenTrials
Completed

NCT Number: NCT04110106

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

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.

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Key information

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Human Neurosciences, Sapienza University of Rome

Roma, RM, 00185, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

No intervention

Other

All participants were evaluated with the PDQ-39, and the severity of PD was recorded according to the H&Y scale by a neurologist.

Primary outcomes

  1. Hoehn & Yahr (H&Y)

    Time frame: at admission to the neurologic outpatient clinics

    severity of Parkinson's disease

  2. Parkinson's Disease questionnaire (PDQ-39)

    Time frame: at admission to the neurologic outpatient clinics

    quality of life

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 1, 2019
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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