Correlation Between Quality of Life and Severity of Parkinson's Disease
1 other identifier
observational
513
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 25, 2019
CompletedFirst Submitted
Initial submission to the registry
September 28, 2019
CompletedFirst Posted
Study publicly available on registry
October 1, 2019
CompletedOctober 1, 2019
September 1, 2019
1.1 years
September 28, 2019
September 28, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Hoehn & Yahr (H&Y)
severity of Parkinson's disease
at admission to the neurologic outpatient clinics
Parkinson's Disease questionnaire (PDQ-39)
quality of life
at admission to the neurologic outpatient clinics
Interventions
All participants were evaluated with the PDQ-39, and the severity of PD was recorded according to the H\&Y scale by a neurologist.
Eligibility Criteria
Fivehundred thirteen individuals with Parkinson's Disease (PD) were recruited, all of whom agreed to participate and were thus included in the study. From the general analysis resulted that the greatest number of participants were stage II, according to Hoehn \& Yahr (H\&Y), followed by stage III, stage I, and finally stage IV. Participants between the age of 50 and 69 were mainly stage I or II, while participants aged 70 to 89 had a greater severity of PD (stage II and III). Most women were in H\&Y stage II and III, while most men were mainly in stage II, followed by stage I and III, with a very similar number of participants. A common result for all analyses was the presence of a very low number of participants with stage IV.
You may qualify if:
- 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.
You may not qualify if:
- Individuals with emotional or psychiatric problems (as determined by clinical screening)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Human Neurosciences, Sapienza University of Rome
Roma, RM, 00185, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Public Health and Infection disease, Sapienza University of Rome
Study Record Dates
First Submitted
September 28, 2019
First Posted
October 1, 2019
Study Start
February 1, 2018
Primary Completion
March 25, 2019
Study Completion
September 25, 2019
Last Updated
October 1, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will share