NCT04110106

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
513

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

1.1 years

First QC Date

September 28, 2019

Last Update Submit

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

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

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

Locations