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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03279445
Other study ID # IRB 17-0998
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 9, 2017
Est. completion date April 10, 2021

Study information

Verified date May 2023
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

More than 10 million people worldwide are living with Parkinson's disease (PD). While the actual number of African American (or Black) patients with PD is unknown, it is clear that there are racial disparities in the access to health care, diagnosis, treatment and survival of PD. The lack of clear knowledge on the possibly lower PD prevalence among African Americans compared to Caucasians further calls for more research in this field. The University of Chicago Medicine is an ideal facility to study this topic, due to its location on the South Side of Chicago with a large African American (or Black) population. By analyzing the demographics, socioeconomics and clinical features of PD patients in our Center for Research Informatics in African American (or Black) patients compared to the Caucasians of similar geographical area, the investigators aim to work toward a better understanding of the unique features of PD in American American (or Black) population, which might help improve the healthcare among this population in the Chicago and possibly nationwide as well.


Description:

The first portion of the study will be a large medical electronic data based search and analysis of patients with PD on demographics, socioeconomic status and clinical features of PD patients. Specifically, we will retrospectively identify PD patients on both races from the electronic medical database spanned from 1/1/2006 to 10/31/2017 and compared demographics, socioeconomic status (educations, incomes and insurances), co-morbidities (all categories, including mood, cognition and psychosis), treatment (medications for parkinsonism and major non-motor symptoms, and frequency and locations of healthcare) and survival, and identified factors associated with medication usage and survival. The second portion was designed to collect more detailed clinical assessments for information not available in the database and blood draws for genetic or candidate gene mutation analysis. Unfortunately, this part of the study could not be carried out due to the COVID-19 pandemic, which began shortly after completion of the first portion of the study. These assessments and analyses would have helped determine if there are significant differences in the clinical and genetic profiles between the African American (or Black) and Caucasian PD patients that account for their differences in clinical features and PD prevalence in these two populations.


Recruitment information / eligibility

Status Completed
Enrollment 2033
Est. completion date April 10, 2021
Est. primary completion date April 10, 2020
Accepts healthy volunteers No
Gender All
Age group 15 Years to 100 Years
Eligibility Inclusion Criteria: - 15 years and older, confirmed diagnosis of PD, African American (or Black) or Caucasian race Exclusion Criteria: Non-PD -

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Chicago Medical Center Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (1)

Xie T, Liao C, Lee D, Yu H, Padmanaban M, Kang W, Johnson J, Alshaikh J, Yuen C, Burns M, Chiu BC. Disparities in diagnosis, treatment and survival between Black and White Parkinson patients. Parkinsonism Relat Disord. 2021 Jun;87:7-12. doi: 10.1016/j.parkreldis.2021.04.013. Epub 2021 Apr 21. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Disparities in diagnosis, treatment and survival between Black and White Parkinson patients We will compare Black/AA and White PD patients on demographics, socioeconomic status (education, income, and insurance), co-morbidities, treatment (medications for parkinsonism and major non-motor symptoms, and frequency and locations of healthcare) and survival, and identify factors associated with medication usage and survival. Through study completion, an average of one year
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