Parkinson DiseaseNCT03279445
Parkinson's Disease in African American and Caucasian Patients
An observational study of Parkinson Disease, run by University of Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 15 to 100 years
- Conditions the study is for
- Parkinson Disease
- How many people
- 2,033 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2017to 10 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Parkinson's patients of either African American (or Black) or Caucasian race.
Who may be able to join
- 15 years and older, confirmed diagnosis of PD, African American (or Black) or Caucasian race
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: Characteristics of African American People With Parkinson's Disease: A Hospital Based Study at the University of Chicago of the African American Community in Chicago's South Side
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.
Read the detailed 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.
- Conditions
- Parkinson Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| African American | Patient of African American race | |
| Caucasian | Patient of Caucasian race |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start9 Aug 2017
- Primary completion10 Apr 2020
- Study completion10 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,033 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Xie, MD, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279445
- Sponsor's protocol ID
- IRB 17-0998
- Status last verified
- May 2023
- First submitted
- 14 Aug 2017
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33905958
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of African American People With Parkinson's Disease: A Hospital Based Study at the University of Chicago of the African American Community in Chicago's South Side
- ClinicalTrials.gov ID
- NCT03279445
- Acronym / sponsor ID
- IRB 17-0998
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,033 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 9 Aug 2017 (actual)
- Primary completion
- 10 Apr 2020 (actual)
- Study completion
- 10 Apr 2021 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| African American | – | –Patient of African American race |
| Caucasian | – | –Patient of Caucasian race |
Who may qualify
- Ages
- 15 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Parkinson's patients of either African American (or Black) or Caucasian race.
Key inclusion criteria (1 listed)
- 15 years and older, confirmed diagnosis of PD, African American (or Black) or Caucasian race
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disparities in diagnosis, treatment and survival between Black and White Parkinson patients
Time frame: Through study completion, an average of one year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
- Background: PubMed 33905958Xie 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tao Xie, MD, PhD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disparities in diagnosis, treatment and survival between Black and White Parkinson patients (time frame: Through study completion, an average of one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03279445, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2023.