Parkinson DiseasePRIDENCT05556993
Parkinson's Research With Inclusion, Diversity and Equity
An observational study of Parkinson Disease, run by University of Nevada, Las Vegas at 1 site in United States.
Trial summary
The purpose of this study is to identify the health and healthcare needs of LGBTQIA+ and non LGBTQIA+ communities living with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2022to Nov 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population includes individuals aged 18 and older who identify as lesbian, gay, bisexual, transgender, queer, intersex and/or another identity (LGBTQIA+) and non-LGBTQIA+ persons living with Parkinson's disease and their caregivers, as well as health care professional, including physicians, physician assistants, nurse practitioners, psychologists, physical or occupational therapists, registered nurses, social workers, and others, who provide care to persons living with Parkinson's disease.
Who may be able to join
- Identify as LGBTQIA+ or non-LGBTQIA+
- Aged 18+
- Ability to complete the phone or online survey in English/Spanish
- Diagnosis of Parkinson's disease or a caregiver of a person with Parkinson's disease
- Health care professional that provides care to patients living with Parkinson's disease
Who cannot join
- Not having a diagnosis of Parkinson's disease
- Not currently or in the past a caregiver of a person with Parkinson's disease
- Not currently providing care to patients with Parkinson's disease
- Inability to complete the survey in English or Spanish
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Nevada, Las Vegas
Las Vegas, Nevada, 89154
Jason Flatt, PhD, 702-895-5586, jason.flatt@unlv.edu
About this study
The purpose of this study is to identify the health and healthcare needs of LGBTQIA+ and non LGBTQIA+ communities living with Parkinson's disease.
Read the detailed description
Four million LGBTQIA+ adults age 50+ live in the U.S. Very little is known about the needs of the LGBTQIA+ community living with Parkinson's disease (PD). This research will work with the LGBTQIA+ community to learn about the health needs of those living with PD. The researchers will also talk to caregivers about their care experiences, and ask healthcare providers about their work with LGBTQIA+ communities living with PD. LGBTQIA+ adults have more health and care problems. This study will test if LGBTQIA+ adults with PD experience more health and care problems. This study will also see if caregivers have more problems and how providers are caring for the LGBTQIA+ community living with PD. LGBTQIA+ adults living with PD, caregivers and care providers will be asked to fill out a survey. Some caregivers will be asked to participate in an hour interview to learn about their experiences. Surveys and interviews can be done by phone or internet. The study will find ways to improve health and care of LGBTQIA+ people living with PD. The study will share findings so others can help to make care better for the LGBTQIA+ community.
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Caregiver, Health care provider, LGBTQIA+
- 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 |
|---|---|---|
| LGBTQIA+ Persons living with Parkinson's Disease | 125 LGBTQIA+ persons living with Parkinson's Disease will be asked to do a 45-minute phone survey. | |
| Non- LGBTQIA+ Persons living with Parkinson's Disease | 125 Non- LGBTQIA+ persons living with Parkinson's Disease will be asked to do a 45- minute phone survey. | |
| LGBTQIA+ caregivers of people living with Parkinson's Disease | 125 LGBTQIA+ caregivers of people living with Parkinson's Disease will do a 45-minute phone survey. | |
| Non- LGBTQIA+ caregivers of people living with Parkinson's Disease | 125 non- LGBTQIA+ caregivers of people living with Parkinson's Disease will do a 45-minute phone survey. | |
| Health care providers of people living with Parkinson's Disease | 100 health care providers of people living with Parkinson's Disease will complete a 45-minute online survey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptoms
Depressive symptoms will be measured by Patient Health Questionnaire nine items, with higher scores indicating a higher frequency of depressive symptoms
Measured: Baseline
Parkinson's Disease Symptoms
Severity of Parkinson's Disease will be measured by Movement Disorder Society Unified Parkinson's Disease Rating Scale Parts one and two, with higher scores suggesting more severe Parkinson's disease symptoms
Measured: Baseline
Health-related quality of life
Quality of Life is measured by Parkinson's Disease Quality of Life Questionnaire Summary Index eight items, with higher scores indicating worse quality of life
Measured: Baseline
Cognition
Cognition is measured by Telephone Interview for Cognitive Status nine items, with lower scores indicating potential cognitive impairment
Measured: Baseline
Caregiver Burden
Caregiver Burden is measured by Zarit Caregiver Burden Inventory twelve items, with higher scores representing more burden
Measured: Baseline
Cultural Competency of Health Care Providers
Cultural competency is measured by Lesbian, Gay, Bisexual, Transgender Development of Clinical Skills Scale eighteen items, with higher scores indicating higher levels of clinical preparedness and less prejudicial attitudinal awareness regarding LGBT patients
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start29 Jun 2022
- Primary completionApr 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Flatt, PhD, Principal investigator, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556993
- Sponsor's protocol ID
- UNLV-2021-265
- Acronym
- PRIDE
- Status last verified
- Oct 2022
- First submitted
- 22 Sep 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin CR, Rosendale N, Deeb W. Expanding sexual and gender minority research in movement disorders: More than awareness and acceptance. Parkinsonism Relat Disord. 2021 Jun;87:162-165. doi: 10.1016/j.parkreldis.2021.05.019. Epub 2021 May 24.
PubMed 34088617Rosendale N, Wong JO, Flatt JD, Whitaker E. Sexual and Gender Minority Health in Neurology: A Scoping Review. JAMA Neurol. 2021 Jun 1;78(6):747-754. doi: 10.1001/jamaneurol.2020.5536.
PubMed 33616625Anderson JG, Flatt JD. Characteristics of LGBT caregivers of older adults: Results from the national Caregiving in the US 2015 survey. Journal of Gay & Lesbian Social Services. 2018;30(2):103-116.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parkinson's Research With Inclusion, Diversity and Equity
- ClinicalTrials.gov ID
- NCT05556993
- Acronym / sponsor ID
- PRIDE / UNLV-2021-265
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Caregiver, Health care provider, LGBTQIA+
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 27 Sep 2022 (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.
The purpose of this study is to identify the health and healthcare needs of LGBTQIA+ and non LGBTQIA+ communities living with Parkinson's disease.
Detailed description
Four million LGBTQIA+ adults age 50+ live in the U.S. Very little is known about the needs of the LGBTQIA+ community living with Parkinson's disease (PD). This research will work with the LGBTQIA+ community to learn about the health needs of those living with PD. The researchers will also talk to caregivers about their care experiences, and ask healthcare providers about their work with LGBTQIA+ communities living with PD. LGBTQIA+ adults have more health and care problems. This study will test if LGBTQIA+ adults with PD experience more health and care problems. This study will also see if caregivers have more problems and how providers are caring for the LGBTQIA+ community living with PD. LGBTQIA+ adults living with PD, caregivers and care providers will be asked to fill out a survey. Some caregivers will be asked to participate in an hour interview to learn about their experiences. Surveys and interviews can be done by phone or internet. The study will find ways to improve health and care of LGBTQIA+ people living with PD. The study will share findings so others can help to make care better for the LGBTQIA+ community.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| LGBTQIA+ Persons living with Parkinson's Disease | – | –125 LGBTQIA+ persons living with Parkinson's Disease will be asked to do a 45-minute phone survey. |
| Non- LGBTQIA+ Persons living with Parkinson's Disease | – | –125 Non- LGBTQIA+ persons living with Parkinson's Disease will be asked to do a 45- minute phone survey. |
| LGBTQIA+ caregivers of people living with Parkinson's Disease | – | –125 LGBTQIA+ caregivers of people living with Parkinson's Disease will do a 45-minute phone survey. |
| Non- LGBTQIA+ caregivers of people living with Parkinson's Disease | – | –125 non- LGBTQIA+ caregivers of people living with Parkinson's Disease will do a 45-minute phone survey. |
| Health care providers of people living with Parkinson's Disease | – | –100 health care providers of people living with Parkinson's Disease will complete a 45-minute online survey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population includes individuals aged 18 and older who identify as lesbian, gay, bisexual, transgender, queer, intersex and/or another identity (LGBTQIA+) and non-LGBTQIA+ persons living with Parkinson's disease and their caregivers, as well as health care professional, including physicians, physician assistants, nurse practitioners, psychologists, physical or occupational therapists, registered nurses, social workers, and others, who provide care to persons living with Parkinson's disease.
Key inclusion criteria (5 listed)
- Identify as LGBTQIA+ or non-LGBTQIA+
- Aged 18+
- Ability to complete the phone or online survey in English/Spanish
- Diagnosis of Parkinson's disease or a caregiver of a person with Parkinson's disease
- Health care professional that provides care to patients living with Parkinson's disease
Key exclusion criteria (5 listed)
- Not having a diagnosis of Parkinson's disease
- Not currently or in the past a caregiver of a person with Parkinson's disease
- Not currently providing care to patients with Parkinson's disease
- Inability to complete the survey in English or Spanish
- Inability to provide informed consent
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
Depressive Symptoms
Time frame: Baseline
Depressive symptoms will be measured by Patient Health Questionnaire nine items, with higher scores indicating a higher frequency of depressive symptoms
Parkinson's Disease Symptoms
Time frame: Baseline
Severity of Parkinson's Disease will be measured by Movement Disorder Society Unified Parkinson's Disease Rating Scale Parts one and two, with higher scores suggesting more severe Parkinson's disease symptoms
Health-related quality of life
Time frame: Baseline
Quality of Life is measured by Parkinson's Disease Quality of Life Questionnaire Summary Index eight items, with higher scores indicating worse quality of life
Cognition
Time frame: Baseline
Cognition is measured by Telephone Interview for Cognitive Status nine items, with lower scores indicating potential cognitive impairment
Caregiver Burden
Time frame: Baseline
Caregiver Burden is measured by Zarit Caregiver Burden Inventory twelve items, with higher scores representing more burden
Cultural Competency of Health Care Providers
Time frame: Baseline
Cultural competency is measured by Lesbian, Gay, Bisexual, Transgender Development of Clinical Skills Scale eighteen items, with higher scores indicating higher levels of clinical preparedness and less prejudicial attitudinal awareness regarding LGBT patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Background: PubMed 34088617Lin CR, Rosendale N, Deeb W. Expanding sexual and gender minority research in movement disorders: More than awareness and acceptance. Parkinsonism Relat Disord. 2021 Jun;87:162-165. doi: 10.1016/j.parkreldis.2021.05.019. Epub 2021 May 24.
- Background: PubMed 33616625Rosendale N, Wong JO, Flatt JD, Whitaker E. Sexual and Gender Minority Health in Neurology: A Scoping Review. JAMA Neurol. 2021 Jun 1;78(6):747-754. doi: 10.1001/jamaneurol.2020.5536.
- BackgroundAnderson JG, Flatt JD. Characteristics of LGBT caregivers of older adults: Results from the national Caregiving in the US 2015 survey. Journal of Gay & Lesbian Social Services. 2018;30(2):103-116.
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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.
Jason Flatt, PhD principal investigator
University of Nevada, Las Vegas
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 Nevada, Las Vegas 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jason Flatt, PhD (702-895-5586, jason.flatt@unlv.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive Symptoms (time frame: Baseline). The study lists 6 primary outcomes in all. 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 NCT05556993, which also lists 3 linked publications.
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 10 Oct 2022.