Parkinson DiseaseLGBTQ+_PDNCT05502055
Perspectives on Healthcare Access and Equity of People With Parkinson's Disease Identifying as LGBTQ+
An observational study of Parkinson Disease and Sexual Orientation, run by Creighton University at 1 site in United States.
Trial summary
Study Rationale: Older adults who identify as lesbian, gay, bisexual, transgender, or queer (LGBTQ+) have worse health than non-LGBTQ+ older adults. They and their care partners face greater barriers to getting healthcare and support from friends and family. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Sexual Orientation
- What is being tested?
- Individual interviews, Focus Groups and National Survey
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2022to Oct 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals from across the United States, from urban and rural areas and across diverse socioeconomic environments, with online access for a 2-hour period on a single day.
Who may be able to join
- Diagnosed with PD
- Care partner of someone diagnosed with PD
- Health Care Provider providing services to individuals with PD
- Identify as LGBTQ+
- Identify as Non-LGBTQ+
Who cannot join
- Non-English speaking
- Inability to communicate via video conferencing
Trial locations and contacts
1 site in 1 country.
United States1 site
Creighton University Phoenix
Phoenix, Arizona, 85012
About this study
Official title: Perspectives on Healthcare Access and Equity of People With Parkinson's Disease Identifying as Lesbian, Gay, Bisexual, Transgender, Questioning, Intersex, or Two-spirit
Study Rationale:
Older adults who identify as lesbian, gay, bisexual, transgender, or queer (LGBTQ+) have worse health than non-LGBTQ+ older adults. They and their care partners face greater barriers to getting healthcare and support from friends and family. This is because of lifelong stigma, discrimination, and isolation often separated from their families. Parkinson disease (PD) is a disease that usually appears in older age, so there may be many LGBTQ+ elders with PD, but there is currently no information on how people with PD who are LGBTQ+ are coping with their disease and aging. This study will begin to clarify their needs.
Read more
Hypothesis/Research Question:
What are the experiences and perspectives of LGBTQ+ people living with PD, their care partners, and physicians managing people with PD?
Study Design:
The investigators will interview 20 people with PD, half who identify as LGBTQ+ and half who are not. The investigators will also interview their care partners and physicians who treat people with PD. From the responses to the interview questions, investigators will create a survey that will be sent to people across the country.
Impact on Diagnosis/Treatment of Parkinson's Disease:
By understanding what LGBTQ+ people with PD need, and what ideas they have for improving their healthcare, better systems for meeting their needs can be built.
Next Steps for Development:
With this understanding, future work can focus on educating healthcare providers and clinics to improve the ways they talk with and treat LGBTQ+ people with PD.
Read the detailed description
This mixed-methods study has a qualitative study component (1) and a quantitative study component (2):
Component 1) using a phenomenological inductive approach and Grounded Theory methodology the investigators will find and build themes from semi-structured interviews and focus groups with a) LGBTQ+ and non-LGBTQ+ individuals with PD, b) their care partners, and c) physicians to identify the experiences and perspectives on their health care and participation in research.
Component 2) survey development informed by results of Component 1, national distribution, and analysis of LGBTQ+ and non-LGBTQ+ people with PD, their caregivers and physicians, on barriers and access to health and disease information, healthcare delivery and participation in research.
The investigators plan to recruit 10 LGBTQ+ individuals with PD, 10 Non-LGBTQ+ individuals with PD, 10 care partners, and 10 healthcare providers for individual interviews, and 50 LGBTQ+ older adults with PD and care partners for focus groups consisting of 6-8 individuals each. For the national electronic survey investigators estimate needing a the sample size of approximately 380 responses calculated using a 95% confidence level (Z score=1.96), a standard deviation of .5, a 5% margin of error, and a population of 30,000. Purposive and Snowball sampling methods (nonprobability sampling) will be used.
- Conditions
- Parkinson Disease, Sexual Orientation
- Being tested
- Individual interviews, Focus Groups, National Survey
- Medical subject headings
- Parkinson Disease, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual interviewsOther
One on One interviews by Zoom video conferencing, < 2 hours in duration
Focus GroupsOther
Focus Groups discussions by Zoom video conferencing, < 2 hours in duration
National SurveyOther
Survey conducted online and distributed nationally
| Study group | Role | What they receive |
|---|---|---|
| LGBTQ+_PD | Individuals who identify as LGBTQ+ and are diagnosed with PD Receives: Other: Individual interviews; Other: Focus Groups; Other: National Survey | |
| Non-LGBTQ_PD | Individuals who identify as non-LGBTQ+ and are diagnosed with PD Receives: Other: Individual interviews; Other: Focus Groups; Other: National Survey | |
| Care Partner | Individuals who are Care Partners of individuals with PD Receives: Other: Individual interviews; Other: Focus Groups; Other: National Survey | |
| Health Care Provider | Health Care Providers who provide service to people with PD Receives: Other: Individual interviews; Other: Focus Groups; Other: National Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Themes of Lived Experience Accessing Health Care Services
Inductive and iterative thematic analysis of transcripts
Measured: 2 hours
Themes of Lived Experience Providing Health Care Services to LGBTQ+ people with PD
Inductive and iterative thematic analysis of transcripts
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start18 Oct 2022
- Primary completionMay 2025 (estimated)
- Study completionOct 2025 (estimated)
Why it stopped: Medical event of PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tara McIsaac, Creighton University
- Investigators
- Tara L McIsaac, PT, PhD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502055
- Sponsor's protocol ID
- 2003114-01
- Acronym
- LGBTQ+_PD
- Status last verified
- Nov 2024
- First submitted
- 12 Aug 2022
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perspectives on Healthcare Access and Equity of People With Parkinson's Disease Identifying as Lesbian, Gay, Bisexual, Transgender, Questioning, Intersex, or Two-spirit
- ClinicalTrials.gov ID
- NCT05502055
- Acronym / sponsor ID
- LGBTQ+_PD / 2003114-01
- Conditions
- Parkinson Disease, Sexual Orientation
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Medical event of PI
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 16 Aug 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.
Study Rationale:
Older adults who identify as lesbian, gay, bisexual, transgender, or queer (LGBTQ+) have worse health than non-LGBTQ+ older adults. They and their care partners face greater barriers to getting healthcare and support from friends and family. This is because of lifelong stigma, discrimination, and isolation often separated from their families. Parkinson disease (PD) is a disease that usually appears in older age, so there may be many LGBTQ+ elders with PD, but there is currently no information on how people with PD who are LGBTQ+ are coping with their disease and aging. This study will begin to clarify their needs.
Hypothesis/Research Question:
What are the experiences and perspectives of LGBTQ+ people living with PD, their care partners, and physicians managing people with PD?
Study Design:
The investigators will interview 20 people with PD, half who identify as LGBTQ+ and half who are not. The investigators will also interview their care partners and physicians who treat people with PD. From the responses to the interview questions, investigators will create a survey that will be sent to people across the country.
Impact on Diagnosis/Treatment of Parkinson's Disease:
By understanding what LGBTQ+ people with PD need, and what ideas they have for improving their healthcare, better systems for meeting their needs can be built.
Next Steps for Development:
With this understanding, future work can focus on educating healthcare providers and clinics to improve the ways they talk with and treat LGBTQ+ people with PD.
Detailed description
This mixed-methods study has a qualitative study component (1) and a quantitative study component (2):
Component 1) using a phenomenological inductive approach and Grounded Theory methodology the investigators will find and build themes from semi-structured interviews and focus groups with a) LGBTQ+ and non-LGBTQ+ individuals with PD, b) their care partners, and c) physicians to identify the experiences and perspectives on their health care and participation in research.
Component 2) survey development informed by results of Component 1, national distribution, and analysis of LGBTQ+ and non-LGBTQ+ people with PD, their caregivers and physicians, on barriers and access to health and disease information, healthcare delivery and participation in research.
The investigators plan to recruit 10 LGBTQ+ individuals with PD, 10 Non-LGBTQ+ individuals with PD, 10 care partners, and 10 healthcare providers for individual interviews, and 50 LGBTQ+ older adults with PD and care partners for focus groups consisting of 6-8 individuals each. For the national electronic survey investigators estimate needing a the sample size of approximately 380 responses calculated using a 95% confidence level (Z score=1.96), a standard deviation of .5, a 5% margin of error, and a population of 30,000. Purposive and Snowball sampling methods (nonprobability sampling) will be used.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LGBTQ+_PD | – | Other: Individual interviews, Other: Focus Groups, Other: National SurveyIndividuals who identify as LGBTQ+ and are diagnosed with PD |
| Non-LGBTQ_PD | – | Other: Individual interviews, Other: Focus Groups, Other: National SurveyIndividuals who identify as non-LGBTQ+ and are diagnosed with PD |
| Care Partner | – | Other: Individual interviews, Other: Focus Groups, Other: National SurveyIndividuals who are Care Partners of individuals with PD |
| Health Care Provider | – | Other: Individual interviews, Other: Focus Groups, Other: National SurveyHealth Care Providers who provide service to people with PD |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals from across the United States, from urban and rural areas and across diverse socioeconomic environments, with online access for a 2-hour period on a single day.
Key inclusion criteria (5 listed)
- Diagnosed with PD
- Care partner of someone diagnosed with PD
- Health Care Provider providing services to individuals with PD
- Identify as LGBTQ+
- Identify as Non-LGBTQ+
Key exclusion criteria (2 listed)
- Non-English speaking
- Inability to communicate via video conferencing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual interviewsOne on One interviews by Zoom video conferencing, < 2 hours in duration | Other | Care Partner, Health Care Provider, LGBTQ+_PD, Non-LGBTQ_PD |
| Focus GroupsFocus Groups discussions by Zoom video conferencing, < 2 hours in duration | Other | Care Partner, Health Care Provider, LGBTQ+_PD, Non-LGBTQ_PD |
| National SurveySurvey conducted online and distributed nationally | Other | Care Partner, Health Care Provider, LGBTQ+_PD, Non-LGBTQ_PD |
Primary outcome
Themes of Lived Experience Accessing Health Care Services
Time frame: 2 hours
Inductive and iterative thematic analysis of transcripts
Themes of Lived Experience Providing Health Care Services to LGBTQ+ people with PD
Time frame: 2 hours
Inductive and iterative thematic analysis of transcripts
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- 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.
Tara L McIsaac, PT, PhD principal investigator
Creighton University
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 and Sexual Orientation, run by Creighton University 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 2 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: paused, as of the sponsor's last update on 6 Nov 2024. 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?
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?
Themes of Lived Experience Accessing Health Care Services (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2024.