Parkinson's DiseaseNCT05532982
Parkinson's Disease in Asian Americans
An observational study of Parkinson's Disease, run by Tufts University at 1 site in United States.
Trial summary
The ultimate goal of this project is to use the findings to develop culturally appropriate programs and resources that can be disseminated to key stakeholders to improve access to PD care and increase inclusivity in PD research for Asian Americans. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Interviews and Surveys
- How many people
- 430 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2022to 30 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: Chinese and Vietnamese patients with Parkinson's disease and their care partners, clinicians, and community advocates.
Who may be able to join
- Objective 1 (chart review):
- Chinese or Vietnamese ethnicity
- Age: 18 years of age or older
- Diagnosed or presented for PD care at the Tufts Medical Center (TMC) Movement Disorders Clinic (MDC) from January 1, 2010 to December 31, 2019.
- Objective 2 (qualitative study):
- Asian American person diagnosed with PD:
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- Diagnosed with PD
- Chinese or Vietnamese ethnicity
- Age: 18 years of age or older
- Able to participate in an interview by phone or on Zoom
- Able to provide informed consent
- Primary caregivers of Asian American PD patients recruited into the study:
- Age: 18 years of age or older
- First-degree family member or spouse
- Self-identified as a primary caregiver of an Asian American person with PD
- Able to participate in an interview by phone or on Zoom
- Able to provide informed consent
- Clinicians:
- Any clinician (e.g. primary care provider, neurologist, resident, nurse, nurse practitioner, etc) that takes care of PD patients.
- Age: 18 years of age or older
- Key advocates in the Asian American community working specifically with the Asian elderly population.
- Employee or volunteer for a community-based organization working with the Asian elderly population (e.g. Greater Boston Chinese Golden Age Center, South Cove Manor, and Midtown Home Health Services) or other organizations working with PD patients and the elderly (e.g. Massachusetts Council on Aging and the Massachusetts Chapter of the American Parkinson's Disease Association)
- Age: 18 years of age or older
- Able to participate in a focus group discussion on Zoom
- Objective 3 (surveys of care partners of Asian American individuals with PD):
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- Chinese or Vietnamese ethnicity
- Primary care partner of a family member with Parkinson's Disease
- Age: 18 years of age or older
- Care partner or family member with Parkinson's Disease must be of Asian descent
Who cannot join
- Objective 1:
- 1. Patients diagnosed with juvenile-onset Parkinson's Disease
- Objective 2:
- PD patients only:
- Patients with juvenile-onset Parkinson's Disease
- Patients diagnosed with dementia
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- Patients on medication for cognitive impairment, e.g., anti-psychotics, donepezil (Aricept), rivastigmine (Exelon), and galantamine (Razadyne)
- No exclusion criteria for other stakeholder groups (caregivers, clinical providers, key community advocates).
- Objective 3:
- 1. Patients with juvenile-onset Parkinson's Disease
Trial locations and contacts
1 site in 1 country.
Naheed Esar contact
United States1 site, 1 recruiting
- Recruiting
Tufts University School of Medicine
Boston, Massachusetts, 02111
Alice Tang, 617-513-9104, alice.tang@tufts.edu
About this study
Official title: Barriers and Motivators Associated With Access to Care and Participation in Research Studies for Parkinson's Disease Among Asian Americans
The ultimate goal of this project is to use the findings to develop culturally appropriate programs and resources that can be disseminated to key stakeholders to improve access to PD care and increase inclusivity in PD research for Asian Americans. This study will serve as a first step towards developing broader community and patient education programs and active outreach campaigns to increase PD-specific literacy among Asian Americans. The results from this study will elucidate the role that language barriers, cultural perceptions, family influence, and other predisposing, enabling, or need factors have on delaying care for PD among Asian Americans. It will also provide much needed insight on how to improve inclusion of Asian Americans in PD research studies.
- Conditions
- Parkinson's Disease
- Being tested
- Interviews and Surveys
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interviews and SurveysOther
Qualitative interviews and surveys
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease patients | Parkinson's disease patients of Asian descent Receives: Other: Interviews and Surveys | |
| Parkinson's disease patients' care-givers | Care partners of Parkinson's Disease patients of Asian descent Receives: Other: Interviews and Surveys | |
| Clinicians | Clinical providers of patients with Parkinson's disease, including physicians, nurses, nurse practitioners, physician assistants, physical therapists, etc. Receives: Other: Interviews and Surveys | |
| Community stakeholders | Advocates for the Asian American community Receives: Other: Interviews and Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay in seeking care
For the main outcome (delay in seeking care), the investigators will rely on self-report. Data obtained from Objectives 1 and 2 will be used to inform the development of a survey question (or a series of questions) that will capture this construct. The questionnaire will be piloted among a subgroup of participants recruited from the TMC MDC to calibrate the self-reported measure against data obtained from their medical records.
Measured: November 2022 - August 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start15 Oct 2022
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Naheed Esar, Asian Women for Health
- Responsible party
- Principal investigator, Alice Tang, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532982
- Sponsor's protocol ID
- MJFF-020935
- Status last verified
- May 2024
- First submitted
- 6 Sep 2022
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barriers and Motivators Associated With Access to Care and Participation in Research Studies for Parkinson's Disease Among Asian Americans
- ClinicalTrials.gov ID
- NCT05532982
- Acronym / sponsor ID
- MJFF-020935
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Naheed Esar, Asian Women for Health
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 8 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 ultimate goal of this project is to use the findings to develop culturally appropriate programs and resources that can be disseminated to key stakeholders to improve access to PD care and increase inclusivity in PD research for Asian Americans. This study will serve as a first step towards developing broader community and patient education programs and active outreach campaigns to increase PD-specific literacy among Asian Americans. The results from this study will elucidate the role that language barriers, cultural perceptions, family influence, and other predisposing, enabling, or need factors have on delaying care for PD among Asian Americans. It will also provide much needed insight on how to improve inclusion of Asian Americans in PD research studies.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease patients | – | Other: Interviews and SurveysParkinson's disease patients of Asian descent |
| Parkinson's disease patients' care-givers | – | Other: Interviews and SurveysCare partners of Parkinson's Disease patients of Asian descent |
| Clinicians | – | Other: Interviews and SurveysClinical providers of patients with Parkinson's disease, including physicians, nurses, nurse practitioners, physician assistants, physical therapists, etc. |
| Community stakeholders | – | Other: Interviews and SurveysAdvocates for the Asian American community |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese and Vietnamese patients with Parkinson's disease and their care partners, clinicians, and community advocates.
Key inclusion criteria (30 listed)
- Objective 1 (chart review):
- Objective 2 (qualitative study):
- <!-- -->
Key exclusion criteria (10 listed)
- 1. Patients diagnosed with juvenile-onset Parkinson's Disease
- Patients with juvenile-onset Parkinson's Disease
- Patients diagnosed with dementia
- Patients on medication for cognitive impairment, e.g., anti-psychotics, donepezil (Aricept), rivastigmine (Exelon), and galantamine (Razadyne)
- No exclusion criteria for other stakeholder groups (caregivers, clinical providers, key community advocates).
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 |
|---|---|---|
| Interviews and SurveysQualitative interviews and surveys | Other | Clinicians, Community stakeholders, Parkinson's disease patients, Parkinson's disease patients' care-givers |
Primary outcome
Delay in seeking care
Time frame: November 2022 - August 2024
For the main outcome (delay in seeking care), the investigators will rely on self-report. Data obtained from Objectives 1 and 2 will be used to inform the development of a survey question (or a series of questions) that will capture this construct. The questionnaire will be piloted among a subgroup of participants recruited from the TMC MDC to calibrate the self-reported measure against data obtained from their medical records.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
Naheed Esar contact
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's Disease, run by Tufts 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 30 inclusion and 10 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 20 May 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?
Contact Alice Tang, PhD (617-636-2140, alice.tang@tufts.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delay in seeking care (time frame: November 2022 - August 2024). 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 20 May 2024.