NCT05532982

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
430

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

October 15, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

May 20, 2024

Status Verified

May 1, 2024

Enrollment Period

2.1 years

First QC Date

September 6, 2022

Last Update Submit

May 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    November 2022 - August 2024

Study Arms (4)

Parkinson's disease patients

Parkinson's disease patients of Asian descent

Other: Interviews and Surveys

Parkinson's disease patients' care-givers

Care partners of Parkinson's Disease patients of Asian descent

Other: Interviews and Surveys

Clinicians

Clinical providers of patients with Parkinson's disease, including physicians, nurses, nurse practitioners, physician assistants, physical therapists, etc.

Other: Interviews and Surveys

Community stakeholders

Advocates for the Asian American community

Other: Interviews and Surveys

Interventions

Qualitative interviews and surveys

CliniciansCommunity stakeholdersParkinson's disease patientsParkinson's disease patients' care-givers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chinese and Vietnamese patients with Parkinson's disease and their care partners, clinicians, and community advocates.

You may qualify if:

  • 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:
  • 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
  • +15 more criteria

You may not qualify if:

  • Objective 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
  • Patients on medication for cognitive impairment, e.g., anti-psychotics, donepezil (Aricept), rivastigmine (Exelon), and galantamine (Razadyne)
  • Objective 3:
  • \. Patients with juvenile-onset Parkinson's Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts University School of Medicine

Boston, Massachusetts, 02111, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Interviews as TopicSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 6, 2022

First Posted

September 8, 2022

Study Start

October 15, 2022

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

May 20, 2024

Record last verified: 2024-05

Locations