NCT05725772

Brief Summary

The goal of this observational study is to compare the ability to perform telemedicine visits at home, at a regional clinic close to home, and in-person in People with Parkinson's disease. The main question it aims to answer is whether telemedicine assessments provide high quality care to people with Parkinson's disease. Participants will perform a regular clinic visit followed by research evaluations of their disease. Researchers will compare the results of these assessments at the different visit types to see if there are differences in the results.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

January 8, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

February 3, 2023

Last Update Submit

January 5, 2024

Conditions

Keywords

medically underserved areastelemedicineremote monitoring

Outcome Measures

Primary Outcomes (1)

  • Feasibility of remote data collection

    Feasibility of remotely collecting high-quality research data on a smartphone, tablet, or home computer.

    12 weeks

Study Arms (1)

Parkinson's disease

People with Parkinson's disease living in medically underserved areas

Other: Location of Visit

Interventions

Participants will perform visits 1) at-home via telemedicine, 2) in-person and 3) at a local regional clinic via telemedicine

Parkinson's disease

Eligibility Criteria

Age45 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

People with Parkinson's disease living in designated medically underserved areas.

You may qualify if:

  • Age range of 45- to 90-years old
  • Diagnosis of idiopathic PD as defined by the UK Brain Bank criteria.

You may not qualify if:

  • Cognitive impairments sufficient to preclude capacity to provide informed consent, as determined by Dr. Virmani or Dr. Dhall on the basis of each potential participant's stated understanding of the study following review of the consent form;
  • Diagnosis of neurological disorder other than PD
  • Diagnosis of a psychiatric disorder (other than depression or anxiety from PD)
  • Use of anti-dopaminergic medications in 1-year period prior to enrollment
  • Inability to complete questionnaires or effectively communicate in English
  • Inability to perform research assessments via smartphone, tablet or computer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Tuhin Virmani, MD, PhD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2023

First Posted

February 13, 2023

Study Start

December 13, 2022

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

January 8, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations