Parkinson DiseaseNCT05725772
Comparison of Health Care Delivery Methods in Parkinson's Disease
An observational study of Parkinson Disease, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Location of Visit
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2022to 30 Dec 2023
- 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 45 to 90 years
- All sexes
- Adult, Older adult
Study population: People with Parkinson's disease living in designated medically underserved areas.
Who may be able to join
- Age range of 45- to 90-years old
- Diagnosis of idiopathic PD as defined by the UK Brain Bank criteria.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Comparison of Different Health Care Delivery Methods in a Rural Underserved Population of People With Parkinson's Disease
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.
Read the detailed description
The purpose of the current project is to determine whether care for people with Parkinson's disease can be performed as well using telemedicine as it can be when people visit their neurologist in-person. We hope that the findings from this project will help 1) improve the quality and access of healthcare to those parts of Arkansas where access may be limited, 2) decrease the costs of healthcare in movement disorders, and 3) allow more people with Parkinson's disease to feel like they are participating in finding a cure by taking part in research. It will also allow us to improve on ways to collect information from people with Parkinson's, even in their own homes, to help us design future research studies. This will be important to help develop treatments that are for each person, not just the disease as a whole.
Specific Aims of the Study:
AIM 1: To determine whether telehealth assessments provide high quality care to people with Parkinson's disease. We will do this by performing and comparing the results of assessments that are regularly used in clinics and in research repeated in 3 different settings, at-home via telehealth, at a regional center via telehealth, and in-person at UAMS.
AIM 2: To improve tools for studying large collections of information that are collected using multiple different methods. We will do this by using a health information database that we have developed for this purpose. We will use voice and handwriting analysis compared in the three different settings to develop ways to track disease progression in Parkinson's disease.
How we plan to accomplish those Aims:
All people with Parkinson's who agree to participate will have their regular clinical visits with Dr. Tuhin Virmani or Dr. Rohit Dhall at home and at a UAMS regional clinic center near their homes. Following the clinic portion of the visit they will provide a sample of their speech and handwriting, undergo a timed walk, have their thinking ability tested, and fill out some questionnaires and surveys about their mood, anxiety, quality of life, and sleep quality. They will also be asked to complete surveys to allow us to determine who they feel the quality of each visit type was and at the end compare one to the other. These different sources of information from each person will then be combined together and stored in our database, and used by the research team to develop new tools to combine and compare such different types of information to better treat people with Parkinson's Disease in the future.
- Conditions
- Parkinson Disease
- Being tested
- Location of Visit
- Keywords
- medically underserved areas, telemedicine, remote monitoring
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Location of VisitOther
Participants will perform visits 1) at-home via telemedicine, 2) in-person and 3) at a local regional clinic via telemedicine
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease | People with Parkinson's disease living in medically underserved areas Receives: Other: Location of Visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of remote data collection
Feasibility of remotely collecting high-quality research data on a smartphone, tablet, or home computer.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start13 Dec 2022
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
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.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tuhin Virmani, MD, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725772
- Sponsor's protocol ID
- 274510
- Status last verified
- Jan 2024
- First submitted
- 3 Feb 2023
- Last updated
- 8 Jan 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 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Health Care Delivery Methods in a Rural Underserved Population of People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05725772
- Acronym / sponsor ID
- 274510
- Conditions
- Parkinson Disease
- Keywords
- medically underserved areas, telemedicine, remote monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 13 Feb 2023 (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 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.
Detailed description
The purpose of the current project is to determine whether care for people with Parkinson's disease can be performed as well using telemedicine as it can be when people visit their neurologist in-person. We hope that the findings from this project will help 1) improve the quality and access of healthcare to those parts of Arkansas where access may be limited, 2) decrease the costs of healthcare in movement disorders, and 3) allow more people with Parkinson's disease to feel like they are participating in finding a cure by taking part in research. It will also allow us to improve on ways to collect information from people with Parkinson's, even in their own homes, to help us design future research studies. This will be important to help develop treatments that are for each person, not just the disease as a whole.
Specific Aims of the Study:
AIM 1: To determine whether telehealth assessments provide high quality care to people with Parkinson's disease. We will do this by performing and comparing the results of assessments that are regularly used in clinics and in research repeated in 3 different settings, at-home via telehealth, at a regional center via telehealth, and in-person at UAMS.
AIM 2: To improve tools for studying large collections of information that are collected using multiple different methods. We will do this by using a health information database that we have developed for this purpose. We will use voice and handwriting analysis compared in the three different settings to develop ways to track disease progression in Parkinson's disease.
How we plan to accomplish those Aims:
All people with Parkinson's who agree to participate will have their regular clinical visits with Dr. Tuhin Virmani or Dr. Rohit Dhall at home and at a UAMS regional clinic center near their homes. Following the clinic portion of the visit they will provide a sample of their speech and handwriting, undergo a timed walk, have their thinking ability tested, and fill out some questionnaires and surveys about their mood, anxiety, quality of life, and sleep quality. They will also be asked to complete surveys to allow us to determine who they feel the quality of each visit type was and at the end compare one to the other. These different sources of information from each person will then be combined together and stored in our database, and used by the research team to develop new tools to combine and compare such different types of information to better treat people with Parkinson's Disease in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease | – | Other: Location of VisitPeople with Parkinson's disease living in medically underserved areas |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- People with Parkinson's disease living in designated medically underserved areas.
Key inclusion criteria (2 listed)
- Age range of 45- to 90-years old
- Diagnosis of idiopathic PD as defined by the UK Brain Bank criteria.
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Location of VisitParticipants will perform visits 1) at-home via telemedicine, 2) in-person and 3) at a local regional clinic via telemedicine | Other | Parkinson's disease |
Primary outcome
Feasibility of remote data collection
Time frame: 12 weeks
Feasibility of remotely collecting high-quality research data on a smartphone, tablet, or home computer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 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.
Tuhin Virmani, MD, PhD principal investigator
University of Arkansas
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 Arkansas 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 8 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of remote data collection (time frame: 12 weeks). 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 8 Jan 2024.