Telehealth Allied Health Care With People Who Have Parkinson's Disease Living in Rural Nevada and Wyoming
NCT ID: NCT03381898
Last Updated: 2017-12-22
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
20 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-11-02
Study Completion Date
2019-05-31
Brief Summary
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The investigators have developed a three-part allied health care intervention to be delivered via telehealth. These interventions are usually provided face-to-face. Telehealth access to healthcare is needed for people with Parkinson's disease living in rural locations, where providers are sparse and long travel times are often not feasible because of weather conditions, as well as the hallmark symptom of Parkinson's disease, movement disorders
Detailed Description
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Parkinson's Disease \& Allied Health. Parkinson's disease (PD), the second most common neurodegenerative disorder affecting more than a million people in the U.S., has no known cause or cure. Persons with PD use prescription medications and behavioral interventions to alleviate key problems such as walking, handling objects, and speaking. Individuals with PD, accessing multidisciplinary allied health care intervention, have shown functional gains. Without these ongoing, coordinated services, persons with PD become even more debilitated, and this can hasten a decline in their quality of life.
Parkinson's Disease \& Rurality. For those in rural areas, there is a critical health disparity. People who live rurally contend with isolation. Wyoming and Nevada's population density are ranked 49th and 42nd. In conjunction with this low population density and mountainous terrain, individuals experience tremendous burdens including traveling long distances to see health care providers with expertise in treating PD. These factors contribute to the struggle of rural Americans with PD to manage this complicated, chronic disease.
Parkinson's Disease \& Telehealth. Telehealth technology has successfully allowed the delivery of neurology care via "virtual house calls" with rural residents with PD. The virtual house call model was determined to be feasible and promising for specialist care in underserved rural areas. However, telehealth delivery of allied health care should also be examined.
Thus, the investigators propose an exploratory Phase 2 Behavioral Clinical Trial to determine feasibility, safety, and signal of efficacy for telehealth coordinated allied health care for persons with Parkinson's disease in rural Wyoming and Nevada. All 20 participants will be in one arm receiving telehealth exercise, speech therapy, and medication management for eight weeks.
Specific Aims:
For persons with Parkinson's disease in rural Wyoming and Nevada, the investigators will:
Aim 1 Test the feasibility of speech therapy, exercise therapy and medication management coordinated through telehealth.
Aim 2 Determine the safety of the coordinated telehealth speech therapy, exercise therapy, and medication management.
Aim 3 Measure signal of efficacy for telehealth outcomes
Parkinson's Disease \& Rurality. For those in rural areas, there is a critical health disparity. People who live rurally contend with isolation. Wyoming and Nevada's population density are ranked 49th and 42nd. In conjunction with this low population density and mountainous terrain, individuals experience tremendous burdens including traveling long distances to see health care providers with expertise in treating PD. These factors contribute to the struggle of rural Americans with PD to manage this complicated, chronic disease.
Parkinson's Disease \& Telehealth. Telehealth technology has successfully allowed the delivery of neurology care via "virtual house calls" with rural residents with PD. The virtual house call model was determined to be feasible and promising for specialist care in underserved rural areas. However, telehealth delivery of allied health care should also be examined.
Thus, the investigators propose an exploratory Phase 2 Behavioral Clinical Trial to determine feasibility, safety, and signal of efficacy for telehealth coordinated allied health care for persons with Parkinson's disease in rural Wyoming and Nevada. All 20 participants will be in one arm receiving telehealth exercise, speech therapy, and medication management for eight weeks.
Specific Aims:
For persons with Parkinson's disease in rural Wyoming and Nevada, the investigators will:
Aim 1 Test the feasibility of speech therapy, exercise therapy and medication management coordinated through telehealth.
Aim 2 Determine the safety of the coordinated telehealth speech therapy, exercise therapy, and medication management.
Aim 3 Measure signal of efficacy for telehealth outcomes
Conditions
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Parkinson Disease
Keywords
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Telehealth
Physical therapy exercise
Speech therapy Lee Silverman voice treatment
Pharmacy medication management
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
This is a feasibility and safety trial of a single arm a telehealth intervention (pharmacy, physical therapy, and speech therapy) to people with Parkinson's disease.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
The outcomes assessment and the care providers will be blind to the aims of the study.
Study Groups
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Telehealth Coordinated Allied Health
rural persons with Parkinson's disease will receive telehealth exercise, speech therapy, medication management for 8 weeks. Exercise, speech therapy, and medication management are usual care for persons with Parkinson's disease. Having the 3 areas coordinated in delivery via telehealth is the new delivery that our aims address
Group Type
EXPERIMENTAL
Telehealth Exercise, speech therapy, medication management
Intervention Type
BEHAVIORAL
Telehealth exercise once per week, speech therapy 4 times per week, medication management once per week
Interventions
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Telehealth Exercise, speech therapy, medication management
Telehealth exercise once per week, speech therapy 4 times per week, medication management once per week
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* Speak English
* Are 30 years or older
* Have been diagnosed with Parkinson's Disease by a primary care provider
* Allow for us to communicate about you to your primary care provider (i.e., physician, nurse practitioner, or physician assistant)
* Can stand alone for 10 min without holding on to anything
* Are taking at least one medication for Parkinson's Disease
* Are willing the participate in an 8-week study
* Will provide your physical address, your phone number, and an emergency contact's phone number for us to use if an emergency occurs during your telehealth session.
* Are 30 years or older
* Have been diagnosed with Parkinson's Disease by a primary care provider
* Allow for us to communicate about you to your primary care provider (i.e., physician, nurse practitioner, or physician assistant)
* Can stand alone for 10 min without holding on to anything
* Are taking at least one medication for Parkinson's Disease
* Are willing the participate in an 8-week study
* Will provide your physical address, your phone number, and an emergency contact's phone number for us to use if an emergency occurs during your telehealth session.
Exclusion Criteria
* Have dementia or problems following directions
* Have a medical diagnosis that would limit exercises
* have experienced a fall that required physician evaluation (Emergency Department, urgent care or a hospitalization) within the past year
* Requires an assistive device or person (e.g., cane or walker) for walking, standing, balancing
* Currently use a structured exercise regimen defined as participation in a regular exercise program consisting of more than 60 minutes per week in total
* Have a medical diagnosis that would limit exercises
* have experienced a fall that required physician evaluation (Emergency Department, urgent care or a hospitalization) within the past year
* Requires an assistive device or person (e.g., cane or walker) for walking, standing, balancing
* Currently use a structured exercise regimen defined as participation in a regular exercise program consisting of more than 60 minutes per week in total
Minimum Eligible Age
30 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Nevada, Las Vegas
OTHER
Sponsor Role
collaborator
University of Wyoming
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Mary Jo Cooley Hidecker, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wyoming
Merrill Landers, DPT, Ph.D.
Role: STUDY_DIRECTOR
University of Nevada, Las Vegas
Locations
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University of Nevada Las Vegas
Las Vegas, Nevada, United States
Site Status
RECRUITING
University of Wyoming
Laramie, Wyoming, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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Kathleen Nagle, LPN
Role: primary
Kathleen Nagle, LPN
Role: primary
References
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Other Identifiers
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1003674
Identifier Type: -
Identifier Source: org_study_id