Telehealth Allied Health Care With People Who Have Parkinson's Disease Living in Rural Nevada and Wyoming

December 20, 2017 updated by: University of Wyoming

Decreasing Health Disparities for Parkinson's Disease in Rural Communities: Assessing Feasibility of Coordinated Telehealth to Deliver Allied Health Care of Medication Management, Physical Therapy, and Speech Therapy

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89154
        • Recruiting
        • University of Nevada Las Vegas
        • Contact:
        • Sub-Investigator:
          • Merrill Landers, DPT, PhD
    • Wyoming
      • Laramie, Wyoming, United States, 82070
        • Recruiting
        • University of Wyoming
        • Contact:
        • Principal Investigator:
          • Mary Jo Cooley Hidecker, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Behavioral: Telehealth Exercise, speech therapy, medication management
Telehealth exercise once per week, speech therapy 4 times per week, medication management once per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aim 1: Feasibility of the 8-week telehealth program
Time Frame: 8 weeks
The number of sessions completed and ability to use the necessary technology.
8 weeks
Aim 2: Safety of the 8-week telehealth program
Time Frame: 8 weeks
The frequency and nature of adverse events during participation of the telehealth program.
8 weeks
Aim 3: Change in Signal of efficacy of the telehealth program - overall
Time Frame: 0, 8, 24 weeks
The change in quality of life between baseline at the beginning of the study and after the 8 week intervention. In addition, change will also be measured between the end of the 8 week intervention and 18 weeks later (24 weeks from the baseline). This quality of life measures is a self-report, PD-specific Parkinson's Disease Questionnaire 39 (PDQ39). There are 39 items in 8 subsections (mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, bodily discomfort). Each item ranges from 0 (never) to 4 (always). The overall score and subsection scores are calculated by taking the means of each item divided by the total for that section; thus, converting the score into a percentage with higher percentages equating to more disability.
0, 8, 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aim 3: Signal of efficacy of the telehealth program - pharmacy
Time Frame: 8, 24 weeks
Change in pill count (i.e., how many pills of each prescription are taken) over the period of the study.
8, 24 weeks
Aim 3: Signal of efficacy of the telehealth program - physical therapy 1
Time Frame: 0, 8, 24 weeks
Change in 30 second Sit-to-Stand test which measures how many times the participant can stand in 30 seconds.
0, 8, 24 weeks
Aim 3: Signal of efficacy of the telehealth program - physical therapy 2
Time Frame: 0, 8, 24 weeks
Change in Parkinson's Fatigue Scale, which is a self-report measure of fatigue. This scale measures 16 items using a Likert scale with a low score of 16 (low fatigue) and a high score of 80 (high fatigue).
0, 8, 24 weeks
Aim 3: Signal of efficacy of the telehealth program - physical therapy 3
Time Frame: 0, 8, 24 weeks
Change in Unified Parkinson's Disease Rating Scale II (UPDRS II), which is a self-report of PD-specific motor aspects of experiences of daily living. There are 13 items with scores ranging from 0 (normal) to 4 (severe). Thus, a score of 0 indicates normal function whereas a score of 52 (the highest possible score) suggestive of severe motor deficits with activities of daily living.
0, 8, 24 weeks
Aim 3: Signal of efficacy of the telehealth program - speech therapy 1
Time Frame: 0, 8, 24 weeks
Change in self-report Communication Effectiveness Scale, which is an 8 question scale using a 4-point likert scale on how the participant social participation is affected by his speech and communication. The scores range from 0 (not effective) to 32 (very effective communication in all situations).
0, 8, 24 weeks
Aim 3: Signal of efficacy of the telehealth program - speech therapy 2
Time Frame: 0, 8, 24 weeks
Change in Vocal sound level intensity using the Lee Silverman Voice Treatment (LSVT) Companion Software which measures speech intensity. Changes in vocal sound level could range from - 6 decibel (dB) (reduced loudness) to at least + 6dB which is the average change and is perceptually noticeable.
0, 8, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wyoming

Collaborators

University of Nevada, Las Vegas

Investigators

  • Principal Investigator: Mary Jo Cooley Hidecker, PhD, University of Wyoming
  • Study Director: Merrill Landers, DPT, Ph.D., University of Nevada, Las Vegas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2017

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

May 31, 2019

Study Registration Dates

First Submitted

November 29, 2017

First Submitted That Met QC Criteria

December 20, 2017

First Posted (Actual)

December 22, 2017

Study Record Updates

Last Update Posted (Actual)

December 22, 2017

Last Update Submitted That Met QC Criteria

December 20, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1003674

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a feasibility study to help determine appropriate individual participant data (IPD) categories

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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