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

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ClinicalTrials.gov Identifier: NCT03381898
Recruitment Status : Recruiting
First Posted : December 22, 2017
Last Update Posted : December 22, 2017
Sponsor:
Collaborator:
University of Nevada, Las Vegas
Information provided by (Responsible Party):
University of Wyoming

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Parkinson Disease Behavioral: Telehealth Exercise, speech therapy, medication management Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Masking Description: The outcomes assessment and the care providers will be blind to the aims of the study.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 2, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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).

  6. 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.



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03381898


Contacts
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Contact: Kathleen Nagle, LPN 7028951377 kathleen.nagle@unlv.edu

Locations
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United States, Nevada
University of Nevada Las Vegas Recruiting
Las Vegas, Nevada, United States, 89154
Contact: Kathleen Nagle, LPN    702-895-1377    kathleen.nagle@unlv.edu   
Sub-Investigator: Merrill Landers, DPT, PhD         
United States, Wyoming
University of Wyoming Recruiting
Laramie, Wyoming, United States, 82070
Contact: Kathleen Nagle, LPN    702-895-1055    kathleen.nagle@unlv.edu   
Principal Investigator: Mary Jo Cooley Hidecker, PhD         
Sponsors and Collaborators
University of Wyoming
University of Nevada, Las Vegas
Investigators
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Principal Investigator: Mary Jo Cooley Hidecker, PhD University of Wyoming
Study Director: Merrill Landers, DPT, Ph.D. University of Nevada, Las Vegas

Publications:
Mather, M., Jacobsen, L.A., & Pollard, K.M. (2015). Aging in the United Sates. Population Bulletin 70
Fox, C.M., & Ramig, L.O. (1997). Vocal sound pressure level and self-perception of speech and voice in men and women with idiopathic parkinson disease. Am J Speech Lang Pathol 6, 85-94
Stempak, N. (2016). Physical therapy for Parkinson's: The balancing act of fall prevention involves cueing, exercise, and plenty of patience. Long-Term Living: For the Continuing Care Professional 65, 12.
Cipolle, R.J., Strand, L., and Morley, P.C. (2012). Pharmaceutical care practice: The patient-centered approach to medication management.(New York: McGraw-Hill)
Hustad, K.C. (1999). Optimizing communicative effectiveness: Bringing it together. In Management of motor speech disorders in children and adults, K. Yorkston, D. Beukelman, E.A. Strand, andK.R. Bell, eds. (Austin, TX, Pro-Ed), pp 483-537
Donovan, N.J., Velozo, C.A., Rosenbek, J.C. (2007). The communicative effectiveness survey: Investigating its item-level psychometrics. Journal of Medical Speech-Language Pathology 15, 433-447

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Responsible Party: University of Wyoming
ClinicalTrials.gov Identifier: NCT03381898     History of Changes
Other Study ID Numbers: 1003674
First Posted: December 22, 2017    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is a feasibility study to help determine appropriate individual participant data (IPD) categories

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wyoming:
Telehealth
Physical therapy exercise
Speech therapy Lee Silverman voice treatment
Pharmacy medication management
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases