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

NCT03381898 | Unknown

• 1 other identifier: 1003674
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Conditions

Parkinson Disease

Keywords

Telehealth; Physical therapy exercise; Speech therapy Lee Silverman voice treatment; Pharmacy medication management

Outcome Measures

Primary Outcomes (3)

• Aim 1: Feasibility of the 8-week telehealth program

  The number of sessions completed and ability to use the necessary technology.

  8 weeks

• Aim 2: Safety of the 8-week telehealth program

  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

  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 Outcomes (6)

• Aim 3: Signal of efficacy of the telehealth program - pharmacy

  8, 24 weeks

• Aim 3: Signal of efficacy of the telehealth program - physical therapy 1

  0, 8, 24 weeks

• Aim 3: Signal of efficacy of the telehealth program - physical therapy 2

  0, 8, 24 weeks

• Aim 3: Signal of efficacy of the telehealth program - physical therapy 3

  0, 8, 24 weeks

• Aim 3: Signal of efficacy of the telehealth program - speech therapy 1

  0, 8, 24 weeks

Study Arms (1)

Telehealth Coordinated Allied Health

EXPERIMENTAL

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

Interventions

Telehealth Exercise, speech therapy, medication management BEHAVIORAL

Telehealth exercise once per week, speech therapy 4 times per week, medication management once per week

Telehealth Coordinated Allied Health

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wyoming: lead
• University of Nevada, Las Vegas: collaborator

Study Sites (2)

University of Nevada Las Vegas

Las Vegas, Nevada, 89154, United States

RECRUITING

University of Wyoming

Laramie, Wyoming, 82070, United States

RECRUITING

Related Publications (41)

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MeSH Terms

Conditions

Parkinson Disease

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Mary Jo Cooley Hidecker, PhD

  University of Wyoming

  PRINCIPAL INVESTIGATOR

• Merrill Landers, DPT, Ph.D.

  University of Nevada, Las Vegas

  STUDY DIRECTOR

Central Study Contacts

Kathleen Nagle, LPN

CONTACT

7028951377; kathleen.nagle@unlv.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The outcomes assessment and the care providers will be blind to the aims of the study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 22, 2017
• Study Start: November 2, 2017
• Primary Completion: December 31, 2018
• Study Completion: May 31, 2019
• Last Updated: December 22, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)