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
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Aim 3: Change in Signal of efficacy of the telehealth program - overall
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The outcomes assessment and the care providers will be blind to the aims of the study.
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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
干预措施: Telehealth Exercise, speech therapy, medication management (Behavioral)
结局指标
主要结局
Aim 3: Change in Signal of efficacy of the telehealth program - overall
时间窗: 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.
Aim 1: Feasibility of the 8-week telehealth program
时间窗: 8 weeks
The number of sessions completed and ability to use the necessary technology.
Aim 2: Safety of the 8-week telehealth program
时间窗: 8 weeks
The frequency and nature of adverse events during participation of the telehealth program.
次要结局
- 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 - pharmacy(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 - speech therapy 1(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 2(0, 8, 24 weeks)