Pilot Randomized Controlled Trial of Telemedicine for Individuals With Parkinson Disease in a Rural Population

Study Overview
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Brief Summary
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To eliminate barriers (such as travel and cost) to specialized Parkinson disease (PD) care, two movement disorder specialists at the University of Rochester will be providing telemedicine visits for patients with PD who reside in the Presbyterian Home for Central New York in New Hartford, NY, or for individuals who participate in the local support group that meets at the nursing home. Participants will attend 3 telemedicine visits at the Presbyterian Home over the course of 6 months. We hypothesize that this telemedicine model will in time improve access to care and hence the quality of life and quality of care of individuals with PD.

Detailed Description
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Study participants are recruited from the Presbyterian Home and from the Central New York Parkinson Support Group. Anyone interested will attend a screening and baseline visit at the Presbyterian Home, where they will receive baseline surveys and a motor assessment. Eligible participants will be randomized to receive either telemedicine or standard of care. Each telemedicine visit (Month 1, Month 3, Month 6) will take place in a 1:1 fashion between the study participant and the physician investigator - one of two movement disorder specialists from the University of Rochester - via televideo linkage, and will last approximately 30-60 minutes. The study participant will be observed by the physician investigator and she/he will be accompanied by a Presbyterian Home staff member to ensure safety throughout the telemedicine visit. The visit will be structured much the same as a standard clinical visit and will include: Study participant's update on his or her clinical condition Review of current medications, which will be provided in advance of the visit Review and update of medical and social histories Vital signs, including weight (provided by the Presbyterian Home staff) Pertinent neurological exam, including a modified motor examination led by physician investigator Assessment of current clinical state Dictated recommendations including a letter to the attending physician for ongoing clinical care, including changes to the PD medications Participants assigned to the control group will receive their care as routinely scheduled with their own primary care physician and/or neurologist. Staff members from the University of Rochester will return to the Presbyterian Home within one month of the six month study to complete final assessments with all study participants. These will include: Reportable events form Health care events form Quality of life and healthcare evaluation surveys Continuation of care survey 1:1 interviews Telemedicine focus groups

Official Title
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Pilot Randomized Controlled Trial of Telemedicine for Individuals With Parkinson Disease in a Rural Population

Conditions
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Parkinson Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to provide informed consent Age 30 years old or older Clinical diagnosis of idiopathic Parkinson's disease as determined by having two of the four cardinal features of PD (rest tremor, bradykinesia, cogwheel rigidity, and gait instability) and no better alternative explanation for the etiology of the symptoms Able to converse in English Willing and able to complete study requirements Exclusion Criteria: Any neurological, medical, or psychiatric condition that would preclude the patient having the ability to provide informed consent or to participate in the telemedicine visit.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Telemedicine care | |
| 2<br>Standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The feasibility of telemedicine, based on participant ability to complete 75% or more of the trial visits. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parkinson's Disease Questionnaire-39 (PDQ-39) |  | 6 months | 
| EuroQol (EQ-5D) |  | 6 months | 
| Geriatric Depression Scale Short Form (GDS-15) |  | 6 months | 
| Modified Group Health Association of America's Consumer Satisfaction Survey (GHAA) |  | 6 months | 
| Qualitative assessment, including a telemedicine focus group and 1:1 interviews with study participants |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson disease, Telemedicine