Connect.Parkinson: Connecting Individuals With Parkinson Disease to Specialists in Their Homes
- Conditions
- Parkinson Disease
- Interventions
- Other: Virtual Visits
- Registration Number
- NCT02038959
- Lead Sponsor
- University of Rochester
- Brief Summary
Connect.Parkinson is a randomized comparative effectiveness study, comparing usual care enhanced with educational materials to usual care, educational materials, and the delivery of specialty care via telemedicine into patient's homes. The study's specific aims are the following:
1. To demonstrate the feasibility of using telemedicine to deliver specialty care into the homes of individuals with Parkinson disease who have limited access to care;
2. To show that such an approach can improve quality of life;
3. To establish that the telemedicine can enhance the quality of care; and
4. To demonstrate that this remote approach to care saves time, reduces travel, and decreases care partner burden.
- Detailed Description
Connect.Parkinson is a national study examining the feasibility and effectiveness of using video calls to bring expert Parkinson disease care directly into patients' homes. Currently, access to care for Parkinson disease is limited by distance, disability, and the distribution of doctors. Approximately 200 individuals with Parkinson disease (who due to distance, disability, disparity, or doctor distribution have limited access to care) will be randomized to one of two arms in this comparative effectiveness study. The first (control) arm will be the individual's "usual care" supplemented by educational materials on their condition. This usual care may include care from a generalist, care from a neurologist, or in-person care from a Parkinson specialist. The care received by the control group will vary but will be an accurate reflection of usual care in this country. The second (intervention) arm will be usual care supplemented by educational materials and care from a Parkinson disease specialist delivered via web-based video conferencing into the patient's home. The participants will also be asked with they have a primary care partner, and care partners will be invited to enroll, for a total of approximately 400 participants.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
- Individuals with clinically diagnosed Idiopathic Parkinson disease in the judgment of the independent rater
- No better alternative explanation for the parkinsonism
- Access to a non-public, internet-enabled device (e.g., computer, tablet computer, smart phone) that has the capacity for web-based video conferencing
- Be physically located at time visits are conducted in a state where the participating physician is licensed to practice medicine
- Have a local care provider that the study team can contact
- Live at home, in a senior housing complex, or assisted living facility
- Be fluent in English (all participating states) or Spanish (participants in Florida and Massachusetts only)
- Willing and able to provide informed consent
- Care partner (if applicable) must be able and willing to provide informed consent to participate if he or she so chooses.
- Currently hospitalized
- Condition (e.g., prominent psychosis) that precludes study participation as identified by the medical professional (site investigator or nurse).
- Participation in another telemedicine study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Virtual Visits and Educational Materials Virtual Visits Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.
- Primary Outcome Measures
Name Time Method Feasibility of Virtual Visits for Parkinson Disease One year Feasibility of virtual visits will be determined by the number of participants who complete at least one virtual visit successfully.
Change From Baseline in the Quality of Life Measured by Parkinson Disease Questionnaire 39 Baseline to One year Assessed as the change in quality of life, measured by the Parkinson Disease Questionnaire 39 (PDQ-39). The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month. Assesses how often patients experience difficulties across the 8 quality of life dimensions. Assesses impact of Parkinson's Disease (PD) on specific dimensions of functioning and well-being. The score ranges from 0-100 with lower scores reflecting better quality of life.
- Secondary Outcome Measures
Name Time Method Change in EQ-5D Index Value baseline to one year EuroQol five dimensions questionnaire (EQ-5D) is a standardized instrument for measuring generic health status. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale ranges from 11111 to 55555 with higher numbers indicating worse health status. The five-digit descriptors are converted to EQ-5D Index Values, which range from -0.109 (corresponding to 55555, the worst possible health) to 1.000 (corresponding to 11111, the best possible health).
Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IA baseline to one year Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part I concerns nonmotor experiences of daily living. The scale ranges from 0 to 24 with higher numbers indicated more severe disease.
Change in Patient Assessment of Chronic Illness Care baseline to one year We will assess change in the perceived quality of care using the Patient Assessment of Chronic Illness Care (PACIC). Each scale is scored by averaging the items completed within that scale, and the overall PACIC is scored by averaging scores across all 20 items. The scale ranges from 1-5 with higher scores indicating better care by the health team.
Change in Montreal Cognition Assessment baseline to one year We will assess changes in cognition from baseline to the end of the study using the Montreal Cognitive Assessment (MoCA), administered remotely. The scale ranges from 0-30 with higher numbers indicating better cognition.
Minutes Spend on Last Parkinson's Disease Provider Visit One year Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IB baseline to one year Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part I concerns nonmotor experiences of daily living. The scale ranges from 0 to 52 with higher numbers indicated more severe disease.
Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 2 baseline to one year Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part II concerns motor experiences of daily living. The scale ranges from 0 to 52 with higher numbers indicated more severe disease.
Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 3 baseline to one year Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part III is retained as the motor examination. The scale ranges from 0 to 108 with higher numbers indicated more severe disease.
Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 4 baseline to one year Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part IV concerns motor complications. The scale ranges from 0 to 24 with higher numbers indicated more severe disease.
Trial Locations
- Locations (20)
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
The Parkinson's Institute and Clinical Center
🇺🇸Sunnyvale, California, United States
University of Miami
🇺🇸Miami, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Georgia Regents University
🇺🇸Augusta, Georgia, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Struthers Parkinson Center
🇺🇸Golden Valley, Minnesota, United States
Northshore Long Island Jewish - Feinstein Institute
🇺🇸Manhasset, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Northwest Neurological, PLLC
🇺🇸Spokane, Washington, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
The Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Florida
🇺🇸Gainsville, Florida, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States