| Primary | Feasibility of Virtual Visits for Parkinson Disease | Feasibility of virtual visits will be determined by the number of participants who complete at least one virtual visit successfully. | | Posted | | Number | | participants | | One year | | | | ID | Title | Description |
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| OG000 | Usual Care and Educational Materials | Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state. | | OG001 | Virtual Visits and Educational Materials | 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. Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone). |
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| Primary | Change From Baseline in the Quality of Life Measured by Parkinson Disease Questionnaire 39 | 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. | Data was not collected on 17 participants in the usual care arm and 18 participants in the virtual visits arm. | Posted | | Mean | Standard Error | units on a scale | | Baseline to One year | | | | ID | Title | Description |
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| OG000 | Usual Care and Educational Materials | Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state. | | OG001 | Virtual Visits and Educational Materials | 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. Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone). |
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| Secondary | Change in EQ-5D Index Value | 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). | Data was not collected in 6 participants from the usual care arm and 9 participants from the virtual visits arm. | Posted | | Mean | Standard Error | units on a scale | | baseline to one year | | | | ID | Title | Description |
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| OG000 | Usual Care and Educational Materials | Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state. | | OG001 | Virtual Visits and Educational Materials | 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. Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone). |
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| Secondary | Change in Montreal Cognition Assessment | 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. | Data was not collected on 6 participants in the usual care arm and 9 participants in the virtual visits arm. | Posted | | Mean | Standard Error | units on a scale | | baseline to one year | | | | ID | Title | Description |
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| OG000 | Usual Care and Educational Materials | Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state. | | OG001 | Virtual Visits and Educational Materials | 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. Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone). |
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| Secondary | Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IA | 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. | Data was not collected in 6 participants from the usual care arm and 8 participants from the virtual visits arm. | Posted | | Mean | Standard Error | units on a scale | | baseline to one year | | | | ID | Title | Description |
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| OG000 | Usual Care and Educational Materials | Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state. | | OG001 | Virtual Visits and Educational Materials | 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. Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone). |
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| Secondary | Change in Patient Assessment of Chronic Illness Care | 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. | Data was not collected in 16 participants from the usual care arm and 12 participants from the virtual visits arm. | Posted | | Mean | Standard Error | units on a scale | | baseline to one year | | | | ID | Title | Description |
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| OG000 | Usual Care and Educational Materials | Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state. | | OG001 | Virtual Visits and Educational Materials | 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. Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone). |
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| Secondary | Minutes Spend on Last Parkinson's Disease Provider Visit | | Data was not collected on 10 participants in the usual care arm and 28 participants in the virtual visits arm. | Posted | | Median | Inter-Quartile Range | minutes | | One year | | | | ID | Title | Description |
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| OG000 | Usual Care and Educational Materials | Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state. | | OG001 | Virtual Visits and Educational Materials | 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. Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone). |
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| Secondary | Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IB | 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. | Data was not collected in 11 participants from the usual care arm and 7 participants from the virtual visits arm. | Posted | | Mean | Standard Error | units on a scale | | baseline to one year | | | | ID | Title | Description |
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| OG000 | Usual Care and Educational Materials | Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state. | | OG001 | Virtual Visits and Educational Materials | 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. Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone). |
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| Secondary | Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 2 | 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. | Data was not collected in 12 participants from the usual care arm and 7 participants from the virtual visits arm. | Posted | | Mean | Standard Error | units on a scale | | baseline to one year | | | | ID | Title | Description |
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| OG000 | Usual Care and Educational Materials | Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state. | | OG001 | Virtual Visits and Educational Materials | 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. Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone). |
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| Secondary | Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 3 | 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. | Data was not collected in 9 participants from the usual care arm and 9 participants from the virtual visits arm. | Posted | | Mean | Standard Error | units on a scale | | baseline to one year | | | | ID | Title | Description |
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| OG000 | Usual Care and Educational Materials | Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state. | | OG001 | Virtual Visits and Educational Materials | 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. Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone). |
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| Secondary | Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 4 | 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. | Data was not collected in 6 participants from the usual care arm and 9 participants from the virtual visits arm. | Posted | | Mean | Standard Error | units on a scale | | baseline to one year | | | | ID | Title | Description |
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| OG000 | Usual Care and Educational Materials | Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state. | | OG001 | Virtual Visits and Educational Materials | 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. Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone). |
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