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Connect.Parkinson: Connecting Individuals With Parkinson Disease to Specialists in Their Homes

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ClinicalTrials.gov Identifier: NCT02038959
Recruitment Status : Completed
First Posted : January 17, 2014
Results First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
National Parkinson Foundation
Information provided by (Responsible Party):
Ray Dorsey, University of Rochester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Health Services Research
Condition Parkinson Disease
Intervention Other: Virtual Visits
Enrollment 210
Recruitment Details Individuals with Parkinson disease were recruited and enrolled remotely and sent educational materials about Parkinson disease created by the National Parkinson Foundation. Recruitment for the study began in February 2014.
Pre-assignment Details 272 individuals were referred to 18 sites to be consented. Two hundred ten individuals with Parkinson disease enrolled in the study, and 195 were eventually randomized.
Arm/Group Title Usual Care and Educational Materials Virtual Visits and Educational Materials
Hide Arm/Group Description 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.

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).

Period Title: Overall Study
Started 98 97
Completed 92 89
Not Completed 6 8
Reason Not Completed
Withdrawal by Subject             6             8
Arm/Group Title Usual Care and Educational Materials Virtual Visits and Educational Materials Total
Hide Arm/Group Description 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.

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).

Total of all reporting groups
Overall Number of Baseline Participants 98 97 195
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 98 participants 97 participants 195 participants
66.9  (8.5) 65.9  (7.8) 66.4  (8.1)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 97 participants 195 participants
Female
42
  42.9%
49
  50.5%
91
  46.7%
Male
56
  57.1%
48
  49.5%
104
  53.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 98 participants 97 participants 195 participants
98
 100.0%
97
 100.0%
195
 100.0%
Minutes spent with Parkinson disease provider   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Minutes
Number Analyzed 98 participants 97 participants 195 participants
30
(20 to 45)
30
(20 to 45)
30
(20 to 45)
[1]
Measure Description: Time spent with the provider at the participants last appointment was collected in minutes. At baseline this would be the time the participant spent with their provider at their last appointment prior to enrolling in the study.
1.Primary Outcome
Title Feasibility of Virtual Visits for Parkinson Disease
Hide Description Feasibility of virtual visits will be determined by the number of participants who complete at least one virtual visit successfully.
Time Frame One year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care and Educational Materials Virtual Visits and Educational Materials
Hide Arm/Group Description:
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.

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).

Overall Number of Participants Analyzed 98 97
Measure Type: Number
Unit of Measure: participants
0 95
2.Primary Outcome
Title Change From Baseline in the Quality of Life Measured by Parkinson Disease Questionnaire 39
Hide Description 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.
Time Frame Baseline to One year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was not collected on 17 participants in the usual care arm and 18 participants in the virtual visits arm.
Arm/Group Title Usual Care and Educational Materials Virtual Visits and Educational Materials
Hide Arm/Group Description:
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.

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).

Overall Number of Participants Analyzed 81 79
Mean (Standard Error)
Unit of Measure: units on a scale
-0.7512  (0.9472) -0.4123  (1.0029)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care and Educational Materials, Virtual Visits and Educational Materials
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Change in EQ-5D Index Value
Hide Description 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).
Time Frame baseline to one year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was not collected in 6 participants from the usual care arm and 9 participants from the virtual visits arm.
Arm/Group Title Usual Care and Educational Materials Virtual Visits and Educational Materials
Hide Arm/Group Description:
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.

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).

Overall Number of Participants Analyzed 92 88
Mean (Standard Error)
Unit of Measure: units on a scale
-0.04122  (0.01074) -0.02728  (0.01139)
4.Secondary Outcome
Title Change in Montreal Cognition Assessment
Hide Description 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.
Time Frame baseline to one year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was not collected on 6 participants in the usual care arm and 9 participants in the virtual visits arm.
Arm/Group Title Usual Care and Educational Materials Virtual Visits and Educational Materials
Hide Arm/Group Description:
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.

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).

Overall Number of Participants Analyzed 92 88
Mean (Standard Error)
Unit of Measure: units on a scale
0.2072  (0.243) 0.6485  (0.2566)
5.Secondary Outcome
Title Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IA
Hide Description 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.
Time Frame baseline to one year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was not collected in 6 participants from the usual care arm and 8 participants from the virtual visits arm.
Arm/Group Title Usual Care and Educational Materials Virtual Visits and Educational Materials
Hide Arm/Group Description:
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.

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).

Overall Number of Participants Analyzed 92 89
Mean (Standard Error)
Unit of Measure: units on a scale
-1.0122  (0.2979) -0.8546  (0.3117)
6.Secondary Outcome
Title Change in Patient Assessment of Chronic Illness Care
Hide Description 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.
Time Frame baseline to one year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was not collected in 16 participants from the usual care arm and 12 participants from the virtual visits arm.
Arm/Group Title Usual Care and Educational Materials Virtual Visits and Educational Materials
Hide Arm/Group Description:
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.

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).

Overall Number of Participants Analyzed 82 85
Mean (Standard Error)
Unit of Measure: units on a scale
0.2456  (0.1001) 0.2795  (0.1035)
7.Secondary Outcome
Title Minutes Spend on Last Parkinson's Disease Provider Visit
Hide Description [Not Specified]
Time Frame One year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was not collected on 10 participants in the usual care arm and 28 participants in the virtual visits arm.
Arm/Group Title Usual Care and Educational Materials Virtual Visits and Educational Materials
Hide Arm/Group Description:
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.

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).

Overall Number of Participants Analyzed 88 69
Median (Inter-Quartile Range)
Unit of Measure: minutes
30
(20 to 45)
30
(20 to 40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care and Educational Materials, Virtual Visits and Educational Materials
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
8.Secondary Outcome
Title Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IB
Hide Description 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.
Time Frame baseline to one year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was not collected in 11 participants from the usual care arm and 7 participants from the virtual visits arm.
Arm/Group Title Usual Care and Educational Materials Virtual Visits and Educational Materials
Hide Arm/Group Description:
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.

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).

Overall Number of Participants Analyzed 87 90
Mean (Standard Error)
Unit of Measure: units on a scale
0.389  (0.3701) 0.1243  (0.3786)
9.Secondary Outcome
Title Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 2
Hide Description 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.
Time Frame baseline to one year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was not collected in 12 participants from the usual care arm and 7 participants from the virtual visits arm.
Arm/Group Title Usual Care and Educational Materials Virtual Visits and Educational Materials
Hide Arm/Group Description:
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.

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).

Overall Number of Participants Analyzed 86 90
Mean (Standard Error)
Unit of Measure: units on a scale
-0.3266  (0.5084) 0.1378  (0.512)
10.Secondary Outcome
Title Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 3
Hide Description 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.
Time Frame baseline to one year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was not collected in 9 participants from the usual care arm and 9 participants from the virtual visits arm.
Arm/Group Title Usual Care and Educational Materials Virtual Visits and Educational Materials
Hide Arm/Group Description:
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.

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).

Overall Number of Participants Analyzed 89 88
Mean (Standard Error)
Unit of Measure: units on a scale
-4.9164  (0.9782) -5.7495  (1.0106)
11.Secondary Outcome
Title Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 4
Hide Description 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.
Time Frame baseline to one year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was not collected in 6 participants from the usual care arm and 9 participants from the virtual visits arm.
Arm/Group Title Usual Care and Educational Materials Virtual Visits and Educational Materials
Hide Arm/Group Description:
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.

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).

Overall Number of Participants Analyzed 92 88
Mean (Standard Error)
Unit of Measure: units on a scale
-0.2075  (0.4042) -0.1825  (0.425)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Usual Care and Educational Materials Virtual Visits and Educational Materials
Hide Arm/Group Description 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.

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).

All-Cause Mortality
Usual Care and Educational Materials Virtual Visits and Educational Materials
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Usual Care and Educational Materials Virtual Visits and Educational Materials
Affected / at Risk (%) Affected / at Risk (%)
Total   0/98 (0.00%)   0/97 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Usual Care and Educational Materials Virtual Visits and Educational Materials
Affected / at Risk (%) Affected / at Risk (%)
Total   0/98 (0.00%)   0/97 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Ray Dorsey, MD
Organization: University of Rochester
Phone: 585-276-6824
Publications:
Eye on Practice: Virtual visits for Parkinson disease: A case series Vinayak Venkataraman, Sean J. Donohue, Kevin M. Biglan, Paul Wicks, and E. Ray Dorsey 10.1212/01.CPJ.0000437937.63347.5a; published ahead of print December 4, 2013
Responsible Party: Ray Dorsey, University of Rochester
ClinicalTrials.gov Identifier: NCT02038959     History of Changes
Other Study ID Numbers: AD-12-11-4701
First Submitted: January 8, 2014
First Posted: January 17, 2014
Results First Submitted: September 28, 2016
Results First Posted: January 27, 2017
Last Update Posted: January 27, 2017