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

• 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: University of Rochester
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Usual Care and Educational Materials	Virtual Visits and Educational Materials	Total
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
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.

Outcome Measures

1. Primary Outcome

Title	Feasibility of Virtual Visits for Parkinson Disease
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care and Educational Materials	Virtual Visits and Educational Materials
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
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

Outcome Measure Data

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
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)

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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	One year

Outcome Measure Data

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
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)

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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Usual Care and Educational Materials	Virtual Visits and Educational Materials
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	--/--	--/--
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%)
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%)

Limitations and Caveats

[Not Specified]

More Information

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
• EMail: ray.dorsey@chet.rochester.edu

Publications:

Dorsey ER, Venkataraman V, Grana MJ, Bull MT, George BP, Boyd CM, Beck CA, Rajan B, Seidmann A, Biglan KM. Randomized controlled clinical trial of "virtual house calls" for Parkinson disease. JAMA Neurol. 2013 May;70(5):565-70. doi: 10.1001/jamaneurol.2013.123.

Grana MJ, Bull MT, Venkataraman V, Dorsey ER, Biglan KM. Web-based clinical assessments for Parkinson's disease: reliable and feasible. Mov Disord. 2012 Sep 15;27(11):1466. doi: 10.1002/mds.25121. Epub 2012 Sep 18. No abstract available.

Abdolahi A, Scoglio N, Killoran A, Dorsey ER, Biglan KM. Potential reliability and validity of a modified version of the Unified Parkinson's Disease Rating Scale that could be administered remotely. Parkinsonism Relat Disord. 2013 Feb;19(2):218-21. doi: 10.1016/j.parkreldis.2012.10.008. Epub 2012 Oct 25.

Willis AW, Schootman M, Tran R, Kung N, Evanoff BA, Perlmutter JS, Racette BA. Neurologist-associated reduction in PD-related hospitalizations and health care expenditures. Neurology. 2012 Oct 23;79(17):1774-80. doi: 10.1212/WNL.0b013e3182703f92. Epub 2012 Oct 10.

Willis AW, Schootman M, Evanoff BA, Perlmutter JS, Racette BA. Neurologist care in Parkinson disease: a utilization, outcomes, and survival study. Neurology. 2011 Aug 30;77(9):851-7. doi: 10.1212/WNL.0b013e31822c9123. Epub 2011 Aug 10.

Venkataraman V, Donohue SJ, Biglan KM, Wicks P, Dorsey ER. Virtual visits for Parkinson disease: A case series. Neurol Clin Pract. 2014 Apr;4(2):146-152. doi: 10.1212/01.CPJ.0000437937.63347.5a.

Achey MA, Beck CA, Beran DB, Boyd CM, Schmidt PN, Willis AW, Riggare SS, Simone RB, Biglan KM, Dorsey ER. Virtual house calls for Parkinson disease (Connect.Parkinson): study protocol for a randomized, controlled trial. Trials. 2014 Nov 27;15:465. doi: 10.1186/1745-6215-15-465. Erratum In: Trials. 2016;17:7.

Achey MA, Beck CA, Beran DB, Boyd CM, Schmidt PN, Willis AW, Riggare SS, Simone RB, Biglan KM, Dorsey ER. Erratum To: Virtual house calls for Parkinson disease (Connect.Parkinson): study protocol for a randomized, controlled trial. Trials. 2016 Jan 5;17:7. doi: 10.1186/s13063-015-0984-7. No abstract available.

Dorsey ER, Achey MA, Beck CA, Beran DB, Biglan KM, Boyd CM, Schmidt PN, Simone R, Willis AW, Galifianakis NB, Katz M, Tanner CM, Dodenhoff K, Ziman N, Aldred J, Carter J, Jimenez-Shahed J, Hunter C, Spindler M, Mari Z, Morgan JC, McLane D, Hickey P, Gauger L, Richard IH, Bull MT, Mejia NI, Bwala G, Nance M, Shih L, Anderson L, Singer C, Zadikoff C, Okon N, Feigin A, Ayan J, Vaughan C, Pahwa R, Cooper J, Webb S, Dhall R, Hassan A, Weis D, DeMello S, Riggare SS, Wicks P, Smith J, Keenan HT, Korn R, Schwarz H, Sharma S, Stevenson EA, Zhu W. National Randomized Controlled Trial of Virtual House Calls for People with Parkinson's Disease: Interest and Barriers. Telemed J E Health. 2016 Jul;22(7):590-8. doi: 10.1089/tmj.2015.0191. Epub 2016 Feb 17.

Daschle T, Dorsey ER. The return of the house call. Ann Intern Med. 2015 Apr 21;162(8):587-8. doi: 10.7326/M14-2769. No abstract available.

Dorsey ER, Topol EJ. State of Telehealth. N Engl J Med. 2016 Jul 14;375(2):154-61. doi: 10.1056/NEJMra1601705. No abstract available.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Beck CA, Beran DB, Biglan KM, Boyd CM, Dorsey ER, Schmidt PN, Simone R, Willis AW, Galifianakis NB, Katz M, Tanner CM, Dodenhoff K, Aldred J, Carter J, Fraser A, Jimenez-Shahed J, Hunter C, Spindler M, Reichwein S, Mari Z, Dunlop B, Morgan JC, McLane D, Hickey P, Gauger L, Richard IH, Mejia NI, Bwala G, Nance M, Shih LC, Singer C, Vargas-Parra S, Zadikoff C, Okon N, Feigin A, Ayan J, Vaughan C, Pahwa R, Dhall R, Hassan A, DeMello S, Riggare SS, Wicks P, Achey MA, Elson MJ, Goldenthal S, Keenan HT, Korn R, Schwarz H, Sharma S, Stevenson EA, Zhu W; Connect.Parkinson Investigators. National randomized controlled trial of virtual house calls for Parkinson disease. Neurology. 2017 Sep 12;89(11):1152-1161. doi: 10.1212/WNL.0000000000004357. Epub 2017 Aug 16.

• Responsible Party: Ray Dorsey, University of Rochester
• ClinicalTrials.gov Identifier: NCT02038959
• 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