Trial Outcomes & Findings for Connect.Parkinson: Connecting Individuals With Parkinson Disease to Specialists in Their Homes (NCT NCT02038959)

Results Overview

Feasibility of virtual visits will be determined by the number of participants who complete at least one virtual visit successfully.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

210 participants

Primary outcome timeframe

One year

Results posted on

2017-01-27

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	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).
Overall Study STARTED	98	97
Overall Study COMPLETED	92	89
Overall Study NOT COMPLETED	6	8

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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).
Overall Study Withdrawal by Subject	6	8

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care and Educational Materials n=98 Participants 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.	Virtual Visits and Educational Materials n=97 Participants 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 n=195 Participants Total of all reporting groups
Age, Continuous	66.9 years STANDARD_DEVIATION 8.5 • n=5 Participants	65.9 years STANDARD_DEVIATION 7.8 • n=7 Participants	66.4 years STANDARD_DEVIATION 8.1 • n=5 Participants
Gender Female	42 Participants n=5 Participants	49 Participants n=7 Participants	91 Participants n=5 Participants
Gender Male	56 Participants n=5 Participants	48 Participants n=7 Participants	104 Participants n=5 Participants
Region of Enrollment United States	98 Participants n=5 Participants	97 Participants n=7 Participants	195 Participants n=5 Participants
Minutes spent with Parkinson disease provider	30 minutes n=5 Participants	30 minutes n=7 Participants	30 minutes n=5 Participants

PRIMARY outcome

Timeframe: One year

Feasibility of virtual visits will be determined by the number of participants who complete at least one virtual visit successfully.

Outcome measures

Outcome measures
Measure	Usual Care and Educational Materials n=98 Participants 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.	Virtual Visits and Educational Materials n=97 Participants 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).
Feasibility of Virtual Visits for Parkinson Disease	0 participants	95 participants

PRIMARY outcome

Timeframe: Baseline to One year

Population: Data was not collected on 17 participants in the usual care arm and 18 participants in the virtual visits arm.

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.

Outcome measures

Outcome measures
Measure	Usual Care and Educational Materials n=81 Participants 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.	Virtual Visits and Educational Materials n=79 Participants 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).
Change From Baseline in the Quality of Life Measured by Parkinson Disease Questionnaire 39	-0.7512 units on a scale Standard Error 0.9472	-0.4123 units on a scale Standard Error 1.0029

SECONDARY outcome

Timeframe: baseline to one year

Population: Data was not collected in 6 participants from the usual care arm and 9 participants from the virtual visits arm.

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).

Outcome measures

Outcome measures
Measure	Usual Care and Educational Materials n=92 Participants 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.	Virtual Visits and Educational Materials n=88 Participants 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).
Change in EQ-5D Index Value	-0.04122 units on a scale Standard Error 0.01074	-0.02728 units on a scale Standard Error 0.01139

SECONDARY outcome

Timeframe: baseline to one year

Population: Data was not collected on 6 participants in the usual care arm and 9 participants in the virtual visits arm.

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.

Outcome measures

Outcome measures
Measure	Usual Care and Educational Materials n=92 Participants 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.	Virtual Visits and Educational Materials n=88 Participants 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).
Change in Montreal Cognition Assessment	0.2072 units on a scale Standard Error 0.243	0.6485 units on a scale Standard Error 0.2566

SECONDARY outcome

Timeframe: baseline to one year

Population: Data was not collected in 6 participants from the usual care arm and 8 participants from the virtual visits arm.

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.

Outcome measures

Outcome measures
Measure	Usual Care and Educational Materials n=92 Participants 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.	Virtual Visits and Educational Materials n=89 Participants 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).
Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IA	-1.0122 units on a scale Standard Error 0.2979	-0.8546 units on a scale Standard Error 0.3117

SECONDARY outcome

Timeframe: baseline to one year

Population: Data was not collected in 16 participants from the usual care arm and 12 participants from the virtual visits arm.

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.

Outcome measures

Outcome measures
Measure	Usual Care and Educational Materials n=82 Participants 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.	Virtual Visits and Educational Materials n=85 Participants 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).
Change in Patient Assessment of Chronic Illness Care	0.2456 units on a scale Standard Error 0.1001	0.2795 units on a scale Standard Error 0.1035

SECONDARY outcome

Timeframe: One year

Population: Data was not collected on 10 participants in the usual care arm and 28 participants in the virtual visits arm.

Outcome measures

Outcome measures
Measure	Usual Care and Educational Materials n=88 Participants 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.	Virtual Visits and Educational Materials n=69 Participants 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).
Minutes Spend on Last Parkinson's Disease Provider Visit	30 minutes Interval 20.0 to 45.0	30 minutes Interval 20.0 to 40.0

SECONDARY outcome

Timeframe: baseline to one year

Population: Data was not collected in 11 participants from the usual care arm and 7 participants from the virtual visits arm.

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.

Outcome measures

Outcome measures
Measure	Usual Care and Educational Materials n=87 Participants 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.	Virtual Visits and Educational Materials n=90 Participants 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).
Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IB	0.389 units on a scale Standard Error 0.3701	0.1243 units on a scale Standard Error 0.3786

SECONDARY outcome

Timeframe: baseline to one year

Population: Data was not collected in 12 participants from the usual care arm and 7 participants from the virtual visits arm.

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.

Outcome measures

Outcome measures
Measure	Usual Care and Educational Materials n=86 Participants 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.	Virtual Visits and Educational Materials n=90 Participants 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).
Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 2	-0.3266 units on a scale Standard Error 0.5084	0.1378 units on a scale Standard Error 0.512

SECONDARY outcome

Timeframe: baseline to one year

Population: Data was not collected in 9 participants from the usual care arm and 9 participants from the virtual visits arm.

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.

Outcome measures

Outcome measures
Measure	Usual Care and Educational Materials n=89 Participants 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.	Virtual Visits and Educational Materials n=88 Participants 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).
Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 3	-4.9164 units on a scale Standard Error 0.9782	-5.7495 units on a scale Standard Error 1.0106

SECONDARY outcome

Timeframe: baseline to one year

Population: Data was not collected in 6 participants from the usual care arm and 9 participants from the virtual visits arm.

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.

Outcome measures

Outcome measures
Measure	Usual Care and Educational Materials n=92 Participants 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.	Virtual Visits and Educational Materials n=88 Participants 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).
Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 4	-0.2075 units on a scale Standard Error 0.4042	-0.1825 units on a scale Standard Error 0.425

Adverse Events

Usual Care and Educational Materials

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Virtual Visits and Educational Materials

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ray Dorsey, MD

University of Rochester

Phone: 585-276-6824

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place