ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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).


Participant Flow:   Overall Study
    Usual Care and Educational Materials   Virtual Visits and Educational Materials
STARTED   98   97 
COMPLETED   92   89 
NOT COMPLETED   6   8 
Withdrawal by Subject                6                8 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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).

Total Total of all reporting groups

Baseline Measures
   Usual Care and Educational Materials   Virtual Visits and Educational Materials   Total 
Overall Participants Analyzed 
[Units: Participants]
 98   97   195 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.9  (8.5)   65.9  (7.8)   66.4  (8.1) 
Gender 
[Units: Participants]
Count of Participants
     
Female      42  42.9%      49  50.5%      91  46.7% 
Male      56  57.1%      48  49.5%      104  53.3% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   98   97   195 
Minutes spent with Parkinson disease provider [1] 
[Units: Minutes]
Median (Inter-Quartile Range)
 30 
 (20 to 45) 
 30 
 (20 to 45) 
 30 
 (20 to 45) 
[1] 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:   Feasibility of Virtual Visits for Parkinson Disease   [ Time Frame: One year ]

2.  Primary:   Change From Baseline in the Quality of Life Measured by Parkinson Disease Questionnaire 39   [ Time Frame: Baseline to One year ]

3.  Secondary:   Change in EQ-5D Index Value   [ Time Frame: baseline to one year ]

4.  Secondary:   Change in Montreal Cognition Assessment   [ Time Frame: baseline to one year ]

5.  Secondary:   Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IA   [ Time Frame: baseline to one year ]

6.  Secondary:   Change in Patient Assessment of Chronic Illness Care   [ Time Frame: baseline to one year ]

7.  Secondary:   Minutes Spend on Last Parkinson's Disease Provider Visit   [ Time Frame: One year ]

8.  Secondary:   Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IB   [ Time Frame: baseline to one year ]

9.  Secondary:   Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 2   [ Time Frame: baseline to one year ]

10.  Secondary:   Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 3   [ Time Frame: baseline to one year ]

11.  Secondary:   Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 4   [ Time Frame: baseline to one year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  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
e-mail: ray.dorsey@chet.rochester.edu


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

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

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