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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 Description
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Brief Summary:

Connect.Parkinson is a randomized comparative effectiveness study, comparing usual care enhanced with educational materials to usual care, educational materials, and the delivery of specialty care via telemedicine into patient's homes. The study's specific aims are the following:

  1. To demonstrate the feasibility of using telemedicine to deliver specialty care into the homes of individuals with Parkinson disease who have limited access to care;
  2. To show that such an approach can improve quality of life;
  3. To establish that the telemedicine can enhance the quality of care; and
  4. To demonstrate that this remote approach to care saves time, reduces travel, and decreases care partner burden.

Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Virtual Visits Not Applicable

Detailed Description:
Connect.Parkinson is a national study examining the feasibility and effectiveness of using video calls to bring expert Parkinson disease care directly into patients' homes. Currently, access to care for Parkinson disease is limited by distance, disability, and the distribution of doctors. Approximately 200 individuals with Parkinson disease (who due to distance, disability, disparity, or doctor distribution have limited access to care) will be randomized to one of two arms in this comparative effectiveness study. The first (control) arm will be the individual's "usual care" supplemented by educational materials on their condition. This usual care may include care from a generalist, care from a neurologist, or in-person care from a Parkinson specialist. The care received by the control group will vary but will be an accurate reflection of usual care in this country. The second (intervention) arm will be usual care supplemented by educational materials and care from a Parkinson disease specialist delivered via web-based video conferencing into the patient's home. The participants will also be asked with they have a primary care partner, and care partners will be invited to enroll, for a total of approximately 400 participants.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Using Technology to Deliver Multi-disciplinary Care to Individuals With Parkinson Disease in Their Homes: the Connect.Parkinson Study
Study Start Date : March 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: 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.
Experimental: 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.
 Other: 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).
Other Names:
  • Telemedicine
  • Teleneurology
  • Video call
  • Video conferencing


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility of Virtual Visits for Parkinson Disease [ Time Frame: One year ]
    Feasibility of virtual visits will be determined by the number of participants who complete at least one virtual visit successfully.

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


Secondary Outcome Measures :
  1. Change in EQ-5D Index Value [ Time Frame: baseline to one year ]
    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).

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

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

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

  5. Minutes Spend on Last Parkinson's Disease Provider Visit [ Time Frame: One year ]
  6. Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IB [ Time Frame: baseline to one year ]
    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.

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

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

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


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Individuals with clinically diagnosed Idiopathic Parkinson disease in the judgment of the independent rater
  • No better alternative explanation for the parkinsonism
  • Access to a non-public, internet-enabled device (e.g., computer, tablet computer, smart phone) that has the capacity for web-based video conferencing
  • Be physically located at time visits are conducted in a state where the participating physician is licensed to practice medicine
  • Have a local care provider that the study team can contact
  • Live at home, in a senior housing complex, or assisted living facility
  • Be fluent in English (all participating states) or Spanish (participants in Florida and Massachusetts only)
  • Willing and able to provide informed consent
  • Care partner (if applicable) must be able and willing to provide informed consent to participate if he or she so chooses.

Exclusion Criteria:

  • Currently hospitalized
  • Condition (e.g., prominent psychosis) that precludes study participation as identified by the medical professional (site investigator or nurse).
  • Participation in another telemedicine study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02038959


Locations
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Sponsors and Collaborators
University of Rochester
Patient-Centered Outcomes Research Institute
National Parkinson Foundation
Investigators
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Principal Investigator: E. Ray Dorsey, MD, MBA University of Rochester
More Information
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Publications:

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

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Responsible Party: Ray Dorsey, Director, Center for Human Experimental Therapeutics; Professor of Neurology, University of Rochester
ClinicalTrials.gov Identifier: NCT02038959    
Other Study ID Numbers: AD-12-11-4701
First Posted: January 17, 2014    Key Record Dates
Results First Posted: January 27, 2017
Last Update Posted: January 27, 2017
Last Verified: December 2016
Keywords provided by Ray Dorsey, University of Rochester:
Parkinson disease
Parkinson's
Parkinson's disease
telemedicine
 virtual visits
video calls
video conferencing
virtual house calls
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases