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

Tracking Information

• First Submitted Date: January 8, 2014
• First Posted Date: January 17, 2014
• Results First Submitted Date: September 28, 2016
• Results First Posted Date: January 27, 2017
• Last Update Posted Date: January 27, 2017
• Study Start Date: March 2014
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 1, 2016)

• 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.
• 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.

Original Primary Outcome Measures (submitted: January 15, 2014)

• 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.
• Efficacy of care provided via virtual visits [ Time Frame: One year ]
  Assessed as the change in quality of life, measured by the Parkinson Disease Questionnaire 39 (PDQ-39).

Current Secondary Outcome Measures (submitted: December 1, 2016)

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

Original Secondary Outcome Measures (submitted: January 15, 2014)

• Overall Quality of Life [ Time Frame: One year ]
  We will measure the change in overall quality of life reported from baseline to the end of the study using the EuroQoL 5D-5L.
• Patient Global Impression of Change [ Time Frame: One year ]
  At the conclusion of the study, participants will be asked to describe how they feel their health has changed since the beginning of the study.
• Cognition [ Time Frame: One year ]
  We will assess changes in cognition from baseline to the end of the study using the Montreal Cognitive Assessment (MoCA), administered remotely.
• Parkinson disease severity [ Time Frame: 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).
• Quality of Care [ Time Frame: One year ]
  We will assess change in the perceived quality of care using the Patient Assessment of Chronic Illness Care (PACIC).
• Value to patients and care partners [ Time Frame: One year ]
  We will assess value to patients and caregivers using questions about time and travel to Parkinson disease appointments, as well as healthcare resource utilization (including hospitalizations and other visits).
• Care partner burden [ Time Frame: One year ]
  Measured as the change in the Multidimensional Caregiver Strain Index (MCSI).

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Connect.Parkinson: Connecting Individuals With Parkinson Disease to Specialists in Their Homes
• Official Title: Using Technology to Deliver Multi-disciplinary Care to Individuals With Parkinson Disease in Their Homes: the Connect.Parkinson Study

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.

• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Health Services Research
• Condition: Parkinson Disease

Intervention

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

Study Arms

• 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.
  Intervention: Other: Virtual Visits

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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 1, 2016): 210
• Original Estimated Enrollment (submitted: January 15, 2014): 480
• Actual Study Completion Date: August 2016
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02038959
• Other Study ID Numbers: AD-12-11-4701
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Ray Dorsey, University of Rochester
• Original Responsible Party: University of Rochester
• Current Study Sponsor: University of Rochester
• Original Study Sponsor: Same as current

Collaborators

• Patient-Centered Outcomes Research Institute
• National Parkinson Foundation

Investigators

• Principal Investigator: E. Ray Dorsey, MD, MBA; University of Rochester

• PRS Account: University of Rochester
• Verification Date: December 2016