Clinical trial NCT02038959: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson disease
Parkinson's
Parkinson's disease
telemedicine
virtual visits
video calls
video conferencing
virtual house calls
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: National Parkinson Foundation
First posted: 2014-01-17
Enrollment: 210
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Feasibility of Virtual Visits for Parkinson Disease
timeFrame: One year
measure: Change From Baseline in the Quality of Life Measured by Parkinson Disease Questionnaire 39
timeFrame: Baseline to One year
Secondary outcomes:
measure: Change in EQ-5D Index Value
timeFrame: baseline to one year
measure: Change in Montreal Cognition Assessment
timeFrame: baseline to one year
measure: Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IA
timeFrame: baseline to one year
measure: Change in Patient Assessment of Chronic Illness Care
timeFrame: baseline to one year
measure: Minutes Spend on Last Parkinson's Disease Provider Visit
timeFrame: One year
measure: Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IB
timeFrame: baseline to one year
measure: Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 2
timeFrame: baseline to one year
measure: Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 3
timeFrame: baseline to one year
measure: Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 4
timeFrame: baseline to one year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Sunnyvale
country: United States
facility: The Parkinson's Institute and Clinical Center
state: California
city: Gainsville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Augusta
country: United States
facility: Georgia Regents University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Golden Valley
country: United States
facility: Struthers Parkinson Center
state: Minnesota
city: Rochester
country: United States
facility: The Mayo Clinic
state: Minnesota
city: Manhasset
country: United States
facility: Northshore Long Island Jewish - Feinstein Institute
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Spokane
country: United States
facility: Northwest Neurological, PLLC
state: Washington
Study officials:
affiliation: University of Rochester
name: E. Ray Dorsey, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.