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

NCT02038959 | Completed Results

• 1 other identifier: AD-12-11-4701
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 20

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. 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. 2.To show that such an approach can improve quality of life;
3. 3.To establish that the telemedicine can enhance the quality of care; and
4. 4.To demonstrate that this remote approach to care saves time, reduces travel, and decreases care partner burden.

Conditions

Parkinson Disease

Keywords

Parkinson disease; Parkinson's; Parkinson's disease; telemedicine; virtual visits; video calls; video conferencing; virtual house calls

Outcome Measures

Primary Outcomes (2)

• Feasibility of Virtual Visits for Parkinson Disease

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

  One year

• Change From Baseline in the Quality of Life Measured by Parkinson Disease Questionnaire 39

  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.

  Baseline to One year

Secondary Outcomes (9)

• Change in EQ-5D Index Value

  baseline to one year

• Change in Montreal Cognition Assessment

  baseline to one year

• Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IA

  baseline to one year

• Change in Patient Assessment of Chronic Illness Care

  baseline to one year

• Minutes Spend on Last Parkinson's Disease Provider Visit

  One year

Study Arms (2)

Usual Care and Educational Materials

NO INTERVENTION

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

EXPERIMENTAL

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

Interventions

Virtual Visits OTHER

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).

Also known as: Telemedicine, Teleneurology, Video call, Video conferencing

Virtual Visits and Educational Materials

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• Patient-Centered Outcomes Research Institute: collaborator
• National Parkinson Foundation: collaborator

Study Sites (20)

University of California San Francisco

San Francisco, California, 94143, United States

Location

The Parkinson's Institute and Clinical Center

Sunnyvale, California, 94083, United States

Location

University of Florida

Gainsville, Florida, 32610, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Georgia Regents University

Augusta, Georgia, 30912, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Struthers Parkinson Center

Golden Valley, Minnesota, 55427, United States

Location

The Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Northshore Long Island Jewish - Feinstein Institute

Manhasset, New York, 11030, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Northwest Neurological, PLLC

Spokane, Washington, 99202, United States

Location

Related Publications (12)

• 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.

  PMID: 23479138 BACKGROUND

• 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.

  PMID: 22991090 BACKGROUND

• 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.

  PMID: 23102808 BACKGROUND

• 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.

  PMID: 23054239 BACKGROUND

• 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.

  PMID: 21832214 BACKGROUND

• 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.

  PMID: 24790799 BACKGROUND

• 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.

  PMID: 25431346 BACKGROUND

• 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.

  PMID: 26733455 BACKGROUND

• 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.

  PMID: 26886406 BACKGROUND

• 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.

  PMID: 25894028 BACKGROUND

• 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.

  PMID: 27410924 BACKGROUND

• 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.

  PMID: 28814455 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Ray Dorsey, MD
• Organization: University of Rochester

ray.dorsey@chet.rochester.edu

585-276-6824

Study Officials

• E. Ray Dorsey, MD, MBA

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Human Experimental Therapeutics; Professor of Neurology

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 17, 2014
• Study Start: March 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 27, 2017
• Results First Posted: January 27, 2017

Record last verified: 2016-12

Locations

US (20)