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

NCT ID: NCT02038959

Last Updated: 2017-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-08-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Virtual Visits

Intervention Type: 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).

Interventions

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).

Intervention Type: OTHER

Other Intervention Names

Telemedicine; Teleneurology; Video call; Video conferencing

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

National Parkinson Foundation

OTHER

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Ray Dorsey

Director, Center for Human Experimental Therapeutics; Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

E. Ray Dorsey, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of California San Francisco

San Francisco, California, United States

The Parkinson's Institute and Clinical Center

Sunnyvale, California, United States

University of Florida

Gainsville, Florida, United States

University of Miami

Miami, Florida, United States

Georgia Regents University

Augusta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Johns Hopkins

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Struthers Parkinson Center

Golden Valley, Minnesota, United States

The Mayo Clinic

Rochester, Minnesota, United States

Northshore Long Island Jewish - Feinstein Institute

Manhasset, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Oregon Health & Science University

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Baylor College of Medicine

Houston, Texas, United States

Northwest Neurological, PLLC

Spokane, Washington, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23479138 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22991090 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23102808 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23054239 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21832214 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24790799 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25431346 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26733455 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26886406 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25894028 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27410924 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28814455 (View on PubMed)

Other Identifiers

AD-12-11-4701

Identifier Type: -

Identifier Source: org_study_id