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

Parkinson Disease Clinical Trial

Official title:

Using Technology to Deliver Multi-disciplinary Care to Individuals With Parkinson Disease in Their Homes: the Connect.Parkinson Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02038959
• Other study ID #: AD-12-11-4701
• Status: Active, not recruiting
• Phase: N/A
• First received: January 8, 2014
• Last updated: July 8, 2016
• Start date: March 2014
• Est. completion date: August 2016

Study information

• Verified date: July 2016
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 480
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• 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).

Locations

Country	Name	City	State
United States	Georgia Regents University	Augusta	Georgia
United States	Johns Hopkins	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern University	Chicago	Illinois
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Florida	Gainsville	Florida
United States	Struthers Parkinson Center	Golden Valley	Minnesota
United States	Baylor College of Medicine	Houston	Texas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Northshore Long Island Jewish - Feinstein Institute	Manhasset	New York
United States	University of Miami	Miami	Florida
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	The Mayo Clinic	Rochester	Minnesota
United States	University of Rochester Medical Center	Rochester	New York
United States	University of California San Francisco	San Francisco	California
United States	Northwest Neurological, PLLC	Spokane	Washington
United States	The Parkinson's Institute and Clinical Center	Sunnyvale	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Rochester	National Parkinson Foundation, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View Citation

Eye on Practice: Virtual visits for Parkinson disease: A case series Vinayak Venkataraman, Sean J. Donohue, Kevin M. Biglan, Paul Wicks, and E. Ray Dorsey 10.1212/01.CPJ.0000437937.63347.5a; published ahead of print December 4, 2013

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Efficacy of care provided via virtual visits	Assessed as the change in quality of life, measured by the Parkinson Disease Questionnaire 39 (PDQ-39).	One year	No
Secondary	Overall Quality of Life	We will measure the change in overall quality of life reported from baseline to the end of the study using the EuroQoL 5D-5L.	One year	No
Secondary	Patient Global Impression of Change	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.	One year	No
Secondary	Cognition	We will assess changes in cognition from baseline to the end of the study using the Montreal Cognitive Assessment (MoCA), administered remotely.	One year	No
Secondary	Parkinson disease severity	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).	One year	No
Secondary	Quality of Care	We will assess change in the perceived quality of care using the Patient Assessment of Chronic Illness Care (PACIC).	One year	No
Secondary	Value to patients and care partners	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).	One year	No
Secondary	Care partner burden	Measured as the change in the Multidimensional Caregiver Strain Index (MCSI).	One year	No

External Links

•   Connect.Parkinson Website