Connect.Parkinson: Connecting Individuals With Parkinson Disease to Specialists in Their Homes
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:
- 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;
- To show that such an approach can improve quality of life;
- To establish that the telemedicine can enhance the quality of care; and
- To demonstrate that this remote approach to care saves time, reduces travel, and decreases care partner burden.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
|Official Title:||Using Technology to Deliver Multi-disciplinary Care to Individuals With Parkinson Disease in Their Homes: the Connect.Parkinson Study|
- Feasibility of Virtual Visits for Parkinson Disease [ Time Frame: One year ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Assessed as the change in quality of life, measured by the Parkinson Disease Questionnaire 39 (PDQ-39).
- Overall Quality of Life [ Time Frame: One year ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Measured as the change in the Multidimensional Caregiver Strain Index (MCSI).
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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.
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).
No Intervention: Care partners
Care partners will be enrolled with the participants for whom they care. Care partners will complete a survey at baseline and at the end of the study, including assessments of time and travel for assisting with Parkinson disease visits and the Multidimensional Caregiver Strain Index (MCSI).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02038959
|Contact: Meredith A Achey, BMemail@example.com|
|United States, California|
|University of California San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|Principal Investigator: Nicholas B Galifianakis, MD|
|Principal Investigator: Caroline M Tanner, MD, PhD|
|Principal Investigator: Maya Katz, MD|
|The Parkinson's Institute and Clinical Center||Not yet recruiting|
|Sunnyvale, California, United States, 94083|
|Principal Investigator: James Tetrud, MD|
|United States, Florida|
|University of Florida||Not yet recruiting|
|Gainsville, Florida, United States, 32610|
|Principal Investigator: Ramon Rodriguez, MD|
|University of Miami||Not yet recruiting|
|Miami, Florida, United States, 33136|
|Principal Investigator: Carlos Singer, MD|
|United States, Georgia|
|Georgia Regents University||Recruiting|
|Augusta, Georgia, United States, 30912|
|Principal Investigator: John Morgan, MD, PhD|
|Sub-Investigator: Kapil D Sethi, MD|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator: Cindy Zadikoff, MD|
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator: Rajesh Pahwa, MD|
|United States, Maryland|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator: Zoltan Mari, MD|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator: Ludy Shih, MD|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator: Nicte Mejia Gonzalez, MD|
|United States, Minnesota|
|Struthers Parkinson Center||Recruiting|
|Golden Valley, Minnesota, United States, 55427|
|Principal Investigator: Martha A Nance, MD|
|Sub-Investigator: Sotirios Parashos, MD|
|Sub-Investigator: Daniel Kuyper, MD|
|The Mayo Clinic||Not yet recruiting|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator: Anhar Hassan, MB BCh|
|United States, New York|
|Northshore Long Island Jewish - Feinstein Institute||Recruiting|
|Manhasset, New York, United States, 11030|
|Principal Investigator: Andrew Feigin, MD|
|University of Rochester Medical Center||Recruiting|
|Rochester, New York, United States, 14642|
|Principal Investigator: Irene Richard, MD|
|Sub-Investigator: Rachel Biemiller, MD|
|Sub-Investigator: Kevin M Biglan, MD, MPH|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Principal Investigator: Patrick Hickey, DO|
|United States, Oregon|
|Oregon Health & Science University||Recruiting|
|Portland, Oregon, United States, 97239|
|Principal Investigator: Julie Carter, RN, MS, ANP|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator: Meredith Spindler, MD|
|United States, South Carolina|
|Medical University of South Carolina||Not yet recruiting|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator: Christina Vaughan, MD|
|United States, Texas|
|Baylor College of Medicine||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Joohi Jimenez-Shahed, MD|
|United States, Washington|
|Northwest Neurological, PLLC||Recruiting|
|Spokane, Washington, United States, 99202|
|Principal Investigator: Jason L Aldred, MD|
|Principal Investigator:||E. Ray Dorsey, MD, MBA||University of Rochester|