Mobile Decision Support System for Nurse Management of Neuromodulation Therapy
NCT ID: NCT02474459
Last Updated: 2020-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
123 participants
INTERVENTIONAL
2015-07-31
2020-04-29
Brief Summary
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Detailed Description
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Phase I:
Both the standard care and experimental groups will be medically evaluated identically, but the programming will be different between the groups as the experimental group will be programmed using the iPad. Patients in the control and experimental groups will be monitored with the same frequency at each participating clinic. Data and safety monitoring is the responsibility of each participating PI and the lead PI as the protocol involves minimal risk or no more than a minor increase over minimal risk. We anticipate that a single nurse at each site will perform DBS programming.
Phase II:
Patients in the experimental group will be evaluated and programmed by home health nurses in the patient's home setting. Neurological exams in the clinic will be performed at the first post-operative DBS programming session and 6 months later (the proposed end of the experimental period for each patient). During the intervening period, DBS programming and patient evaluations will be performed by a home health nurse. during this phase, data and safety monitoring will be conducted by a DSMB, which will meet regularly to review all cases and ensure safety. All subjects will be recruited directly through the participating sites' clinic systems, and all subjects will have oral and written informed consent before participation in the study. We anticipate that up to two home health registered nurses (RNs) will be performing DBS programming in phase 2.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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iPad-based Clinical Support Care
Subjects in this treatment arm will receive deep brain stimulation (DBS) programming at regular intervals as part of routine clinical care. DBS stimulation programming will be performed using an iPad-based decision support system. Outcomes will be measured using the Unified Parkinson's Disease Rating Scale (UPDRS), Parkinson's Disease Questionnaire (PDQ-39) and the Multi-Dimensional Caregiver Strain Index (MCSI).
iPad-Based Clinical Support Care
Subjects in this treatment arm will receive deep brain stimulation (DBS) programming at regular intervals as part of routine clinical care. DBS stimulation programming will be done with the use of a iPad-based decision support system.
Standard Clinical Care
Subjects in this treatment arm will receive DBS programming at regular intervals as part of routine clinical care. Outcomes will be measured using the Unified Parkinson's Disease Rating Scale (UPDRS), Parkinson's Disease Questionnaire (PDQ-39) and the Multi-Dimensional Caregiver Strain Index (MCSI).
Standard Clinical Care
Subjects in this treatment arm will receive DBS programming at regular intervals as part of routine clinical care.
Interventions
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iPad-Based Clinical Support Care
Subjects in this treatment arm will receive deep brain stimulation (DBS) programming at regular intervals as part of routine clinical care. DBS stimulation programming will be done with the use of a iPad-based decision support system.
Standard Clinical Care
Subjects in this treatment arm will receive DBS programming at regular intervals as part of routine clinical care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Planning to receive a DBS device at a participating site.
* Had a DBS device implanted, at a participating site, that hasn't been programmed yet
Exclusion Criteria
* Any previous DBS programming
30 Years
75 Years
ALL
No
Sponsors
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University of Florida
OTHER
National Institute of Nursing Research (NINR)
NIH
Wake Forest University Health Sciences
OTHER
Baylor College of Medicine
OTHER
NYU
UNKNOWN
University of California, San Francisco
OTHER
University of Utah
OTHER
Responsible Party
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Christopher Butson
Associate Professor
Principal Investigators
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Christopher Butson, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Utah Scientific Computing and Imaging Institute
Locations
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University of California San Francisco
San Francisco, California, United States
University of Florida Center for Movement Disorders & Neurorestoration
Gainesville, Florida, United States
NYU Langone Medical Center
New York, New York, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States
Baylor College of Medicine
Houston, Texas, United States
University of Utah Imaging and Neurosciences Center
Salt Lake City, Utah, United States
Countries
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References
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Duffley G, Lutz BJ, Szabo A, Wright A, Hess CW, Ramirez-Zamora A, Zeilman P, Chiu S, Foote KD, Okun MS, Butson CR. Home Health Management of Parkinson Disease Deep Brain Stimulation: A Randomized Clinical Trial. JAMA Neurol. 2021 Aug 1;78(8):972-981. doi: 10.1001/jamaneurol.2021.1910.
Other Identifiers
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IRB # 82859
Identifier Type: -
Identifier Source: org_study_id
NCT02066779
Identifier Type: -
Identifier Source: nct_alias
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