Mobile Decision Support System for Nurse Management of Neuromodulation Therapy
2 other identifiers
interventional
123
1 country
6
Brief Summary
The purpose of this study is to test the use of a clinical decision support tool for postoperative care of Parkinson's disease patients who are treated using deep brain stimulation (DBS). The central hypothesis is that the use of a DBS clinical decision support system for individual patient management will enable considerable time savings and reduced burden on patients and caregivers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2015
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2015
CompletedFirst Posted
Study publicly available on registry
June 17, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 29, 2020
CompletedJune 5, 2020
June 1, 2020
4.8 years
June 14, 2015
June 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Phase I: Difference in deep brain stimulation (DBS) programming time.
Phase I: Difference in deep brain stimulation (DBS) programming time compared to standard care when the DBS programming nurse uses an iPad based decision support system.
6 months
Phase II: Difference in number of times the patient travels to the clinic.
Phase II: Difference in total number of times the patient travels to the University of Florida Movement Disorders clinic during the six month study period, except at baseline and 6 months (which were in clinic for everyone).
6 months
Secondary Outcomes (3)
Differences in caregiver strain for DBS patients using the iPad-based clinical decision support tool
6 months
Differences in outcomes for patients in the intervention groups compared to standard care as measured using the Unified Parkinson's Disease Rating Scale (UPDRS)
6 months
Differences in patient quality of life as measured by the Parkinson's Disease Questionnaire - 39 (PDQ-39).
6 months
Study Arms (2)
iPad-based Clinical Support Care
ACTIVE COMPARATORSubjects 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).
Standard Clinical Care
ACTIVE COMPARATORSubjects 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).
Interventions
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.
Subjects in this treatment arm will receive DBS programming at regular intervals as part of routine clinical care.
Eligibility Criteria
You may qualify if:
- Diagnosis of idiopathic Parkinson's Disease
- 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
You may not qualify if:
- Had a DBS device implanted at a non-participating site.
- Any previous DBS programming
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Utahlead
- University of Floridacollaborator
- National Institute of Nursing Research (NINR)collaborator
- Wake Forest University Health Sciencescollaborator
- Baylor College of Medicinecollaborator
- NYUcollaborator
- University of California, San Franciscocollaborator
Study Sites (6)
University of California San Francisco
San Francisco, California, 94115, United States
University of Florida Center for Movement Disorders & Neurorestoration
Gainesville, Florida, 32607, United States
NYU Langone Medical Center
New York, New York, 10016, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Utah Imaging and Neurosciences Center
Salt Lake City, Utah, 84108, United States
Related Publications (1)
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.
PMID: 34180949DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Butson, PhD
University of Utah Scientific Computing and Imaging Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 14, 2015
First Posted
June 17, 2015
Study Start
July 1, 2015
Primary Completion
April 29, 2020
Study Completion
April 29, 2020
Last Updated
June 5, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share