Clinical trial NCT02474459: Mobile Decision Support System for Nurse Management of Neuromodulation Therapy
Official title: Mobile Decision Support System for Nurse Management of Neuromodulation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Deep Brain Stimulation
DBS
STN
GPi
Globus pallidus
Subthalamic nucleus
Neuromodulation
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: University of Florida
name: National Institute of Nursing Research (NINR)
name: Wake Forest University Health Sciences
name: Baylor College of Medicine
name: NYU
name: University of California, San Francisco
First posted: 2015-06-17
Enrollment: 123
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The proposed study will evaluate outcomes for Parkinson's disease (PD) patients who are treated with unilateral deep brain stimulation (DBS); patients who consent to the study will be randomized to standard care or the experimental group. The study will occur in two phases.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Had a DBS device implanted at a non-participating site.
* Any previous DBS programming

Primary outcomes:
measure: Phase I: Difference in deep brain stimulation (DBS) programming time.
timeFrame: 6 months
measure: Phase II: Difference in number of times the patient travels to the clinic.
timeFrame: 6 months
Secondary outcomes:
measure: Differences in caregiver strain for DBS patients using the iPad-based clinical decision support tool
timeFrame: 6 months
measure: Differences in outcomes for patients in the intervention groups compared to standard care as measured using the Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: 6 months
measure: Differences in patient quality of life as measured by the Parkinson's Disease Questionnaire - 39 (PDQ-39).
timeFrame: 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Gainesville
country: United States
facility: University of Florida Center for Movement Disorders & Neurorestoration
state: Florida
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Imaging and Neurosciences Center
state: Utah
Study officials:
affiliation: University of Utah Scientific Computing and Imaging Institute
name: Christopher Butson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.