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Mobile Decision Support System for Nurse Management of Neuromodulation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02474459
Recruitment Status : Completed
First Posted : June 17, 2015
Last Update Posted : June 5, 2020
Sponsor:
Collaborators:
University of Florida
National Institute of Nursing Research (NINR)
Wake Forest University Health Sciences
Baylor College of Medicine
NYU
University of California, San Francisco
Information provided by (Responsible Party):
Christopher Butson, University of Utah

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Device: iPad-Based Clinical Support Care Other: Standard Clinical Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mobile Decision Support System for Nurse Management of Neuromodulation Therapy
Actual Study Start Date : July 2015
Actual Primary Completion Date : April 29, 2020
Actual Study Completion Date : April 29, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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).
Device: 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.
Other Name: iPad-Based Tool

Active Comparator: 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).
Other: Standard Clinical Care
Subjects in this treatment arm will receive DBS programming at regular intervals as part of routine clinical care.




Primary Outcome Measures :
  1. Phase I: Difference in deep brain stimulation (DBS) programming time. [ Time Frame: 6 months ]
    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.

  2. Phase II: Difference in number of times the patient travels to the clinic. [ Time Frame: 6 months ]
    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).


Secondary Outcome Measures :
  1. Differences in caregiver strain for DBS patients using the iPad-based clinical decision support tool [ Time Frame: 6 months ]
    The Multi-Dimensional Caregiver Strain Index (MCSI) is an 18-question self-report scale with 6 subscales of caregiver strain: physical strain, social constraints, financial strain, time constraints, interpersonal strain, and elder demanding/manipulative behavior. A higher score is considered indicative of a greater caregiver strain. MCSI scores range from 0 to 72. Higher scores indicate worse outcomes.

  2. Differences in outcomes for patients in the intervention groups compared to standard care as measured using the Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 6 months ]
    The Unified Parkinson's Disease Rating Scale (UPDRS) is a rating scale used to follow the longitudinal course of Parkinson's disease. The UPDRS is made up of 5 sections: (1) Evaluation of Mentation, behavior, and mood; (2) Self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, cutting food; (3) Clinician-scored monitored motor evaluation; (4) Hoehn and Yahr staging of severity of Parkinson disease; (5) Schwab and England ADL scale. The higher the UPDRS score, the greater the disability from PD. UPDRS scores range from 0 to 199. Higher scores indicate worse outcomes.

  3. Differences in patient quality of life as measured by the Parkinson's Disease Questionnaire - 39 (PDQ-39). [ Time Frame: 6 months ]
    The Parkinson's Disease Questionnaire - 39 (PDQ-39) is a patient self-reported rating scale that measures impairment in quality of life caused by Parkinson's disease. Scores range from 0 to 100. Higher scores indicate worse outcomes.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02474459


Locations
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United States, California
University of California San Francisco
San Francisco, California, United States, 94115
United States, Florida
University of Florida Center for Movement Disorders & Neurorestoration
Gainesville, Florida, United States, 32607
United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
United States, North Carolina
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Utah
University of Utah Imaging and Neurosciences Center
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
University of Florida
National Institute of Nursing Research (NINR)
Wake Forest University Health Sciences
Baylor College of Medicine
NYU
University of California, San Francisco
Investigators
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Principal Investigator: Christopher Butson, PhD University of Utah Scientific Computing and Imaging Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Christopher Butson, Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT02474459    
Obsolete Identifiers: NCT02066779
Other Study ID Numbers: IRB # 82859
R01NR014852 ( U.S. NIH Grant/Contract )
First Posted: June 17, 2015    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christopher Butson, University of Utah:
Deep Brain Stimulation
DBS
STN
GPi
Globus pallidus
Subthalamic nucleus
Neuromodulation
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases