Mobile Decision Support System for Nurse Management of Neuromodulation Therapy

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Device: iPad-Based Clinical Support Care; Other: Standard Clinical Care

• Registration Number: NCT02474459
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-06-14
• Study First Submitted QC: 2015-06-16
• Study First Posted: 2015-06-17
• Study Start: 2015-07
• Primary Completion: 2020-04-29
• Study Completion: 2020-04-29
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-03
• Last Update Posted: 2020-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iPad-based Clinical Support Care	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).
Standard Clinical Care	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).

Primary Outcome Measures

Name	Time	Method
Phase I: Difference in deep brain stimulation (DBS) programming time.	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.
Phase II: Difference in number of times the patient travels to the clinic.	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

Name	Time	Method
Differences in patient quality of life as measured by the Parkinson's Disease Questionnaire - 39 (PDQ-39).	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.
Differences in caregiver strain for DBS patients using the iPad-based clinical decision support tool	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.
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	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.

Trial Locations

Locations (6)

University of California San Francisco; 🇺🇸 San Francisco, California, United States

University of Utah Imaging and Neurosciences Center; 🇺🇸 Salt Lake City, Utah, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

NYU Langone Medical Center; 🇺🇸 New York, New York, United States

University of Florida Center for Movement Disorders & Neurorestoration; 🇺🇸 Gainesville, Florida, United States

Wake Forest School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States