Mobile Decision Support System for Nurse Management of Neuromodulation Therapy

Parkinson's Disease Clinical Trial

Official title:

Mobile Decision Support System for Nurse Management of Neuromodulation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02474459
• Other study ID #: IRB # 82859
• Secondary ID: R01NR014852
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: April 29, 2020

Study information

• Verified date: June 2020
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT02066779

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: April 29, 2020
• Est. primary completion date: April 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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

Locations

Country	Name	City	State
United States	University of Florida Center for Movement Disorders & Neurorestoration	Gainesville	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	NYU Langone Medical Center	New York	New York
United States	University of Utah Imaging and Neurosciences Center	Salt Lake City	Utah
United States	University of California San Francisco	San Francisco	California
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (7)

Lead Sponsor	Collaborator
University of Utah	Baylor College of Medicine, National Institute of Nursing Research (NINR), NYU, University of California, San Francisco, University of Florida, Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Differences in caregiver strain for DBS patients using the iPad-based clinical decision support tool	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.	6 months
Secondary	Differences in outcomes for patients in the intervention groups compared to standard care as measured using the Unified Parkinson's Disease Rating Scale (UPDRS)	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.	6 months
Secondary	Differences in patient quality of life as measured by the Parkinson's Disease Questionnaire - 39 (PDQ-39).	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.	6 months