Mobile Decision Support System for Nurse Management of Neuromodulation Therapy
| Status: | Recruiting |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 30 - 75 |
| Updated: | 12/9/2018 |
| Start Date: | July 2015 |
| End Date: | December 2020 |
| Contact: | Gordon Duffley, MS |
| Email: | gordonduffley@gmail.com |
| Phone: | 603-858-5019 |
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.
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.
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 1 (in-clinic testing of iPad based decision support system) will occur from the 3rd
quarter of year 1 through the 2nd quarter of year 3. Phase 2 (in-home testing by a home
health nurse) will occur from the 1st quarter of year 3 through the 4th quarter of year 4.
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.
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 1 (in-clinic testing of iPad based decision support system) will occur from the 3rd
quarter of year 1 through the 2nd quarter of year 3. Phase 2 (in-home testing by a home
health nurse) will occur from the 1st quarter of year 3 through the 4th quarter of year 4.
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.
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
We found this trial at
5
sites
Winston-Salem, North Carolina 27157
Principal Investigator: Ihtsham Haq, MD
Phone: 336-716-3961
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1200 Moursund Street
Houston, Texas 77030
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Joohi Shahed-Jiminez, MD
Phone: 713-798-3951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Gainesville, Florida 32607
Principal Investigator: Michael S Okun, MD
Phone: 352-294-5030
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Salt Lake City, Utah 84108
Principal Investigator: Christopher R Butson, PhD
Phone: 603-858-5019
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