iPad Based Support System to Improve Outcomes From DBS Therapy
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 30 - 85 |
| Updated: | 11/28/2015 |
| Start Date: | June 2015 |
| End Date: | December 2018 |
| Contact: | Camille L Swartz, BS |
| Email: | cami.swartz@neurology.ufl.edu |
| Phone: | 352-273-5612 |
Mobile Decision Support System for Nurse Management of Neuromodulation
The purpose of this study is to test the use of a deep brain stimulation (DBS) clinical
decision support tool for bedside, postoperative care. The idea of this study is that the
use of a DBS clinical support system for individual patient management will enable
considerable time savings compared to standard care.
More specifically, the investigators will implement an iPad based decision support system
and measure it's effectiveness in an established clinic.
decision support tool for bedside, postoperative care. The idea of this study is that the
use of a DBS clinical support system for individual patient management will enable
considerable time savings compared to standard care.
More specifically, the investigators will implement an iPad based decision support system
and measure it's effectiveness in an established clinic.
If the subject decides to participate, they will follow the typical clinic visit schedule
for patients that have had DBS surgery. They will be expected to have several DBS
programming sessions to determine the best setting. These sessions will include completing
questionnaires and testing movement and coordination.
The investigators are comparing the 2 types of programming. Subjects will be "randomized"
into one of the two study groups. One group will have the DBS system programmed using
standard clinical care and one group will have the DBS system programmed using a iPAD
computerized system. Randomization means that one is put into a group by chance. It is like
flipping a coin. Subjects will have an equal chance of being placed in either group. Neither
the subject nor the investigator can choose what group a subject will be in.
A subject's standard clinical care will not change unless they are in the group that is
randomized to use the iPAD computerized system to select the settings. Both groups will
follow the same schedule of office visits that all subjects with DBS follow. For the group
which has their DBS programmed using the iPAD computerized system, the clinical decision
support tools will be used bedside during postoperative care. These tools will not provide
the final DBS settings and investigators do not anticipate that this approach will obviate
the need for motor exams. The clinical decision support system is meant to help programmers
choose good initial settings and then explore around those initial settings to optimize
patient care.
As part of usual patient care, some tests and questionnaires will be administered.
Investigators will use the results of those tests and questionnaires for this research
study.
The only difference between this study and routine clinical care at the UF Center for
Movement Disorders & Neurorestoration outpatient clinic is that a subject may be programmed
with the use of a computerized, iPad-based tool, and the time spent will be recorded in each
programming visit. The only additional questionnaire patients will be asked to complete
beyond what is normally performed in our clinic is the multi-dimensional caregiver strain
index (MCSI).
for patients that have had DBS surgery. They will be expected to have several DBS
programming sessions to determine the best setting. These sessions will include completing
questionnaires and testing movement and coordination.
The investigators are comparing the 2 types of programming. Subjects will be "randomized"
into one of the two study groups. One group will have the DBS system programmed using
standard clinical care and one group will have the DBS system programmed using a iPAD
computerized system. Randomization means that one is put into a group by chance. It is like
flipping a coin. Subjects will have an equal chance of being placed in either group. Neither
the subject nor the investigator can choose what group a subject will be in.
A subject's standard clinical care will not change unless they are in the group that is
randomized to use the iPAD computerized system to select the settings. Both groups will
follow the same schedule of office visits that all subjects with DBS follow. For the group
which has their DBS programmed using the iPAD computerized system, the clinical decision
support tools will be used bedside during postoperative care. These tools will not provide
the final DBS settings and investigators do not anticipate that this approach will obviate
the need for motor exams. The clinical decision support system is meant to help programmers
choose good initial settings and then explore around those initial settings to optimize
patient care.
As part of usual patient care, some tests and questionnaires will be administered.
Investigators will use the results of those tests and questionnaires for this research
study.
The only difference between this study and routine clinical care at the UF Center for
Movement Disorders & Neurorestoration outpatient clinic is that a subject may be programmed
with the use of a computerized, iPad-based tool, and the time spent will be recorded in each
programming visit. The only additional questionnaire patients will be asked to complete
beyond what is normally performed in our clinic is the multi-dimensional caregiver strain
index (MCSI).
Inclusion Criteria:
- Diagnosis of idiopathic Parkinson's Disease
- Planning to receive a DBS device at Shands/University of Florida (UF), or
- Had a DBS device implanted, at Shands/UF, that hasn't been programmed yet
Exclusion Criteria:
- Had a DBS device implanted at a site other than Shands/UF
- Any previous DBS programming
We found this trial at
2
sites
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