Parkinson's DiseaseNCT02474459
Mobile Decision Support System for Nurse Management of Neuromodulation Therapy
A study testing iPad-Based Clinical Support Care and Standard Clinical Care in people with Parkinson's Disease, run by University of Utah at 6 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- iPad-Based Clinical Support Care and Standard Clinical Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2015to 29 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Had a DBS device implanted at a non-participating site.
- Any previous DBS programming
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Florida Center for Movement Disorders & Neurorestoration
Gainesville, Florida, 32607
Baylor College of Medicine
Houston, Texas, 77030
NYU Langone Medical Center
New York, New York, 10016
University of Utah Imaging and Neurosciences Center
Salt Lake City, Utah, 84108
University of California San Francisco
San Francisco, California, 94115
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
About this study
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.
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- iPad-Based Clinical Support Care, Standard Clinical Care
- Keywords
- Deep Brain Stimulation, DBS, STN, GPi, Globus pallidus, Subthalamic nucleus, Neuromodulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPad-Based Clinical Support CareDevice
Also called iPad-Based Tool
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.
Standard Clinical CareOther
Subjects in this treatment arm will receive DBS programming at regular intervals as part of routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| iPad-based Clinical Support Care | Active comparator | 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). Receives: Device: iPad-Based Clinical Support Care |
| Standard Clinical Care | Active comparator | 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). Receives: Other: Standard Clinical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
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).
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study startJul 2015
- Primary completion29 Apr 2020
- Study completion29 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Christopher Butson, University of Utah
- Investigators
- Christopher Butson, PhD, Principal investigator, University of Utah Scientific Computing and Imaging Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474459
- Sponsor's protocol ID
- IRB # 82859
- Other IDs
- R01NR014852
- Status last verified
- Jun 2020
- First submitted
- 14 Jun 2015
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duffley G, Lutz BJ, Szabo A, Wright A, Hess CW, Ramirez-Zamora A, Zeilman P, Chiu S, Foote KD, Okun MS, Butson CR. Home Health Management of Parkinson Disease Deep Brain Stimulation: A Randomized Clinical Trial. JAMA Neurol. 2021 Aug 1;78(8):972-981. doi: 10.1001/jamaneurol.2021.1910.
PubMed 34180949
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Decision Support System for Nurse Management of Neuromodulation Therapy
- ClinicalTrials.gov ID
- NCT02474459
- Acronym / sponsor ID
- IRB # 82859
- Conditions
- Parkinson's Disease
- Keywords
- Deep Brain Stimulation, DBS, STN, GPi, Globus pallidus, Subthalamic nucleus, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- 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
- Study start
- Jul 2015 (actual)
- Primary completion
- 29 Apr 2020 (actual)
- Study completion
- 29 Apr 2020 (actual)
- First posted
- 17 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iPad-based Clinical Support Care | Active comparator | Device: iPad-Based Clinical Support CareSubjects 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 | Active comparator | Other: Standard Clinical CareSubjects 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). |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Had a DBS device implanted at a non-participating site.
- Any previous DBS programming
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iPad-Based Clinical Support CareAlso: iPad-Based ToolSubjects 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. | Device | iPad-based Clinical Support Care |
| Standard Clinical CareSubjects in this treatment arm will receive DBS programming at regular intervals as part of routine clinical care. | Other | Standard Clinical Care |
Primary outcome
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.
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).
3 secondary outcomes
Differences in caregiver strain for DBS patients using the iPad-based clinical decision support tool
Time frame: 6 months
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
Differences in patient quality of life as measured by the Parkinson's Disease Questionnaire - 39 (PDQ-39).
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Derived from this study: PubMed 34180949Duffley G, Lutz BJ, Szabo A, Wright A, Hess CW, Ramirez-Zamora A, Zeilman P, Chiu S, Foote KD, Okun MS, Butson CR. Home Health Management of Parkinson Disease Deep Brain Stimulation: A Randomized Clinical Trial. JAMA Neurol. 2021 Aug 1;78(8):972-981. doi: 10.1001/jamaneurol.2021.1910.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Butson, PhD principal investigator
University of Utah Scientific Computing and Imaging Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iPad-Based Clinical Support Care and Standard Clinical Care in people with Parkinson's Disease, run by University of Utah at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Difference in deep brain stimulation (DBS) programming time. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02474459, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.