Parkinson Disease
Conditions
Keywords
Home Health
Brief summary
The central hypothesis is that home health nurses can improve access and provide high quality care when guided by a sophisticated platform that integrates bioinformatics, patient-specific computational modeling, and continuous symptom measurement.
Interventions
OTHERNurse Telehealth
Subjects will receive nurse telehealth Mobile Decision Support System (MAP) DBS care
OTHERSTANDARD DBS
Subjects will receive standard in-person clinic-based DBS care administered without the use of Mobile Decision Support System (MAP) DBS
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Pre-operative Inclusion Criteria: A good response to levodopa is required in order to exclude patients with Parkinson's plus syndromes, and will be defined as a 30% improvement in parkinsonian motor signs based upon the Unified PD Rating Scale (UPDRS) motor examination subscore, following the administration of 1.5 times the typical dopaminergic dose during the screening neurological examination. Patients must also have PD for a minimum of 5 years duration. * Additional inclusion criteria consist of: 1) Hoehn & Yahr stage II or worse when off; 2) Intractable, disabling motor fluctuations and/or tremor; 3) Age between 30-75 years; 4) Unsatisfactory clinical response to maximal medical management (with trials of both higher and lower doses of antiparkinsonian drugs). 5) A stable/optimal medical regimen of antiparkinsonian drug therapy for at least one month prior to surgery; 6) access to high-speed internet in the home.
Exclusion criteria
* Clinically significant medical disease that would increase the risk of developing pre- or postoperative complications (e.g. significant cardiac or pulmonary disease, uncontrolled hypertension). * Evidence of secondary or atypical parkinsonism. * MRI scan with significant evidence of brain atrophy or other abnormalities. * Dementia as evidenced by impairment in two neuropsychological domains and impaired or borderline neuropsychological function in one additional domain. * A major untreated psychiatric disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of participant clinic visits | 6 MONTHS from date of enrollment | The number of in-person clinic visits required for each participant during the 6-month post operative DBS period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PDQ-39 Scores | 6-months | Difference in PDQ-39 scores from baseline to the 6-month time point. PDQ summary index score 0-very good to 100 bad |
Other
| Measure | Time frame | Description |
|---|---|---|
| UPDRS scores | 6-months | Difference in UPDRS scores from baseline to 6-month time point. UPDRS scoring scale 0-very good to 100-bad |
Outcome results
None listed