NCT04677621

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable parkinson-disease

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 21, 2020

Completed
2 years until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

June 8, 2023

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

December 17, 2020

Last Update Submit

June 7, 2023

Conditions

Parkinson Disease

Keywords

Home Health

Outcome Measures

Primary Outcomes (1)

  • The number of participant clinic visits

    The number of in-person clinic visits required for each participant during the 6-month post operative DBS period.

    6 MONTHS from date of enrollment

Secondary Outcomes (1)

  • PDQ-39 Scores

    6-months

Other Outcomes (1)

  • UPDRS scores

    6-months

Study Arms (2)

Nurse Telehealth Intervention

EXPERIMENTAL

Allocated to tele-intervention

Other: Nurse Telehealth

Standard Deep Brain Stimulation (DBS)

ACTIVE COMPARATOR

Allocated to conventional approach

Other: STANDARD DBS

Interventions

Nurse TelehealthOTHER

Subjects will receive nurse telehealth Mobile Decision Support System (MAP) DBS care

Nurse Telehealth Intervention
STANDARD DBSOTHER

Subjects will receive standard in-person clinic-based DBS care administered without the use of Mobile Decision Support System (MAP) DBS

Standard Deep Brain Stimulation (DBS)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Michael Okun, MD

    University of Florida

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2020

First Posted

December 21, 2020

Study Start

January 1, 2023

Primary Completion

May 15, 2023

Study Completion

May 15, 2023

Last Updated

June 8, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share