Clinical trial NCT02874274: Vaccination Uptake (VAX) in PD
Official title: Vaccination Uptake in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Corticobasal syndrome
Dementia with Lewy Bodies
Home Visit Program (HVP)
Multidimensional Caregiver Strain Index
Parkinson's Disease Dementia
Progressive Supranuclear Palsy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-08-22
Enrollment: 164
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a study to see whether participation in the Edmond J. Safra Interdisciplinary Home Visit Program for Advanced Parkinson's (HVP) increases the rate of age-appropriate vaccinations in people with advanced Parkinson's Disease (PD) and related disorders. This study will evaluate the impact of the HVP on the rate of common illnesses such as flu and pneumonia in patients with advanced PD and related disorders over the course of one year.

As there is currently no data available on the baseline rate of vaccinations in either homebound or less disabled PD populations, investigators will seek to establish the baseline rate of vaccinations, barriers to getting vaccinated, and baseline healthcare utilization in these populations by piloting (Phase 1) and then implementing (Phase 2) a survey via telephone interviews. Investigators will then test feasibility of offering influenza and pneumococcal vaccinations, as appropriate, to the homebound individuals in our HVP cohort (Phase 3), and will compare their pre- and post-intervention rates of both outpatient and acute healthcare utilization and self-reported illness.


Eligibility criteria: Inclusion Criteria:

Phase 1:

* Diagnosed with idiopathic Parkinson's disease (a chronic, slowly-progressive neurological disorder), or related disorders including Dementia with Lewy Bodies, Multiple System Atrophy, Progressive Supranuclear Palsy, or Corticobasal Syndrome.

Phase 2:

* Subjects will be those diagnosed with idiopathic Parkinson's disease (a chronic, slowly-progressive neurological disorder), or related disorders including Dementia with Lewy Bodies, Multiple System Atrophy, Progressive Supranuclear Palsy, or Corticobasal Syndrome.
* Each subject must either 1) be willing and able to provide verbal, informed consent for the study, and for whom capacity to consent will be assessed using the questions below, or 2) if unable to provide informed consent due to lack of capacity, a caregiver is able to provide informed consent and the subject provides assent to participation.

Phase 3:

* Diagnosed with idiopathic Parkinson's disease (a chronic, slowly-progressive neurological disorder), or related disorders including Dementia with Lewy Bodies, Multiple System Atrophy, Progressive Supranuclear Palsy, or Corticobasal Syndrome.
* Each subject must either 1) be willing and able to provide written, informed consent for the study, and for whom capacity to consent will be assessed using the questions below, or 2) if unable to provide informed consent due to lack of capacity, a caregiver is able to provide informed consent and the subject provides assent to participation.

Subjects have one or more of the following criteria:

* Fluctuation
* Multi-morbidity
* Mismanages medication
* Cognitive impairment
* High risk for re-hospitalization
* High risk for nursing facility admission
* Suspected elder abuse
* Recent history of increased falls in home
* Caregiver burnout suspected
* Ability to participate in the research study as deemed by the Principal Investigator.

Exclusion Criteria:

* Diagnosis of another neurodegenerative disease or other major central nervous system disorder.

Subjects with severe hearing impairment or speech dysfunction that would preclude pa -Subjects with active psychosis or exhibiting symptoms of a severe psychiatric disorder.

Primary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: 30 Minutes
measure: Hoehn and Yahr Scale (HY)
timeFrame: 30 Minutes
measure: Parkinson's Disease Questionnaire- Short Form (PDQ-8
timeFrame: 30 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Andrew Feigin, MD
role: PRINCIPAL_INVESTIGATOR
References: