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Vaccination Uptake (VAX) in PD (VAX-PD)

NYU Langone Health logo

NYU Langone Health

Status

Completed

Conditions

Parkinson's Disease

Treatments

Behavioral: Standard of Care
Behavioral: Home Visit Program (HVP)

Study type

Interventional

Funder types

Other

Identifiers

NCT02874274
16-01157

Details and patient eligibility

About

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.

Enrollment

164 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

164 participants in 2 patient groups

100 Non-Homebound Subjects
Active Comparator group
Description:
outpatient healthcare utilization and self-reported illness.
Treatment:
Behavioral: Standard of Care
60 Homebound Subjects
Active Comparator group
Description:
Will test the feasibility of offering influenza and pneumococcal vaccinations, as appropriate, to the homebound individuals in our HVP cohort
Treatment:
Behavioral: Home Visit Program (HVP)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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