Vaccination Uptake (VAX) in PD

NCT02874274 | Completed

• 1 other identifier: 16-01157
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Unified Parkinson's Disease Rating Scale (UPDRS)

  A rating scale used to follow the longitudinal course of Parkinson's disease

  30 Minutes

• Hoehn and Yahr Scale (HY)

  A system used for describing how Parkinson's symptoms progress and the relative level of disability. There are five stages: Stage 0 - No signs of disease; Stage 1 - Unilateral disease; Stage 1.5 - Unilateral plus axial involvement; Stage 2 - Bilateral disease, without impairment of balance; Stage 2.5 - Mild bilateral disease with recovery on pull test; Stage 3 - Mild to moderate bilateral disease; some postural instability; physically independent; Stage 4 - Severe disability; still able to walk or stand unassisted; Stage 5 - Wheelchair bound or bedridden unless aided.

  30 Minutes

• Parkinson's Disease Questionnaire- Short Form (PDQ-8

  A validated, brief, 8-item measure of quality of life in PD with a summary index score standardized to a scale of 0-100, with higher scores signifying worse quality of life; this scale is recommended for use in PD by the Movement Disorder Society.10

  30 Minutes

Study Arms (2)

100 Non-Homebound Subjects

ACTIVE COMPARATOR

outpatient healthcare utilization and self-reported illness.

Behavioral: Standard of Care

60 Homebound Subjects

ACTIVE COMPARATOR

Will test the feasibility of offering influenza and pneumococcal vaccinations, as appropriate, to the homebound individuals in our HVP cohort

Behavioral: Home Visit Program (HVP)

Interventions

Standard of Care BEHAVIORAL

100 Non-Homebound Subjects

Home Visit Program (HVP) BEHAVIORAL

The study team will also contact the subject by phone within one week of each vaccination visit to assess for any adverse effects related to vaccination, included but not limited to: injection site pain, tenderness, swelling, pruritus, induration, or erythema; systemic symptoms such as fatigue, chills, headache, anorexia, malaise, myalgias, or anaphylaxis. Subjects will be contacted 90 days (+ 14 days) following Visit 3 to inquire about any additional symptoms and healthcare utilization.

60 Homebound Subjects

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Corticobasal Degeneration; Lewy Body Disease; Supranuclear Palsy, Progressive

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Tauopathies; Dementia; Neurocognitive Disorders; Mental Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Andrew Feigin, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 22, 2016
• Study Start: September 1, 2016
• Primary Completion: April 12, 2018
• Study Completion: April 12, 2018
• Last Updated: January 10, 2020

Record last verified: 2020-01

Locations

US (1)