Vaccination Uptake (VAX) in PD

NCT ID: NCT02874274

Last Updated: 2020-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-04-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

100 Non-Homebound Subjects

outpatient healthcare utilization and self-reported illness.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: BEHAVIORAL

60 Homebound Subjects

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

Group Type: ACTIVE_COMPARATOR

Home Visit Program (HVP)

Intervention Type: 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.

Interventions

Standard of Care

Intervention Type: BEHAVIORAL

Home Visit Program (HVP)

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Feigin, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

16-01157

Identifier Type: -

Identifier Source: org_study_id