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

This study is currently recruiting participants.
Verified June 2017 by New York University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT02874274
First Posted: August 22, 2016
Last Update Posted: June 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
New York University School of Medicine
  Purpose

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.


Condition Intervention
Parkinson's Disease Behavioral: Standard of Care Behavioral: Home Visit Program (HVP)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Vaccination Uptake in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 30 Minutes ]
    A rating scale used to follow the longitudinal course of Parkinson's disease

  • Hoehn and Yahr Scale (HY) [ Time Frame: 30 Minutes ]
    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.

  • Parkinson's Disease Questionnaire- Short Form (PDQ-8 [ Time Frame: 30 Minutes ]
    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


Estimated Enrollment: 60
Actual Study Start Date: September 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 100 Non-Homebound Subjects
outpatient healthcare utilization and self-reported illness.
Behavioral: Standard of Care
Active Comparator: 60 Homebound Subjects
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)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02874274


Contacts
Contact: Naomi Friede 646-501-4871 naomi.friede@nyumc.org

Locations
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Naomi Friede    646-501-4871    naomi.friede@nyumc.org   
Principal Investigator: Jori Fleisher, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Jori Fleisher, MD New York University School of Medicine
  More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02874274     History of Changes
Other Study ID Numbers: 16-01157
First Submitted: August 17, 2016
First Posted: August 22, 2016
Last Update Posted: June 22, 2017
Last Verified: June 2017

Keywords provided by New York University School of Medicine:
Corticobasal syndrome
Dementia with Lewy Bodies
Home Visit Program (HVP)
Multidimensional Caregiver Strain Index
Parkinson's Disease Dementia
Progressive Supranuclear Palsy

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs