Vaccination Uptake (VAX) in PD (VAX-PD)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02874274|
Recruitment Status : Active, not recruiting
First Posted : August 22, 2016
Last Update Posted : August 27, 2018
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 or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Behavioral: Standard of Care Behavioral: Home Visit Program (HVP)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||164 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Vaccination Uptake in Parkinson's Disease|
|Actual Study Start Date :||September 2016|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2018|
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.
- 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
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
|United States, New York|
|New York University School of Medicine|
|New York, New York, United States, 10016|
|Principal Investigator:||Jori Fleisher, MD||New York University School of Medicine|