An interventional study of Standard of Care and Home Visit Program (HVP) in Parkinson's Disease, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2020-01-10.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Supportive care
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 164 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Phase 1:
Phase 2:
Phase 3:
Subjects have one or more of the following criteria:
Exclusion Criteria:
Subjects with severe hearing impairment or speech dysfunction that would preclude pa -Subjects with active psychosis or exhibiting symptoms of a severe psychiatric disorder.
outpatient healthcare utilization and self-reported illness.
Behavioral: Standard of Care
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)
A rating scale used to follow the longitudinal course of Parkinson's disease
Time frame: 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.
Time frame: 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
Time frame: 30 Minutes
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
NYU Langone Health