- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01483378
Increasing Use of the Vaccine Against Herpes Zoster/Shingles at NYULMC and Bellevue Hospital
August 7, 2013 updated by: NYU Langone Health
The purpose of this study is to determine if vaccination rate of eligible patients at a major urban public hospital will increase by having ophthalmologists screen patients for eligibility and a nurse administer the vaccine in the General Eye Clinic.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patient vaccination behaviors will be assessed after 100 doses of the Zostavax vaccine are provided to underserved patients screened by ophthalmologists at the General Eye Clinic at a public hospital that does not normally provide the vaccine.
A nurse will be at the clinic to administer the vaccine.
Patients will be contacted by phone 1 month later and seen within 3 months in the Eye Clinic to determine whether there were any side effects.
Study Type
Interventional
Enrollment (Actual)
170
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
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New York, New York, United States, 10016
- Bellevue Hospital
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New York, New York, United States, 10016
- NYU Langone Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 60 years of age or older
- Absence of evidence of immune compromise in the medical record
- Ability to speak and read English, Spanish or Chinese and give informed consent
Exclusion Criteria:
- Vulnerable patients, including the cognitively impaired, prisoners and employee
- FDA contraindications for Zostavax vaccine
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Subjects who received the vaccine
Patients in this arm were eligible for the herpes zoster vaccine and chose to receive it.
|
|
NO_INTERVENTION: Subjects who declined the vaccine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Answers to Survey Questions
Time Frame: January 9, 2012 to February 12, 2012
|
All enrolled patients completed a survey of baseline characteristics, eligibility for the herpes zoster vaccine, and attitudes regarding herpes zoster vaccination.
The survey results from patients who agreed to receive the herpes zoster vaccine were compared to the results of patients who declined to be vaccinated.
|
January 9, 2012 to February 12, 2012
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hurley LP, Lindley MC, Harpaz R, Stokley S, Daley MF, Crane LA, Dong F, Beaty BL, Tan L, Babbel C, Dickinson LM, Kempe A. Barriers to the use of herpes zoster vaccine. Ann Intern Med. 2010 May 4;152(9):555-60. doi: 10.7326/0003-4819-152-9-201005040-00005.
- Ghaznawi N, Virdi A, Dayan A, Hammersmith KM, Rapuano CJ, Laibson PR, Cohen EJ. Herpes zoster ophthalmicus: comparison of disease in patients 60 years and older versus younger than 60 years. Ophthalmology. 2011 Nov;118(11):2242-50. doi: 10.1016/j.ophtha.2011.04.002. Epub 2011 Jul 23.
- Hu AY, Strauss EC, Holland GN, Chan MF, Yu F, Margolis TP. Late varicella-zoster virus dendriform keratitis in patients with histories of herpes zoster ophthalmicus. Am J Ophthalmol. 2010 Feb;149(2):214-220.e3. doi: 10.1016/j.ajo.2009.08.030. Epub 2009 Nov 11.
- Lu PJ, Euler GL, Harpaz R. Herpes zoster vaccination among adults aged 60 years and older, in the U.S., 2008. Am J Prev Med. 2011 Feb;40(2):e1-6. doi: 10.1016/j.amepre.2010.10.012.
- Oxman MN, Levin MJ, Johnson GR, Schmader KE, Straus SE, Gelb LD, Arbeit RD, Simberkoff MS, Gershon AA, Davis LE, Weinberg A, Boardman KD, Williams HM, Zhang JH, Peduzzi PN, Beisel CE, Morrison VA, Guatelli JC, Brooks PA, Kauffman CA, Pachucki CT, Neuzil KM, Betts RF, Wright PF, Griffin MR, Brunell P, Soto NE, Marques AR, Keay SK, Goodman RP, Cotton DJ, Gnann JW Jr, Loutit J, Holodniy M, Keitel WA, Crawford GE, Yeh SS, Lobo Z, Toney JF, Greenberg RN, Keller PM, Harbecke R, Hayward AR, Irwin MR, Kyriakides TC, Chan CY, Chan IS, Wang WW, Annunziato PW, Silber JL; Shingles Prevention Study Group. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. N Engl J Med. 2005 Jun 2;352(22):2271-84. doi: 10.1056/NEJMoa051016.
- Rimland D, Moanna A. Increasing incidence of herpes zoster among Veterans. Clin Infect Dis. 2010 Apr 1;50(7):1000-5. doi: 10.1086/651078.
- Kaufman HE (ed) Herpes zoster ophthalmicus: preventing ocular complications through vaccination. Ophthalmology 2008; 115:S1-38
- Jung JJ, Elkin ZP, Li X, Goldberg JD, Edell AR, Cohen MN, Chen KC, Perskin MH, Park L, Cohen EJ. Increasing use of the vaccine against zoster through recommendation and administration by ophthalmologists at a city hospital. Am J Ophthalmol. 2013 May;155(5):787-95. doi: 10.1016/j.ajo.2012.11.022. Epub 2013 Feb 6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (ACTUAL)
February 1, 2012
Study Completion (ACTUAL)
February 1, 2012
Study Registration Dates
First Submitted
November 18, 2011
First Submitted That Met QC Criteria
November 30, 2011
First Posted (ESTIMATE)
December 1, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
August 9, 2013
Last Update Submitted That Met QC Criteria
August 7, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-02029
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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