Vaccine Acceptance in Pregnant Minority Women
6 maart 2015 bijgewerkt door: Saad B. Omer, PhD, Emory University
The purpose of study will be to test two vaccine education strategies to learn how they impact flu and pertussis (Tdap) vaccination rates and attitudes regarding vaccination during pregnancy after participating in the intervention.
The education strategies will be based on the elaboration likelihood model (ELM).
This model is based on experimental psychology and has been previously used to increase breast cancer screening rates.
These education strategies will be delivered through routine prenatal care visits to black/African-American women in Atlanta.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
121
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30308
- Emory University Hospital Midtown
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Atlanta, Georgia, Verenigde Staten, 30303
- Grady Health System
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Decatur, Georgia, Verenigde Staten, 30033
- Dourron OB/Gyn Associates Clinic
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Riverdale, Georgia, Verenigde Staten, 30274
- New Millenium Obstetrics & Gynecology
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 50 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
Inclusion Criteria:
- Pregnant, expecting delivery between August 31, 2012 and June 30, 2013
- Between the ages of 18-50 years old
- Black/African American
Exclusion Criteria:
- Have received the influenza or Tdap vaccine during the current pregnancy
- Already enrolled in the study
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: High Elaboration Video Arm
Women randomized to this arm will be exposed to a handheld/electronic tablet device-based video with detailed vaccine-related information designed to invoke a high level of attention to the message and thought (elaboration) while processing information.
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It is assumed that the women will also receive vaccine education materials from the OB/GYN practices as part of routine care.
The intervention for all three arms will be conducted during routine prenatal office visits.
Participants will complete a baseline questionnaire to assess attitudes regarding vaccination and will then be randomized to one of three enrollment arms and will be exposed to an intervention designed to take no longer than 20 minutes, so that patients can complete it during the time they are waiting to be seen.
While participants are completing the handheld/electronic tablet device-based intervention, the study recruiter will observe them and document dose exposure to the messages being presented.
The enrolled women will be contacted a month after the expected date of delivery and a follow up interview will be conducted to ascertain their vaccination status for receipt of influenza vaccine in pregnancy and Tdap during pregnancy or immediately post-partum.
|
|
Experimenteel: High Elaboration Interactive Tutorial Arm
Women will be exposed to a handheld/electronic tablet device-based intervention designed to invoke a high level of attention to the message and thought (elaboration) while processing information through an interactive question/answer format.
|
It is assumed that the women will also receive vaccine education materials from the OB/GYN practices as part of routine care.
The intervention for all three arms will be conducted during routine prenatal office visits.
Participants will complete a baseline questionnaire to assess attitudes regarding vaccination and will then be randomized to one of three enrollment arms and will be exposed to an intervention designed to take no longer than 20 minutes, so that patients can complete it during the time they are waiting to be seen.
While participants are completing the handheld/electronic tablet device-based intervention, the study recruiter will observe them and document dose exposure to the messages being presented.
The enrolled women will be contacted a month after the expected date of delivery and a follow up interview will be conducted to ascertain their vaccination status for receipt of influenza vaccine in pregnancy and Tdap during pregnancy or immediately post-partum.
|
|
Placebo-vergelijker: Low Elaboration / Control Arm
Women randomized to the control arm will be provided standard CDC vaccine information statements that will likely lead to low elaboration information processing.
|
It is assumed that the women will also receive vaccine education materials from the OB/GYN practices as part of routine care.
The intervention for all three arms will be conducted during routine prenatal office visits.
Participants will complete a baseline questionnaire to assess attitudes regarding vaccination and will then be randomized to one of three enrollment arms and will be exposed to an intervention designed to take no longer than 20 minutes, so that patients can complete it during the time they are waiting to be seen.
While participants are completing the handheld/electronic tablet device-based intervention, the study recruiter will observe them and document dose exposure to the messages being presented.
The enrolled women will be contacted a month after the expected date of delivery and a follow up interview will be conducted to ascertain their vaccination status for receipt of influenza vaccine in pregnancy and Tdap during pregnancy or immediately post-partum.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Influenza vaccination rates in pregnancy
Tijdsspanne: Baseline and one month after participant's expected date of delivery
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Data on vaccination status will be collected from participants enrolled in the main phase of the study during follow up starting one month after the expected date of delivery.
We will contact healthcare providers to obtain vaccination records for those who provide written consent to release their immunization records.
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Baseline and one month after participant's expected date of delivery
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Tdap vaccination rates in pregnancy
Tijdsspanne: Baseline and one month after participant's expected date of delivery
|
Data on vaccination status will be collected from participants enrolled in the main phase of the study during follow up starting one month after the expected date of delivery.
We will contact healthcare providers to obtain vaccination records for those who provide written consent to release their immunization records.
|
Baseline and one month after participant's expected date of delivery
|
|
Change in attitudes regarding vaccination
Tijdsspanne: Baseline and one month after the expected date of delivery
|
Data on attitudes regarding vaccination status will be collected from participants enrolled in the main phase of the study during follow up starting one month after the expected date of delivery.
|
Baseline and one month after the expected date of delivery
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Saad B Omer, PhD, Emory University
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Gust D, Brown C, Sheedy K, Hibbs B, Weaver D, Nowak G. Immunization attitudes and beliefs among parents: beyond a dichotomous perspective. Am J Health Behav. 2005 Jan-Feb;29(1):81-92. doi: 10.5993/ajhb.29.1.7.
- Gust DA, Kennedy A, Wolfe S, Sheedy K, Nguyen C, Campbell S. Developing tailored immunization materials for concerned mothers. Health Educ Res. 2008 Jun;23(3):499-511. doi: 10.1093/her/cym065. Epub 2007 Oct 23.
- Paulussen TG, Hoekstra F, Lanting CI, Buijs GB, Hirasing RA. Determinants of Dutch parents' decisions to vaccinate their child. Vaccine. 2006 Jan 30;24(5):644-51. doi: 10.1016/j.vaccine.2005.08.053. Epub 2005 Aug 26.
- Wilson BJ. Designing media messages about health and nutrition: what strategies are most effective? J Nutr Educ Behav. 2007 Mar-Apr;39(2 Suppl):S13-9. doi: 10.1016/j.jneb.2006.09.001.
- Baxter CE, Barata PC. The paradox of HPV vaccines: how to reach sexually inexperienced women for protection against a sexually transmitted infection. Womens Health Issues. 2011 May-Jun;21(3):239-45. doi: 10.1016/j.whi.2010.11.007. Epub 2011 Feb 18.
- Petty R, Cacioppo J. Communication and Persuasion: Central and Peripheral Routes to Attitude Change. New York, NY: Springer-Verlag; 1986.
- Vannice KS, Salmon DA, Shui I, Omer SB, Kissner J, Edwards KM, Sparks R, Dekker CL, Klein NP, Gust DA. Attitudes and beliefs of parents concerned about vaccines: impact of timing of immunization information. Pediatrics. 2011 May;127 Suppl 1(Suppl 1):S120-6. doi: 10.1542/peds.2010-1722R. Epub 2011 Apr 18.
- Kriss JL, Frew PM, Cortes M, Malik FA, Chamberlain AT, Seib K, Flowers L, Ault KA, Howards PP, Orenstein WA, Omer SB. Evaluation of two vaccine education interventions to improve pertussis vaccination among pregnant African American women: A randomized controlled trial. Vaccine. 2017 Mar 13;35(11):1551-1558. doi: 10.1016/j.vaccine.2017.01.037. Epub 2017 Feb 16.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juli 2012
Primaire voltooiing (Werkelijk)
1 juli 2014
Studie voltooiing (Werkelijk)
1 juli 2014
Studieregistratiedata
Eerst ingediend
30 november 2012
Eerst ingediend dat voldeed aan de QC-criteria
30 november 2012
Eerst geplaatst (Schatting)
4 december 2012
Updates van studierecords
Laatste update geplaatst (Schatting)
9 maart 2015
Laatste update ingediend die voldeed aan QC-criteria
6 maart 2015
Laatst geverifieerd
1 maart 2015
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- IRB00057339
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