Vaccine Acceptance in Pregnant Minority Women
6. mars 2015 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
121
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Georgia
-
Atlanta, Georgia, Forente stater, 30308
- Emory University Hospital Midtown
-
Atlanta, Georgia, Forente stater, 30303
- Grady Health System
-
Decatur, Georgia, Forente stater, 30033
- Dourron OB/Gyn Associates Clinic
-
Riverdale, Georgia, Forente stater, 30274
- New Millenium Obstetrics & Gynecology
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 50 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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.
|
|
Eksperimentell: 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 komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Influenza vaccination rates in pregnancy
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Tdap vaccination rates in pregnancy
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Saad B Omer, PhD, Emory University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juli 2012
Primær fullføring (Faktiske)
1. juli 2014
Studiet fullført (Faktiske)
1. juli 2014
Datoer for studieregistrering
Først innsendt
30. november 2012
Først innsendt som oppfylte QC-kriteriene
30. november 2012
Først lagt ut (Anslag)
4. desember 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
9. mars 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. mars 2015
Sist bekreftet
1. mars 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- IRB00057339
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .