Vaccine Acceptance in Pregnant Minority Women
2015年3月6日 更新者: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.
研究概览
研究类型
介入性
注册 (实际的)
121
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Georgia
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Atlanta、Georgia、美国、30308
- Emory University Hospital Midtown
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Atlanta、Georgia、美国、30303
- Grady Health System
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Decatur、Georgia、美国、30033
- Dourron OB/Gyn Associates Clinic
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Riverdale、Georgia、美国、30274
- New Millenium Obstetrics & Gynecology
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 50年 (成人)
接受健康志愿者
是的
有资格学习的性别
女性
描述
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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 分配:随机化
- 介入模型:阶乘赋值
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的: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.
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实验性的: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.
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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.
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安慰剂比较: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.
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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.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Influenza vaccination rates in pregnancy
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Tdap vaccination rates in pregnancy
大体时间: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.
|
Baseline and one month after participant's expected date of delivery
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Change in attitudes regarding vaccination
大体时间:Baseline and one month after the expected date of delivery
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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.
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Baseline and one month after the expected date of delivery
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年7月1日
初级完成 (实际的)
2014年7月1日
研究完成 (实际的)
2014年7月1日
研究注册日期
首次提交
2012年11月30日
首先提交符合 QC 标准的
2012年11月30日
首次发布 (估计)
2012年12月4日
研究记录更新
最后更新发布 (估计)
2015年3月9日
上次提交的符合 QC 标准的更新
2015年3月6日
最后验证
2015年3月1日
更多信息
与本研究相关的术语
其他研究编号
- IRB00057339
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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