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Influenza and Text Messaging in Pregnancy
This study has been completed.
Sponsor:
University of Pittsburgh
Information provided by (Responsible Party):
Richard Beigi, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01248520
First received: November 23, 2010
Last updated: April 15, 2015
Last verified: April 2015
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Purpose
History and the 2009 H1N1 influenza pandemic suggest that both seasonal and pandemic influenza infections impart disproportionate morbidity and mortality among gravidas. The influenza vaccine represents a viable, preventive health intervention to mitigate disease burden for gravidas and their neonates[1,2]. Despite the safety and efficacy of influenza vaccines, suboptimal maternal vaccination rates (13-24%) persist nationwide[3]. Barriers to influenza vaccination during pregnancy include patient concerns about vaccine safety and unappreciated risk of influenza infection[4]. Cellular phone text messaging has emerged as an innovative technology with advantages of ubiquity, rapid, confidential information transmission, and low cost. Text messaging may represent an effective way to educate pregnant women about their particular vulnerability to influenza infection and enhance influenza vaccine uptake. We propose a randomized, controlled clinical trial to assess whether text messaging to an outpatient obstetric population can improve maternal influenza vaccine uptake.
| Condition | Intervention |
|---|---|
| Influenza Vaccination | Other: influenza vaccination/general health/pregnancy information Other: general health/pregnancy information |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Participant) Primary Purpose: Health Services Research |
| Official Title: | Text Messaging For Preventative Health During Pregnancy; Improving Influenza Vaccination Rates In Pregnancy: A Randomized Controlled Trial of Text Messaging to Increase Vaccine Uptake |
Resource links provided by NLM:
Further study details as provided by Richard Beigi, University of Pittsburgh:
Primary Outcome Measures:
- To assess the ability of direct communication and education to patients using modern technology (cellular text messaging) to enhance vaccine uptake. [ Time Frame: at participant post-partum visit ]To assess the ability of direct communication and education to patients using modern technology (cellular text messaging) to enhance vaccine uptake. We hypothesize that text messaging will improve the timing (earlier in flu season) and rate of receipt of influenza vaccination in pregnancy.
Secondary Outcome Measures:
- To assess the ability of direct education via text messaging to enhance knowledge about influenza infection and vaccination in pregnancy. [ Time Frame: at participant post-partum visit ]To assess the ability of direct education via text messaging to enhance knowledge about influenza infection and vaccination in pregnancy. We hypothesize that women receiving text messages will be more likely than controls to have accurate knowledge about pregnant women's increased susceptibility to influenza and about the vaccine's safety and efficacy in pregnancy.
| Enrollment: | 216 |
| Study Start Date: | September 2010 |
| Study Completion Date: | April 2014 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: text messages without influenza information
Pregnant women will receive text messages containing health messages without including information regarding the importance of the influenza vaccination
|
Other: general health/pregnancy information
Subjects assigned to the influenza information group will receive health text messages from the time they enroll until they deliver.
|
|
Active Comparator: text messages with influenza information
Pregnant women will receive text messages containing health messages including information about the importance of the influenza vaccination
|
Other: influenza vaccination/general health/pregnancy information
Subjects assigned to the influenza information group will receive health text messages from the time they enroll until they deliver. These messages will contain general health information as well as information regarding influenza and the importance of vaccination during pregnancy.
|
Eligibility| Ages Eligible for Study: | 14 Years to 50 Years (Child, Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Pregnant women less than 28 weeks estimated gestation age
- Between 14-50 years of age
- Willing to provide informed consent and undergo necessary study procedures
Exclusion Criteria:
- Unwillingness or inability to receive text messages
- Receipt of the current season's influenza vaccine or plan to receive the influenza vaccine on the day of the enrollment visit
- Reported history of adverse reaction precluding receipt of the vaccine
- Unwillingness or inability to provide informed consent and comply with study criteria.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01248520
Please refer to this study by its ClinicalTrials.gov identifier: NCT01248520
Locations
| United States, Pennsylvania | |
| Magee-Womens Hospital of UPMC | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
Sponsors and Collaborators
University of Pittsburgh
Investigators
| Principal Investigator: | Michelle Moniz, MD | University of Pittsburgh |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Richard Beigi, Associate Professor, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT01248520 History of Changes |
| Other Study ID Numbers: |
PRO09100504 |
| Study First Received: | November 23, 2010 |
| Last Updated: | April 15, 2015 |
Keywords provided by Richard Beigi, University of Pittsburgh:
|
Pregnancy Influenza Vaccination |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections |
Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 28, 2017