Influenza and Text Messaging in Pregnancy
Primary Purpose
Pregnancy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
influenza and general health information
general health information
Sponsored by
About this trial
This is an interventional health services research trial for Pregnancy focused on measuring Pregnancy, Influenza Vaccination
Eligibility 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.
Sites / Locations
- Magee-Womens Hospital of UPMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
General health information
Influenza and general health information
Arm Description
Pregnant women receiving text messages containing general health messages without including information regarding the importance of the influenza vaccination
Pregnant women receiving text messages with influenza facts and the importance of the influenza vaccination, as well as general health messages Intervention: Text messages with influenza facts
Outcomes
Primary Outcome Measures
To assess the ability of direct communication and education to patients using modern technology (cellular text messaging) to enhance vaccine uptake.
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.
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.
Full Information
NCT ID
NCT01248520
First Posted
November 23, 2010
Last Updated
December 12, 2018
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT01248520
Brief Title
Influenza and Text Messaging in Pregnancy
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A randomized, controlled clinical trial to assess whether text messaging to an outpatient obstetric population can improve maternal influenza vaccine uptake.
Detailed Description
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. Despite the safety and efficacy of influenza vaccines, suboptimal maternal vaccination rates (13-24%) persist nationwide. Barriers to influenza vaccination during pregnancy include patient concerns about vaccine safety and unappreciated risk of influenza infection. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy
Keywords
Pregnancy, Influenza Vaccination
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
216 (Actual)
8. Arms, Groups, and Interventions
Arm Title
General health information
Arm Type
Placebo Comparator
Arm Description
Pregnant women receiving text messages containing general health messages without including information regarding the importance of the influenza vaccination
Arm Title
Influenza and general health information
Arm Type
Active Comparator
Arm Description
Pregnant women receiving text messages with influenza facts and the importance of the influenza vaccination, as well as general health messages Intervention: Text messages with influenza facts
Intervention Type
Other
Intervention Name(s)
influenza and general health information
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
general health information
Intervention Description
Subjects assigned to the influenza information group will receive health text messages from the time they enroll until they deliver.
Primary Outcome Measure Information:
Title
To assess the ability of direct communication and education to patients using modern technology (cellular text messaging) to enhance vaccine uptake.
Description
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.
Time Frame
at participant post-partum visit
Secondary Outcome Measure Information:
Title
To assess the ability of direct education via text messaging to enhance knowledge about influenza infection and vaccination in pregnancy.
Description
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.
Time Frame
at participant post-partum visit
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Moniz, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Magee-Womens Hospital of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23635672
Citation
Moniz MH, Hasley S, Meyn LA, Beigi RH. Improving influenza vaccination rates in pregnancy through text messaging: a randomized controlled trial. Obstet Gynecol. 2013 Apr;121(4):734-740. doi: 10.1097/AOG.0b013e31828642b1.
Results Reference
derived
Learn more about this trial
Influenza and Text Messaging in Pregnancy
We'll reach out to this number within 24 hrs