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Vaccine Social Media Randomized Intervention Trial (VSMRCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01873040
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : October 18, 2017
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Kaiser Permanente

Tracking Information
First Submitted Date  ICMJE June 5, 2013
First Posted Date  ICMJE June 7, 2013
Last Update Posted Date October 18, 2017
Study Start Date  ICMJE August 2013
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2016)
Days under-immunized [ Time Frame: 2 years ]
Days under-immunized is a metric to identify immunization delay. For each vaccine dose calculate the difference between when the vaccine dose was actually administered and when the vaccine dose should have been administered according to the Advisory Committee on Immunization Practices (ACIP) schedule. That difference is summed across all doses and vaccines for a total number of days under-immunized for each child. Total days under immunized was calculated 200 days after life or after enrollment. If someone had 0 days at that time they were considered "up to date".
Original Primary Outcome Measures  ICMJE
 (submitted: June 5, 2013)
Days under-immunized [ Time Frame: 2 years ]
Days under-immunized is a metric to identify immunization delay. For each vaccine dose calculate the difference between when the vaccine dose was actually administered and when the vaccine dose should have been administered according to the Advisory Committee on Immunization Practices (ACIP) schedule. That difference is summed across all doses and vaccines for a total number of days under-immunized for each child.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
Knowledge, Attitudes and Beliefs about immunizations [ Time Frame: Baseline, Child age 3-5 months, Child age 12-15 months ]
Knowledge, attitudes, and beliefs will be measured with a survey at up to 3 time points during the study: 1) Initial enrollment in the study, 2) child's ag=4-6 months and 3) child's age=11-13 months.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2013)
Knowledge, Attitudes and Beliefs about immunizations [ Time Frame: Baseline, Child age 4-6 months, Child age 11-13 months ]
Knowledge, attitudes, and beliefs will be measured with a survey at up to 3 time points during the study: 1) Initial enrollment in the study, 2) child's ag=4-6 months and 3) child's age=11-13 months.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vaccine Social Media Randomized Intervention Trial
Official Title  ICMJE Randomized Intervention Trial to Evaluate a Vaccine Social Media Website
Brief Summary

This study will assess the effectiveness of social media website devoted to vaccines to change immunization knowledge, perceptions and behavior. If effective, this intervention will represent an innovative, low cost and broadly applicable resource to reduce parental vaccination concerns.

The study has two hypothesis:

  1. Parents receiving usual care plus social media website will demonstrate higher early childhood immunization rates to parents receiving either usual plus non interactive website or usual care only.
  2. Parents receiving usual care plus social media website will demonstrate positive changes in knowledge, attitudes and beliefs supporting vaccination compared to parents receiving either usual care plus non-interactive website or usual care only.
Detailed Description Participants will be enrolled in the study, stratified based on hesitancy and randomly assigned to 1 of 3 study arms and followed for 1-2 years.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Communicable Diseases
Intervention  ICMJE
  • Behavioral: Social Media plus information pages
    Participants will receive access to the study vaccine website information pages and social media feature including blogs, discussion forums, expert chats, and ask an expert.
  • Behavioral: Vaccine Information Pages
    Participants will receive access to the study vaccine website information pages.
Study Arms  ICMJE
  • Experimental: Social media plus information pages
    Participants will have access to the vaccine social media website with information pages and social media features including discussion forums, blogs, chat with an expert, and ask an expert.
    Intervention: Behavioral: Social Media plus information pages
  • Experimental: Information Pages
    Participants will have website access to vaccine information pages.
    Intervention: Behavioral: Vaccine Information Pages
  • No Intervention: Usual Care
    Participants will not have access to the vaccine website. They will receive pediatric care as usual.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2016)
1675
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2013)
2000
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women >20 weeks Pregnant (including parents of children up to 1 year of age).
  • >18 years of age

Exclusion Criteria:

  • Non english speak
  • Do not intend to use Kaiser insurance for the child
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01873040
Other Study ID Numbers  ICMJE 1R01HS021492-01( U.S. AHRQ Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kaiser Permanente
Study Sponsor  ICMJE Kaiser Permanente
Collaborators  ICMJE Agency for Healthcare Research and Quality (AHRQ)
Investigators  ICMJE
Principal Investigator: Jason M Glanz, PhD Kaiser Permanente
PRS Account Kaiser Permanente
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP