- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01369394
Making Decisions About the Measles-Mumps-Rubella Vaccine
December 8, 2014 updated by: Amanda Dempsey, University of Michigan
Developing a Computer-based Intervention That Provides Individually-tailored Educational Information for MMR Vaccine-hesitant Parents
The goal of this study is to determine whether a computer-based intervention that delivers individually-tailored educational messages about the MMR vaccine increases MMR vaccine-hesitant parents' intentions to have their children vaccinated.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This will be a randomized controlled intervention trial for MMR vaccine-hesitant parents of children ages six years and younger who have not yet received the MMR vaccine.
Parents will complete a three-item measure that assesses their baseline intentions for having their children vaccinated with MMR.
Participants will then fill out a short, computer-based survey that assesses demographic factors, prior experience with MMR, and views about a variety of potential barriers to MMR vaccination.
Following the survey, the intervention group (40 parents) will view a series of tailored educational messages resembling web pages that uses their survey data to address at an individual level their specific concerns about the MMR vaccine.
The control group (40 parents) will view a series of generic educational messages resembling web pages that is similar in appearance to the intervention, but contains only untailored information about the vaccine.
After navigating through these educational messages, MMR vaccination intention will be reassessed using the same three-item measure as for the baseline assessment of vaccination intention.
The vaccine administration records of the children of these parents will be accessed after parents' participation in the study to assess whether the MMR vaccine was provided to the child.
Study Type
Interventional
Enrollment (Actual)
79
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- UMHS Outpatient Pediatrics
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Parent is greater than or equal to 18 years of age
- Parent has a child 6 years of age or younger
- When asked to describe how he/she feels about getting child vaccinated against MMR, parent responds "I don't want to get my child vaccinated" or "I'm unsure if I want my child to get vaccinated"
Exclusion Criteria:
- Cannot read/speak English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tailored information
Individuals assigned to the experimental group will receive individually-tailored educational messages.
|
Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions.
The computer-based tailoring system will generate educational messages based on participants' responses to survey questions.
The intervention group will receive tailored educational messages, whereas the control group will receive generic educational messages.
The tailored and generic educational messages will be presented as to look like web pages.
However, the messages will only exist on the study computer, and will not be linked to any "live" server or website.
|
Active Comparator: Untailored information
Individuals assigned to the control group will receive generic, untailored educational messages.
|
Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions.
The computer-based tailoring system will generate educational messages based on participants' responses to survey questions.
The intervention group will receive tailored educational messages, whereas the control group will receive generic educational messages.
The tailored and generic educational messages will be presented as to look like web pages.
However, the messages will only exist on the study computer, and will not be linked to any "live" server or website.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parent's intention to vaccinate child against MMR
Time Frame: Date of intervention (one day)
|
Parent will rate his/her intention to have child vaccinated against MMR using a Likert scale before and after the intervention.
|
Date of intervention (one day)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Use of the intervention
Time Frame: At the time of intervention participation
|
We will assess the number of pages viewed and time spend per page for each participant viewing the intervention.
|
At the time of intervention participation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amanda Dempsey, MD, PhD, MPH, Children's Outcomes Research Program
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
June 7, 2011
First Submitted That Met QC Criteria
June 7, 2011
First Posted (Estimate)
June 8, 2011
Study Record Updates
Last Update Posted (Estimate)
December 10, 2014
Last Update Submitted That Met QC Criteria
December 8, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Stomatognathic Diseases
- Mouth Diseases
- Morbillivirus Infections
- Paramyxoviridae Infections
- Mononegavirales Infections
- Salivary Gland Diseases
- Togaviridae Infections
- Rubivirus Infections
- Rubulavirus Infections
- Parotitis
- Parotid Diseases
- Measles
- Rubella
- Mumps
Other Study ID Numbers
- 186564
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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