MeaslesNCT01369394
Making Decisions About the Measles-Mumps-Rubella Vaccine
A study testing Behavioral: Computer-based tailoring system in people with Measles and Mumps, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Behavioral: Computer-based tailoring system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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"
Who cannot join
- Cannot read/speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
UMHS Outpatient Pediatrics
Ann Arbor, Michigan, 48109
About this study
Official title: 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.
Read the 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.
- Conditions
- Measles, Mumps, Rubella, MMR Vaccination
- Being tested
- Behavioral: Computer-based tailoring system
- Keywords
- Measles, Mumps, Rubella, MMR, Prevention, Tailoring, Persuasive communication, Children
- Medical subject headings
- Measles, Mumps, Rubella
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: Computer-based tailoring systemOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Tailored information | Experimental | Individuals assigned to the experimental group will receive individually-tailored educational messages. Receives: Other: Behavioral: Computer-based tailoring system |
| Untailored information | Active comparator | Individuals assigned to the control group will receive generic, untailored educational messages. Receives: Other: Behavioral: Computer-based tailoring system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent's intention to vaccinate child against MMR
Parent will rate his/her intention to have child vaccinated against MMR using a Likert scale before and after the intervention.
Measured: Date of intervention (one day)
Secondary outcomes (1)
Use of the intervention
We will assess the number of pages viewed and time spend per page for each participant viewing the intervention.
Measured: At the time of intervention participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeaslesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda Dempsey, University of Colorado, Denver
- Investigators
- Amanda Dempsey, MD, PhD, MPH, Principal investigator, Children's Outcomes Research Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369394
- Sponsor's protocol ID
- 186564
- Status last verified
- Dec 2014
- First submitted
- 7 Jun 2011
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Computer-based Intervention That Provides Individually-tailored Educational Information for MMR Vaccine-hesitant Parents
- ClinicalTrials.gov ID
- NCT01369394
- Acronym / sponsor ID
- 186564
- Conditions
- Measles, Mumps, Rubella, MMR Vaccination
- Keywords
- Measles, Mumps, Rubella, MMR, Prevention, Tailoring, Persuasive communication, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 8 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored information | Experimental | Other: Behavioral: Computer-based tailoring systemIndividuals assigned to the experimental group will receive individually-tailored educational messages. |
| Untailored information | Active comparator | Other: Behavioral: Computer-based tailoring systemIndividuals assigned to the control group will receive generic, untailored educational messages. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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"
Key exclusion criteria (1 listed)
- Cannot read/speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral: Computer-based tailoring systemBoth 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. | Other | Tailored information, Untailored information |
Primary outcome
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.
1 secondary outcome
Use of the intervention
Time frame: At the time of intervention participation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Dempsey, MD, PhD, MPH principal investigator
Children's Outcomes Research Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: Computer-based tailoring system in people with Measles and Mumps, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent's intention to vaccinate child against MMR (time frame: Date of intervention (one day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2014.