Communicable DiseasesREDIVACNCT02665013
Reducing Delay of Vaccination in Children Study
A study testing Tailored and Untailored in people with Communicable Diseases, run by Kaiser Permanente at 1 site in United States.
Trial summary
This trial will assess the effectiveness of a tailored message intervention on decreasing infant undervaccination. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Communicable Diseases
- What is being tested?
- Tailored and Untailored
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 824 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to May 2019
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolled at Kaiser Permanente Colorado, Pregnant in the 3rd trimester, and plan to use Kaiser Permanente Colorado for the child's medical care received.
Who cannot join
- less then 18 years of age, non-english speaking and an inability to consent
Trial locations and contacts
1 site in 1 country.
About this study
This trial will assess the effectiveness of a tailored message intervention on decreasing infant undervaccination.
Read the detailed description
This intervention is based on the concept of "message tailoring," whereby each mother is provided with individually customized vaccine- related information that addresses their unique concerns, values, questions and logistical barriers. Message tailoring is an evidence-based health messaging strategy that has been shown to improve compliance with a wide variety of preventive health care behaviors among diverse patient populations.
In this three-armed trial the investigator will examine how providing mothers with multiple "doses" of a tailored versus untailored version of our intervention compares with "usual care" for the impact on infant under-vaccination. Secondary outcomes will include maternal vaccine-related attitudes (including level of vaccine hesitancy), alignment of maternal values with provider recommendations, and self-efficacy for overcoming logistical barriers to vaccination.
- Conditions
- Communicable Diseases
- Being tested
- Tailored, Untailored
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TailoredBehavioural
Pregnant women will be recruited to the study. The intervention will be delivered to participants prior to the child's 2 month well child visit, when the child is between 4 and 6 months of age, and when the child is 10-12 months of age. The first intervention occurs at enrollment in the study. Participants in the tailored intervention arm will receive vaccine information tailored specific to her concerns and values at each intervention point.
UntailoredBehavioural
Pregnant women will be recruited to the study. The intervention will be delivered to participants prior to the child's 2 month well child visit, when the child is between 4 and 6 months of age, and when the child is 10-12 months of age. The first intervention occurs at enrollment in the study. Participants in the untailored arm will receive vaccine information at each intervention time point, but it will not be tailored to her specific concerns.
| Study group | Role | What they receive |
|---|---|---|
| Tailored | Experimental | Participants will complete surveys at each intervention time point. Based on survey responses, they will receive vaccine information on the study website tailored to their vaccine concerns and values Receives: Behavioral: Tailored |
| Untailored | Placebo comparator | Participants will complete surveys at each intervention time point and receive vaccine information on the study website. The vaccine information will NOT be tailored to their concerns and values. Receives: Behavioral: Untailored |
| Usual Care | No intervention | Participants will complete surveys at each intervention time point. They will receive vaccine information sheets that are provided in the well child visits at enrollment in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The child's vaccination status
assessed using both a continuous and dichotomous measure. Continuous: measure of average days under-vaccinated is a recently developed metric measuring the average number of days a child is unvaccinated based on the vaccines given and the date when the vaccines where given. Dichotomous: mesauring the child's days undervaccinated or whether or not the child is up-to-date with no vaccination delays.
Measured: 200 days
Secondary outcomes (2)
Maternal Vaccine attitudes
Maternal vaccine attitudes are collected from survey items and include attitudes and beliefs about vaccines as well as level of vaccine hesitancy
Measured: 12 months
Maternal Vaccine values
Health values related to vaccines are measured from survey items and include conformity, security, power, self-direction, and universalism
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Communicable DiseasesStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Outcomes assessor
- Enrolment
- 824 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, University of Michigan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665013
- Sponsor's protocol ID
- 1R01HD079457-01
- Acronym
- REDIVAC
- Status last verified
- Apr 2019
- First submitted
- 4 Jan 2016
- Last updated
- 13 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Glanz JM, Wagner NM, Narwaney KJ, Pyrzanowski J, Kwan BM, Sevick C, Resnicow K, Dempsey AF. Web-Based Tailored Messaging to Increase Vaccination: A Randomized Clinical Trial. Pediatrics. 2020 Nov;146(5):e20200669. doi: 10.1542/peds.2020-0669. Epub 2020 Oct 12.
PubMed 33046584Dempsey AF, Wagner N, Narwaney K, Pyrzanowski J, Kwan BM, Kraus C, Gleason K, Resnicow K, Sevick C, Cataldi J, Brewer SE, Glanz JM. 'Reducing Delays In Vaccination' (REDIVAC) trial: a protocol for a randomised controlled trial of a web-based, individually tailored, educational intervention to improve timeliness of infant vaccination. BMJ Open. 2019 May 22;9(5):e027968. doi: 10.1136/bmjopen-2018-027968.
PubMed 31122997
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Delay of Vaccination in Children Study
- ClinicalTrials.gov ID
- NCT02665013
- Acronym / sponsor ID
- REDIVAC / 1R01HD079457-01
- Conditions
- Communicable Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 824 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, University of Michigan
- Study start
- Apr 2016 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 27 Jan 2016 (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.
This trial will assess the effectiveness of a tailored message intervention on decreasing infant undervaccination.
Detailed description
This intervention is based on the concept of "message tailoring," whereby each mother is provided with individually customized vaccine- related information that addresses their unique concerns, values, questions and logistical barriers. Message tailoring is an evidence-based health messaging strategy that has been shown to improve compliance with a wide variety of preventive health care behaviors among diverse patient populations.
In this three-armed trial the investigator will examine how providing mothers with multiple "doses" of a tailored versus untailored version of our intervention compares with "usual care" for the impact on infant under-vaccination. Secondary outcomes will include maternal vaccine-related attitudes (including level of vaccine hesitancy), alignment of maternal values with provider recommendations, and self-efficacy for overcoming logistical barriers to vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tailored | Experimental | Behavioral: TailoredParticipants will complete surveys at each intervention time point. Based on survey responses, they will receive vaccine information on the study website tailored to their vaccine concerns and values |
| Untailored | Placebo comparator | Behavioral: UntailoredParticipants will complete surveys at each intervention time point and receive vaccine information on the study website. The vaccine information will NOT be tailored to their concerns and values. |
| Usual Care | No intervention | –Participants will complete surveys at each intervention time point. They will receive vaccine information sheets that are provided in the well child visits at enrollment in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Enrolled at Kaiser Permanente Colorado, Pregnant in the 3rd trimester, and plan to use Kaiser Permanente Colorado for the child's medical care received.
Key exclusion criteria (1 listed)
- less then 18 years of age, non-english speaking and an inability to consent
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 |
|---|---|---|
| TailoredPregnant women will be recruited to the study. The intervention will be delivered to participants prior to the child's 2 month well child visit, when the child is between 4 and 6 months of age, and when the child is 10-12 months of age. The first intervention occurs at enrollment in the study. Participants in the tailored intervention arm will receive vaccine information tailored specific to her concerns and values at each intervention point. | Behavioural | Tailored |
| UntailoredPregnant women will be recruited to the study. The intervention will be delivered to participants prior to the child's 2 month well child visit, when the child is between 4 and 6 months of age, and when the child is 10-12 months of age. The first intervention occurs at enrollment in the study. Participants in the untailored arm will receive vaccine information at each intervention time point, but it will not be tailored to her specific concerns. | Behavioural | Untailored |
Primary outcome
The child's vaccination status
Time frame: 200 days
assessed using both a continuous and dichotomous measure. Continuous: measure of average days under-vaccinated is a recently developed metric measuring the average number of days a child is unvaccinated based on the vaccines given and the date when the vaccines where given. Dichotomous: mesauring the child's days undervaccinated or whether or not the child is up-to-date with no vaccination delays.
2 secondary outcomes
Maternal Vaccine attitudes
Time frame: 12 months
Maternal Vaccine values
Time frame: 12 months
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 13 Jun 2019.
- Derived from this study: PubMed 33046584Glanz JM, Wagner NM, Narwaney KJ, Pyrzanowski J, Kwan BM, Sevick C, Resnicow K, Dempsey AF. Web-Based Tailored Messaging to Increase Vaccination: A Randomized Clinical Trial. Pediatrics. 2020 Nov;146(5):e20200669. doi: 10.1542/peds.2020-0669. Epub 2020 Oct 12.
- Derived from this study: PubMed 31122997Dempsey AF, Wagner N, Narwaney K, Pyrzanowski J, Kwan BM, Kraus C, Gleason K, Resnicow K, Sevick C, Cataldi J, Brewer SE, Glanz JM. 'Reducing Delays In Vaccination' (REDIVAC) trial: a protocol for a randomised controlled trial of a web-based, individually tailored, educational intervention to improve timeliness of infant vaccination. BMJ Open. 2019 May 22;9(5):e027968. doi: 10.1136/bmjopen-2018-027968.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored and Untailored in people with Communicable Diseases, run by Kaiser Permanente 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 1 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 13 Jun 2019. 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. Some participants in this study may receive a placebo. 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?
The child's vaccination status (time frame: 200 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02665013, which also lists 2 linked publications.
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 13 Jun 2019.