Communicable DiseaseREDIVAC-LBNCT03516682
Reducing Delay in Vaccination of Children: Logistic Barriers
A study testing Reminders in people with Communicable Disease, run by Kaiser Permanente at 1 site in United States.
Trial summary
This study will assess the impact of automated reminders for the 6 month and 12 month vaccine visits to increase vaccination in parents experiencing logistic barriers to vaccination. Read more about this study
- Who is it for?
- Ages 1 month to 11 months
- Conditions the study is for
- Communicable Disease
- What is being tested?
- Reminders
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 31 Mar 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 1 month to 11 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents of children less than 11 months of age
- Currently enrolled at Kaiser Permanente Colorado at the time of identification
- The child is missing recommended vaccinations
Who cannot join
- Non-english speaking
- diagnosis code indicating parent vaccine refusal
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Colorado Institute for Health Research
Denver, Colorado, 80231
About this study
Official title: The REDIVAC Study-Reducing Delay in Vaccination of Children Study
This study will assess the impact of automated reminders for the 6 month and 12 month vaccine visits to increase vaccination in parents experiencing logistic barriers to vaccination.
Read the detailed description
Parents of children less than 11 months of age will be identified as delayed or missing vaccinations due to logistic barriers in the Kaiser Permanente Colorado population. Parents identified will be randomized to the intervention arm or the usual care arm. Those in the intervention arm will receive automated reminders for the 6 month and 12 month vaccine visits. Reminders will include scheduling information as well as access to a website with vaccine and scheduling information. They will also have an opportunity to provide preferences in how they receive the automated reminders (text, phone or email). There will be 2 reminders before the 6 and 12 month visits and 2 after the 6 and 12 month visits. Parents will be excluded from receiving reminders if they have received vaccines within the time frame when they are eligible to receive another vaccine or have a well child visit scheduled.
- Conditions
- Communicable Disease
- Being tested
- Reminders
- Keywords
- Logistic Barriers to Vaccination
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemindersBehavioural
Also called REDIVAC-Logistic Barriers
Automated reminders for the 6 month and 12 month vaccine visits for parents experiencing logistic barriers to vaccination.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Parents will receive usual care for their child at Kaiser Permanente Colorado. This includes recommendations for well child visits at 2, 4, 6 and 12 months of age as well as automated reminders for age eligible children to receive the flu shot during flu season. |
| Reminders | Experimental | Parents randomized to the reminder arm will receive automated reminders to complete a 6 month and 12 month vaccine visit for their child. They will receive 2 reminders before the child is 6 and 12 months of age and 2 reminders after their child is 6 and 12 months of age. Reminders will not occur if they have received vaccines within the eligible time frame to receive a vaccine or have a visit scheduled. After randomization, participants in the intervention arm will have an opportunity to provide their preference on how they receive reminders (text, phone and/or email). Participants not providing a preference will receive text reminders. If a child is randomized into the study after the child is 7 months of age, the parent will only be eligible for reminders for the 12 month vaccine visit. Receives: Behavioral: Reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccines received (Electronic Health Record)
Vaccination records from the participants electronic health record will be used to measure vaccines received. Vaccines received is a dichotomous variable indicating if any vaccines were received while enrolled in the study
Measured: up to a year of follow up
Secondary outcomes (1)
Vaccine dose (Electronic Health Record)
Vaccination records from the participants electronic health record will be used to measure vaccine dose. Vaccine dose is a measure of the vaccine doses that the child could have received while enrolled in the study, the number of vaccine doses received
Measured: up to a year of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start1 Jun 2018
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Communicable DiseaseStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver
- Responsible party
- Sponsor
- Investigators
- Jason Glanz, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516682
- Sponsor's protocol ID
- 1R01HD079457
- Acronym
- REDIVAC-LB
- Status last verified
- Aug 2018
- First submitted
- 26 Mar 2018
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
PubMed 32813276
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The REDIVAC Study-Reducing Delay in Vaccination of Children Study
- ClinicalTrials.gov ID
- NCT03516682
- Acronym / sponsor ID
- REDIVAC-LB / 1R01HD079457
- Conditions
- Communicable Disease
- Keywords
- Logistic Barriers to Vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- University of Colorado, Denver
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 4 May 2018 (actual)
- 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 study will assess the impact of automated reminders for the 6 month and 12 month vaccine visits to increase vaccination in parents experiencing logistic barriers to vaccination.
Detailed description
Parents of children less than 11 months of age will be identified as delayed or missing vaccinations due to logistic barriers in the Kaiser Permanente Colorado population. Parents identified will be randomized to the intervention arm or the usual care arm. Those in the intervention arm will receive automated reminders for the 6 month and 12 month vaccine visits. Reminders will include scheduling information as well as access to a website with vaccine and scheduling information. They will also have an opportunity to provide preferences in how they receive the automated reminders (text, phone or email). There will be 2 reminders before the 6 and 12 month visits and 2 after the 6 and 12 month visits. Parents will be excluded from receiving reminders if they have received vaccines within the time frame when they are eligible to receive another vaccine or have a well child visit scheduled.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Parents will receive usual care for their child at Kaiser Permanente Colorado. This includes recommendations for well child visits at 2, 4, 6 and 12 months of age as well as automated reminders for age eligible children to receive the flu shot during flu season. |
| Reminders | Experimental | Behavioral: RemindersParents randomized to the reminder arm will receive automated reminders to complete a 6 month and 12 month vaccine visit for their child. They will receive 2 reminders before the child is 6 and 12 months of age and 2 reminders after their child is 6 and 12 months of age. Reminders will not occur if they have received vaccines within the eligible time frame to receive a vaccine or have a visit scheduled. After randomization, participants in the intervention arm will have an opportunity to provide their preference on how they receive reminders (text, phone and/or email). Participants not providing a preference will receive text reminders. If a child is randomized into the study after the child is 7 months of age, the parent will only be eligible for reminders for the 12 month vaccine visit. |
Who may qualify
- Ages
- 1 month to 11 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Parents of children less than 11 months of age
- Currently enrolled at Kaiser Permanente Colorado at the time of identification
- The child is missing recommended vaccinations
Key exclusion criteria (2 listed)
- Non-english speaking
- diagnosis code indicating parent vaccine refusal
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 |
|---|---|---|
| RemindersAlso: REDIVAC-Logistic BarriersAutomated reminders for the 6 month and 12 month vaccine visits for parents experiencing logistic barriers to vaccination. | Behavioural | Reminders |
Primary outcome
Vaccines received (Electronic Health Record)
Time frame: up to a year of follow up
Vaccination records from the participants electronic health record will be used to measure vaccines received. Vaccines received is a dichotomous variable indicating if any vaccines were received while enrolled in the study
1 secondary outcome
Vaccine dose (Electronic Health Record)
Time frame: up to a year of follow up
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 7 Aug 2019.
- Derived from this study: PubMed 32813276Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
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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.
Jason Glanz, PhD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reminders in people with Communicable Disease, 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 3 inclusion and 2 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 7 Aug 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. 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?
Vaccines received (Electronic Health Record) (time frame: up to a year of follow up). 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 NCT03516682, which also lists 1 linked publication.
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 7 Aug 2019.