COVID-19 VaccinesAIMED COVIDNCT05571657
COVID-19 Booster Dose Reminder/Recall for Adolescents
A study testing Reminder/Recall Sent Via Preferred Method of Communication in people with COVID-19 Vaccines, run by Marshfield Clinic Research Foundation at 1 site in United States.
Trial summary
A single COVID-19 booster dose has been recommended in the United States for adolescents aged ≥12 years to enhance protection against SARS-CoV-2 infection. This study will assess the efficacy of a one-time reminder/recall for COVID-19 booster dose among eligible adolescents in a regional healthcare system. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- COVID-19 Vaccines
- What is being tested?
- Reminder/Recall Sent Via Preferred Method of Communication
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,304 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2022to 31 Dec 2022
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Marshfield Clinic Health System patient aged 12-17 years with at least one preventive visit or two evaluation \& management visits with a Marshfield Clinic Health System provider in the last 36 months
- Due for a COVID-19 booster dose (completed the COVID-19 primary series and it has been ≥5 months since their second dose)
Who cannot join
- Primary care provider is not affiliated with Marshfield Clinic Health System
- Opted out of Marshfield Clinic Health System centralized vaccine reminder notifications
- Received COVID-19 vaccine off label
- Missing or invalid contact information
- Deceased
Trial locations and contacts
1 site in 1 country.
United States1 site
Marshfield Clinic Health System
Marshfield, Wisconsin, 54449
About this study
Official title: Understanding and Addressing the Disparity in Vaccination Coverage Among U.S. Adolescents Living in Rural Versus Urban Areas
A single COVID-19 booster dose has been recommended in the United States for adolescents aged ≥12 years to enhance protection against SARS-CoV-2 infection. This study will assess the efficacy of a one-time reminder/recall for COVID-19 booster dose among eligible adolescents in a regional healthcare system.
- Conditions
- COVID-19 Vaccines
- Being tested
- Reminder/Recall Sent Via Preferred Method of Communication
- Keywords
- reminder/recall, COVID-19, intervention, adolescents
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reminder/Recall Sent Via Preferred Method of CommunicationBehavioural
Parents of 12-17 year-old patients due for COVID-19 booster dose will receive a one-time vaccine reminder/recall via the parent's preferred method of communication (mailed letter, text message, email)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Reminder/recall Receives: Behavioral: Reminder/Recall Sent Via Preferred Method of Communication |
| Usual Care | No intervention | No Reminder/Recall |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 Booster Dose
Number of patients that received a COVID-19 booster dose during follow-up based on electronic health data. Receipt of a COVID-19 booster dose within 90 days of randomization (yes/no) will be assessed using vaccination data available from the Marshfield Clinic Health System (MCHS) electronic health record, which includes vaccinations administered outside of MCHS through data exchanges with the Wisconsin Immunization Registry. Specifically patients will be classified as having received a COVID-19 booster dose if they have record of receipt of COVID-19 booster dose with a vaccination date during the 90-day follow-up period.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start12 May 2022
- Primary completion30 Aug 2022
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 VaccinesStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marshfield Clinic Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huong McLean, PhD, Marshfield Clinic Research Foundation
- Investigators
- Huong McLean, PhD, Principal investigator, Marshfield Clinic Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571657
- Sponsor's protocol ID
- MCL10517a
- Other IDs
- U01IP001093
- Acronym
- AIMED COVID
- Status last verified
- Oct 2022
- First submitted
- 6 Oct 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Addressing the Disparity in Vaccination Coverage Among U.S. Adolescents Living in Rural Versus Urban Areas
- ClinicalTrials.gov ID
- NCT05571657
- Acronym / sponsor ID
- AIMED COVID / MCL10517a
- Conditions
- COVID-19 Vaccines
- Keywords
- reminder/recall, COVID-19, intervention, adolescents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,304 participants (actual)
- Lead sponsor
- Marshfield Clinic Research FoundationUniversity, hospital or other
- Study start
- 12 May 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 7 Oct 2022 (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.
A single COVID-19 booster dose has been recommended in the United States for adolescents aged ≥12 years to enhance protection against SARS-CoV-2 infection. This study will assess the efficacy of a one-time reminder/recall for COVID-19 booster dose among eligible adolescents in a regional healthcare system.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Reminder/Recall Sent Via Preferred Method of CommunicationReminder/recall |
| Usual Care | No intervention | –No Reminder/Recall |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Marshfield Clinic Health System patient aged 12-17 years with at least one preventive visit or two evaluation \& management visits with a Marshfield Clinic Health System provider in the last 36 months
- Due for a COVID-19 booster dose (completed the COVID-19 primary series and it has been ≥5 months since their second dose)
Key exclusion criteria (5 listed)
- Primary care provider is not affiliated with Marshfield Clinic Health System
- Opted out of Marshfield Clinic Health System centralized vaccine reminder notifications
- Received COVID-19 vaccine off label
- Missing or invalid contact information
- Deceased
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 |
|---|---|---|
| Reminder/Recall Sent Via Preferred Method of CommunicationParents of 12-17 year-old patients due for COVID-19 booster dose will receive a one-time vaccine reminder/recall via the parent's preferred method of communication (mailed letter, text message, email) | Behavioural | Intervention |
Primary outcome
COVID-19 Booster Dose
Time frame: 90 days
Number of patients that received a COVID-19 booster dose during follow-up based on electronic health data. Receipt of a COVID-19 booster dose within 90 days of randomization (yes/no) will be assessed using vaccination data available from the Marshfield Clinic Health System (MCHS) electronic health record, which includes vaccinations administered outside of MCHS through data exchanges with the Wisconsin Immunization Registry. Specifically patients will be classified as having received a COVID-19 booster dose if they have record of receipt of COVID-19 booster dose with a vaccination date during the 90-day follow-up period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- 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.
Huong McLean, PhD principal investigator
Marshfield Clinic Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reminder/Recall Sent Via Preferred Method of Communication in people with COVID-19 Vaccines, run by Marshfield Clinic Research Foundation 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Oct 2022. 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?
Results are not available in the source record.
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?
COVID-19 Booster Dose (time frame: 90 days). 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 13 Oct 2022.