COVID-19 Booster Dose Reminder/Recall for Adolescents

NCT ID: NCT05571657

Last Updated: 2022-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

4304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-12

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19 Vaccines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention

Reminder/recall

Group Type EXPERIMENTAL

Reminder/Recall Sent Via Preferred Method of Communication

Intervention Type BEHAVIORAL

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)

Usual Care

No Reminder/Recall

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Reminder/Recall Sent Via Preferred Method of Communication

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)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marshfield Clinic Research Foundation

OTHER

Sponsor Role lead

Responsible Party

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Huong McLean, PhD

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huong McLean, PhD

Role: PRINCIPAL_INVESTIGATOR

Marshfield Clinic Research Institute

Locations

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Marshfield Clinic Health System

Marshfield, Wisconsin, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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U01IP001093

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MCL10517a

Identifier Type: -

Identifier Source: org_study_id

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