Mobile Health-based Motivational Interviewing to Promote COVID-19 Vaccination (COVID-19)

March 17, 2025 updated by: Ashlea Braun, Oklahoma State University

Mobile Health-based Motivational Interviewing to Promote Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccination in Oklahomans

The objective of this study is to evaluate the preliminary efficacy and acceptability of an mobile Health-based motivational interviewing (MI) intervention to promote SARS-CoV-2 vaccination (MOTIVACC) compared to traditional phone-based MI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma
      • Stillwater, Oklahoma, United States, 74078
        • Oklahoma State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • >18 years
  • Reside in a rural area
  • No previous dose of a SARS-CoV-2 vaccine
  • Speak English
  • Able to provide informed consent

Exclusion Criteria:

  • A cognitive or other disability that inhibits smart phone use
  • Inability to participate because of medical or psychiatric conditions diagnosed by a physician/clinician
  • Enrollment in other COVID-19 research; pregnant or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard MI
Behavioral: Standard MI
One phone-based MI session
Behavioral: Ecological momentary assessment (EMA) messages
EMA messages focused on vaccinations and health
Experimental: Intensive MI
Behavioral: Ecological momentary assessment (EMA) messages
EMA messages focused on vaccinations and health
Behavioral: Intensive MI
Four phone-based MI sessions
Experimental: MOTIVACC
Behavioral: Ecological momentary assessment (EMA) messages
EMA messages focused on vaccinations and health
Behavioral: MOTIVACC
mHealth-based MI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in vaccine hesitancy and confidence
Time Frame: Baseline and follow-up (8 weeks)
Baseline and follow-up (8 weeks)
Changes in intention to receive the vaccine
Time Frame: Baseline and follow-up (8 weeks)
Baseline and follow-up (8 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in expectations related to vaccines
Time Frame: Baseline and follow-up (8 weeks)
Baseline and follow-up (8 weeks)
Changes in self-efficacy
Time Frame: Baseline and follow-up (8 weeks)
Baseline and follow-up (8 weeks)
Changes in ambivalence
Time Frame: Baseline and follow-up (8 weeks)
Baseline and follow-up (8 weeks)
Changes in value-behavior discrepancy
Time Frame: Baseline and follow-up (8 weeks)
Baseline and follow-up (8 weeks)
Number of participants who receive the COVID-19 vaccine
Time Frame: Follow-up (8 weeks)
Follow-up (8 weeks)

Other Outcome Measures

Outcome Measure
Time Frame
Percentage of total of ecological momentary assessment messages opened/viewed
Time Frame: 8 weeks (from baseline to follow up)
8 weeks (from baseline to follow up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oklahoma State University

Collaborators

University of Oklahoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

March 1, 2025

Study Completion (Actual)

March 1, 2025

Study Registration Dates

First Submitted

July 30, 2023

First Submitted That Met QC Criteria

August 2, 2023

First Posted (Actual)

August 4, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • IRB-22-282-STW

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vaccination Hesitancy

Clinical Trials on Standard MI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe