Mhealth Supported Bundle to Improve Vaccination Completion

April 11, 2024 updated by: Osayame Ekhaguere, Indiana University

Implementing a Mobile Health Supported Bundle to Improve Routine Vaccination Completion Rate in a Low-resource Setting

Supported be a digital vaccine registry the investigators will test the impact of automated appointment reminders, real time appointment reminders, motivational interviewing and targeted vaccine on routine childhood vaccine completion rates.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Bundling three high-impact mHealth interventions (a digital vaccine registry (supply side), a reminder system (demand side), and targeted vaccine drive (demand and supply-side) will be feasible, acceptable, carried out with fidelity, and result in a 10% improvement in vaccine completion rates compared to the year prior to implementation.

Study Type

Interventional

Enrollment (Estimated)

1250

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 Contact

  • Name: Osayame A Ekhaguere, MBBS, MPH
  • Phone Number: (317) 944 3691
  • Email: osaekhag@iu.edu

Study Contact Backup

  • Name: Rosena O Oluwafemi, MBCHB, MPH
  • Phone Number: +2348034101163
  • Email: bankyfem@yahoo.com

Study Locations

  • Nigeria
    • Ondo
      • Akure, Ondo, Nigeria, 1111
        • Recruiting
        • Mother and Child Hospital Akure
        • Contact:
          • A
        • Contact:
        • Sub-Investigator:
          • Rosena O Oluwafemi, MBBCh
        • Principal Investigator:
          • Osayame A Ekhaguere, MBBS

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • All parents or caregivers of patients who bring their child to the vaccine clinic to receive immunization for their first vaccine visit.

Exclusion Criteria:

  • Parents or caregivers not willing to participate.

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: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Prospectively received appointment reminders, motivational interviews and targeted vaccine drives.
Behavioral: Appointment reminders, motivational interviewing and targeted vaccine drives
Automated and real time phone call reminders, motivational interviewing and targeted vaccine drives applied in sequence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccine completion rates
Time Frame: 15 Months
Receipt of all routine childhood vaccines
15 Months

Collaborators and Investigators

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

Sponsor

Indiana University

Collaborators

National Center for Advancing Translational Sciences (NCATS)

Investigators

  • Principal Investigator: Osayame A Ekhaguere, Indiana University

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)

November 1, 2022

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

August 26, 2022

First Submitted That Met QC Criteria

August 26, 2022

First Posted (Actual)

August 30, 2022

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15107 (CTSRMC, Abramson Cancer Center, University of Pennsylvania)
  • UL1TR002529 (U.S. NIH Grant/Contract)
  • KL2TR002530 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Publish a study protocol in an open access journal. Provider study data set on request.

IPD Sharing Time Frame

Protocol: Within 6 month of study start Data set: After study completion.

IPD Sharing Access Criteria

One request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

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.

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