Low Cost Interventions to Improve Adherence to Childhood Immunization Schedule

January 13, 2008 updated by: University of Alabama at Birmingham

A Randomized Controlled Trial of Low Cost Interventions to Improve Adherence to Childhood Immunization Schedule in a Low Literacy Population in Pakistan

The objective of the study was to assess the effect of 1) redesigned immunization card, 2) center-based education to mothers, and 3) redesigned card with center-based education to mothers, provided at DPT1, on DPT3 completion in a randomized controlled trial at rural Expanded Programme on Immunization (EPI) centers in Karachi, Pakistan.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1506

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

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • EPI immunization centers

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

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All children visiting the selected EPI centers for DPT1 immunization

Exclusion Criteria:

  • Not residing in the same area for last six months.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Redesigned immunization card
Other: Redesigned immunization card
A low cost nad simplified redesigned immunization card
Experimental: 2
Center based education to mothers/caregivers
Other: Center based education to mothers/caregivers
A 2-3 minute center based education to mothers/caregivers
Experimental: 3
Redesigned immunization card with center based education to mothers/caregivers
Other: Redesigned immunization card with center based education to mother/caregivers
Redesigned immunization card with center based education to mother/caregivers
No Intervention: 4
Standard care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The study outcome in each study group was the immunization status categorized into "DPT3 completed" and "DPT3 not completed".
Time Frame: 90 day follow-up after enrollment at DPT1 visit
90 day follow-up after enrollment at DPT1 visit

Collaborators and Investigators

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

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Hussain R Usman, MBBS, MS, University of Alabama at Birmingham

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

November 1, 2005

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

January 13, 2008

First Submitted That Met QC Criteria

January 13, 2008

First Posted (Estimate)

January 28, 2008

Study Record Updates

Last Update Posted (Estimate)

January 28, 2008

Last Update Submitted That Met QC Criteria

January 13, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • X050713007

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 Childhood Immunization Completion

Clinical Trials on Redesigned immunization card

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe