Low Cost Interventions to Improve Adherence to Childhood Immunization Schedule - Tabular View

Tracking Information

First Received Date ^ICMJE

January 13, 2008

Last Updated Date

January 13, 2008

Start Date ^ICMJE

November 2005

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Low Cost Interventions to Improve Adherence to Childhood Immunization Schedule

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care, Randomized, Open Label, Factorial Assignment

Condition ^ICMJE

Childhood Immunization Completion
Childhood Immunization Dropout
Immunization Card
Center Based Education

Intervention ^ICMJE

Other: Redesigned immunization card
Other: Center based education to mothers/caregivers
Other: Redesigned immunization card with center based education to mother/caregivers

Study Arms / Comparison Groups

Experimental: Redesigned immunization card
Experimental: Center based education to mothers/caregivers
Experimental: Redesigned immunization card with center based education to mothers/caregivers
No Intervention: Standard care only

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1506

Completion Date

August 2006

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

All children visiting the selected EPI centers for DPT1 immunization

Exclusion Criteria:

Not residing in the same area for last six months.

Gender

Both

Ages

up to 365 Days

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Pakistan

Administrative Information

NCT ID ^ICMJE

NCT00602056

Responsible Party

Dr. Hussain R. Usman/Doctoral Trainee, University of Alabama at Bormingham

Study ID Numbers ^ICMJE

X050713007, X050713007

Study Sponsor ^ICMJE

University of Alabama at Birmingham

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Hussain R Usman, MBBS, MS

University of Alabama at Birmingham

Information Provided By

University of Alabama at Birmingham

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP