Low Cost Interventions to Improve Adherence to Childhood Immunization Schedule

This study has been completed.
Sponsor:
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00602056
First received: January 13, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Childhood Immunization Completion
Childhood Immunization Dropout
Immunization Card
Center Based Education
Other: Redesigned immunization card
Other: Center based education to mothers/caregivers
Other: Redesigned immunization card with center based education to mother/caregivers

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trial of Low Cost Interventions to Improve Adherence to Childhood Immunization Schedule in a Low Literacy Population in Pakistan

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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 ]

Enrollment: 1506
Study Start Date: November 2005
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 365 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All children visiting the selected EPI centers for DPT1 immunization

Exclusion Criteria:

  • Not residing in the same area for last six months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602056

Locations
Pakistan
EPI immunization centers
Karachi, Sindh, Pakistan
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Hussain R Usman, MBBS, MS University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Dr. Hussain R. Usman/Doctoral Trainee, University of Alabama at Bormingham
ClinicalTrials.gov Identifier: NCT00602056     History of Changes
Other Study ID Numbers: X050713007, X050713007
Study First Received: January 13, 2008
Last Updated: January 13, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Immunization dropout
Immunization card
Center based education

ClinicalTrials.gov processed this record on October 29, 2014