Low Cost Interventions to Improve Adherence to Childhood Immunization Schedule - Full Text View

Sponsor:	University of Alabama at Birmingham
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00602056

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:	Supportive Care, Randomized, Open Label, Factorial Assignment
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:

MedlinePlus related topics: Caregivers Childhood Immunization

U.S. FDA Resources

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
1: Experimental Redesigned immunization card	Other: Redesigned immunization card A low cost nad simplified redesigned immunization card
2: Experimental Center based education to mothers/caregivers	Other: Center based education to mothers/caregivers A 2-3 minute center based education to mothers/caregivers
3: Experimental 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
4: No Intervention 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

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

Locations

Pakistan, Sindh
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:	University of Alabama at Bormingham ( Dr. Hussain R. Usman/Doctoral Trainee )
Study ID Numbers:	X050713007, X050713007
Study First Received:	January 13, 2008
Last Updated:	January 13, 2008
ClinicalTrials.gov Identifier:	NCT00602056 History of Changes
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 November 30, 2009