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
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
-
-
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
|
A low cost nad simplified redesigned immunization card
|
|
Experimental: 2
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
|
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.
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
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.