Childhood Immunization CompletionNCT00602056
Low Cost Interventions to Improve Adherence to Childhood Immunization Schedule
A study testing Redesigned immunization card, Center based education to mothers/caregivers and Redesigned immunization card with center based education to mother/caregivers in people with Childhood Immunization Completion and Childhood Immunization Dropout, run by University of Alabama at Birmingham at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 365 days
- Conditions the study is for
- Childhood Immunization Completion, Childhood Immunization Dropout, Immunization Card
- What is being tested?
- Redesigned immunization card, Center based education to mothers/caregivers and Redesigned immunization card with center based education to mother/caregivers
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,506 participants
- Where
- 1 sitePakistan
- Study dates
- Nov 2005to Aug 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 365 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children visiting the selected EPI centers for DPT1 immunization
Who cannot join
- Not residing in the same area for last six months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Childhood Immunization Completion, Childhood Immunization Dropout, Immunization Card, Center Based Education
- Being tested
- Redesigned immunization card, Center based education to mothers/caregivers, Redesigned immunization card with center based education to mother/caregivers
- Keywords
- Immunization dropout, Immunization card, Center based education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Redesigned immunization cardOther
A low cost nad simplified redesigned immunization card
Center based education to mothers/caregiversOther
A 2-3 minute center based education to mothers/caregivers
Redesigned immunization card with center based education to mother/caregiversOther
Redesigned immunization card with center based education to mother/caregivers
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Redesigned immunization card Receives: Other: Redesigned immunization card |
| 2 | Experimental | Center based education to mothers/caregivers Receives: Other: Center based education to mothers/caregivers |
| 3 | Experimental | Redesigned immunization card with center based education to mothers/caregivers Receives: Other: Redesigned immunization card with center based education to mother/caregivers |
| 4 | No intervention | Standard care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
The study outcome in each study group was the immunization status categorized into "DPT3 completed" and "DPT3 not completed".
Measured: 90 day follow-up after enrollment at DPT1 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startNov 2005
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Immunization CompletionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,506 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Investigators
- Hussain R Usman, MBBS, MS, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00602056
- Sponsor's protocol ID
- X050713007
- Other IDs
- X050713007
- Status last verified
- Jan 2008
- First submitted
- 13 Jan 2008
- Last updated
- 28 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Low Cost Interventions to Improve Adherence to Childhood Immunization Schedule in a Low Literacy Population in Pakistan
- ClinicalTrials.gov ID
- NCT00602056
- Acronym / sponsor ID
- X050713007
- Conditions
- Childhood Immunization Completion, Childhood Immunization Dropout, Immunization Card, Center Based Education
- Keywords
- Immunization dropout, Immunization card, Center based education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,506 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Redesigned immunization cardRedesigned immunization card |
| 2 | Experimental | Other: Center based education to mothers/caregiversCenter based education to mothers/caregivers |
| 3 | Experimental | Other: Redesigned immunization card with center based education to mother/caregiversRedesigned immunization card with center based education to mothers/caregivers |
| 4 | No intervention | –Standard care only |
Who may qualify
- Ages
- Up to 365 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children visiting the selected EPI centers for DPT1 immunization
Key exclusion criteria (1 listed)
- Not residing in the same area for last six months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Redesigned immunization cardA low cost nad simplified redesigned immunization card | Other | 1 |
| Center based education to mothers/caregiversA 2-3 minute center based education to mothers/caregivers | Other | 2 |
| Redesigned immunization card with center based education to mother/caregiversRedesigned immunization card with center based education to mother/caregivers | Other | 3 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2008.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hussain R Usman, MBBS, MS principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Redesigned immunization card, Center based education to mothers/caregivers and Redesigned immunization card with center based education to mother/caregivers in people with Childhood Immunization Completion and Childhood Immunization Dropout, run by University of Alabama at Birmingham at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2008.