Vaccination FailureNCT01908946
Automated SMS Reminders to Parents on Their Cell Phones Can Significantly Improve the on Time Vaccination Rates Children in Pakistan
A study testing SMS reminders in people with Vaccination Failure, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The investigators plan to test the effectiveness of reminders to parents/guardians on cell phones through short messaging system (SMS) in improving the on-time routine immunization for children in Pakistan. SMS message as a reminder tool can be very effective in health care settings at public health scale. Read more about this study
- Who is it for?
- Ages Up to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Vaccination Failure
- What is being tested?
- SMS reminders
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 sitePakistan
- Study dates
- May 2013to Oct 2013
- 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 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child should be less than 14 days of age
- Parent/guardian or at least one person in the household having a valid cell phone connection
- Parent/guardian provides consent
Who cannot join
- Child more than 14 days of age
- Not a valid cell phone connection in the household
- Parent/guardian not providing consent
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University
Karachi, Sindh, 74800
Abdul M Kazi, MBBs,MPH, +92 21 34864335, momin.kazi@aku.edu
About this study
Official title: Automated SMS Reminders to Parents on Their Cell Phones Can Significantly Improve the on Time Vaccination Rates Among Children in Pakistan
The investigators plan to test the effectiveness of reminders to parents/guardians on cell phones through short messaging system (SMS) in improving the on-time routine immunization for children in Pakistan. SMS message as a reminder tool can be very effective in health care settings at public health scale. This study will be conducted in an urban- squatter settlement area, Ibrahim Haidry union council in Karachi. Parents/guardians of children randomized in intervention arm will be sent SMS reminders vaccination visit reminders at 6, 10 and 14 weeks of life.
Read the detailed description
The immunization coverage in Pakistan is still well below the desired level, leading to continued polio transmission, large measles outbreaks and thousands of deaths from vaccine-preventable illnesses. A major reason for poor childhood vaccine coverage is the lack of awareness among parents regarding the need for immunization in children, and the importance of completing the entire series of vaccines. This result in significant drop-out between vaccines delivered at birth and later in the infancy period. Customized short messaging system (SMS) text can be designed as personally tailored messages to remind and inquire parents regarding vaccination for their children according to the EPI schedule. We plan to test the effectiveness of reminders to parents/guardians on cell phones through short messaging system (SMS) in improving the on-time routine immunization for children in Pakistan. This study will be conducted in an urban- squatter settlement area, Ibrahim Haidry union council in Karachi, Pakistan. Our experimental plan has three components: First, we will conduct baseline survey of parents at our study site to explore their preferences for text for immunization reminders. Simultaneously, we will develop a computerized application for reminders scheduling. This application will contain the phone number, message information, language preferences and date on which the message will be sent. It will be interfaced with the gateway to send the message. Lastly, we will conduct a randomized controlled trial to determine the effectiveness of automated SMS reminders to parents in improving the on-time vaccination rates in children. If the result shows that the vaccines compliance can be increased through the SMS reminders, this program can be incorporated with the existing systems to collect the cell phone numbers of parents at the time of child's first contact with the health system and sending auto generated reminders for vaccine compliance at national level.
- Conditions
- Vaccination Failure
- Being tested
- SMS reminders
- Keywords
- Polio
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS remindersBehavioural
SMS reminders for vaccination visit at 6, 10 and 14 weeks of life.
| Study group | Role | What they receive |
|---|---|---|
| SMS Reminders | Experimental | SMS reminders Receives: Behavioral: SMS reminders |
| Standard verbal counseling | No intervention | One time standard verbal counseling at the time of initial visit and timing for EPI vaccines at 6, 10 and 14 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in the vaccination coverage due to SMS reminders
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccination FailureStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization
- Responsible party
- Principal investigator, Dr Abdul Momin Kazi, Aga Khan University
- Investigators
- Ibrahim M Abdel Rahim, MBBS, Study director, Ibrahim Mohamed ABDEL RAHIM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908946
- Sponsor's protocol ID
- EM-2013-IER-RPC-TSA-008
- Status last verified
- Jul 2013
- First submitted
- 15 Jul 2013
- Last updated
- 26 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated SMS Reminders to Parents on Their Cell Phones Can Significantly Improve the on Time Vaccination Rates Among Children in Pakistan
- ClinicalTrials.gov ID
- NCT01908946
- Acronym / sponsor ID
- EM-2013-IER-RPC-TSA-008
- Conditions
- Vaccination Failure
- Keywords
- Polio
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- World Health Organization
- Study start
- May 2013
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 26 Jul 2013 (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 investigators plan to test the effectiveness of reminders to parents/guardians on cell phones through short messaging system (SMS) in improving the on-time routine immunization for children in Pakistan. SMS message as a reminder tool can be very effective in health care settings at public health scale. This study will be conducted in an urban- squatter settlement area, Ibrahim Haidry union council in Karachi. Parents/guardians of children randomized in intervention arm will be sent SMS reminders vaccination visit reminders at 6, 10 and 14 weeks of life.
Detailed description
The immunization coverage in Pakistan is still well below the desired level, leading to continued polio transmission, large measles outbreaks and thousands of deaths from vaccine-preventable illnesses. A major reason for poor childhood vaccine coverage is the lack of awareness among parents regarding the need for immunization in children, and the importance of completing the entire series of vaccines. This result in significant drop-out between vaccines delivered at birth and later in the infancy period. Customized short messaging system (SMS) text can be designed as personally tailored messages to remind and inquire parents regarding vaccination for their children according to the EPI schedule. We plan to test the effectiveness of reminders to parents/guardians on cell phones through short messaging system (SMS) in improving the on-time routine immunization for children in Pakistan. This study will be conducted in an urban- squatter settlement area, Ibrahim Haidry union council in Karachi, Pakistan. Our experimental plan has three components: First, we will conduct baseline survey of parents at our study site to explore their preferences for text for immunization reminders. Simultaneously, we will develop a computerized application for reminders scheduling. This application will contain the phone number, message information, language preferences and date on which the message will be sent. It will be interfaced with the gateway to send the message. Lastly, we will conduct a randomized controlled trial to determine the effectiveness of automated SMS reminders to parents in improving the on-time vaccination rates in children. If the result shows that the vaccines compliance can be increased through the SMS reminders, this program can be incorporated with the existing systems to collect the cell phone numbers of parents at the time of child's first contact with the health system and sending auto generated reminders for vaccine compliance at national level.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMS Reminders | Experimental | Behavioral: SMS remindersSMS reminders |
| Standard verbal counseling | No intervention | –One time standard verbal counseling at the time of initial visit and timing for EPI vaccines at 6, 10 and 14 weeks |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child should be less than 14 days of age
- Parent/guardian or at least one person in the household having a valid cell phone connection
- Parent/guardian provides consent
Key exclusion criteria (3 listed)
- Child more than 14 days of age
- Not a valid cell phone connection in the household
- Parent/guardian not providing consent
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 |
|---|---|---|
| SMS remindersSMS reminders for vaccination visit at 6, 10 and 14 weeks of life. | Behavioural | SMS Reminders |
Primary outcome
Improvement in the vaccination coverage due to SMS reminders
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2013.
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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.
Ibrahim M Abdel Rahim, MBBS study director
Ibrahim Mohamed ABDEL RAHIM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS reminders in people with Vaccination Failure, run by Aga Khan University 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Jul 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdul M Kazi, MBBS,MPH (+92 21 34864335, momin.kazi@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in the vaccination coverage due to SMS reminders (time frame: 12 weeks). 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 26 Jul 2013.