Mobile ApplicationNCT04449107
Evaluate the Role of a Personalized Smartphone Based Application to Improve Childhood Immunization Coverage
A study testing Android based mobile phone application in people with Mobile Application and Routine Childhood Immunization, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The vision of the investigators is to build capacity in technology-driven healthcare innovation in LMCIs. The programme will be initiated by a feasibility and proof-of-concept (POC) study to tackle the lack of awareness around immunization, which is a major health issue in developing countries. Read more about this study
- Who is it for?
- Ages 6 weeks to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Mobile Application, Routine Childhood Immunization
- What is being tested?
- Android based mobile phone application
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Feb 2020to 31 Dec 2020
- 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 6 weeks to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- parent or guardian or at least one person in the household has a working android based smart mobile phone
- ability to use android based smart phone
- Parent or guardian providing consent.
Who cannot join
- If the family will not be visiting AKU for 10- and 14-week RI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Evaluate the Role of a Personalized Smartphone-based Application to Improve Childhood Immunization Coverage and Timelines Among Children in Pakistan
The vision of the investigators is to build capacity in technology-driven healthcare innovation in LMCIs. The programme will be initiated by a feasibility and proof-of-concept (POC) study to tackle the lack of awareness around immunization, which is a major health issue in developing countries. Mobile apps and social media have been shown to be effective in various programmes worldwide, but there is limited data from LMICs on the use of digital technologies in improving routine immunization (RI) coverage.
Read the detailed description
Pakistan is one of the countries with the highest rates of child death in the world. It ranks 4th in child mortality, with 60% deaths due to vaccine-preventable diseases (VPDs). The immunization coverage in Pakistan is estimated to be 59%, which is still well below the desired level, leading to continued polio transmission, large measles outbreaks, and thousands of deaths from vaccine-preventable illnesses. In addition, Pakistan is a major polio epidemic country and among 3 countries in the world requiring proof of polio vaccination for international travel. Pakistan demographic and health survey in 2017-2018 suggests 88% percent of children had received BCG vaccine due at birth, 86% and 95% had received the first dose of pentavalent and polio vaccine respectively due at the 6th week. Furthermore, 75% and 86% of children had received the third dose of the pentavalent and polio vaccines, respectively, due at 14th week and measles vaccination was 73%, which is due at 9 months. However, these rates are at 1 year of age and much higher than vaccination coverage rate at scheduled time and among conflict hits and displaced populations. Improved RI coverage is recommended as the priority public health strategy to reduce VPDs and eradicate polio in Pakistan and worldwide.
According to immunization coverage surveys, 1 in 5 children are unimmunized. A major reason for poor childhood vaccine coverage is low immunization uptake, when parents are unable to complete the entire series of vaccines in accordance with the scheduled timelines. Some of the reasons include: (1) the family is not in favor of getting their child immunized, (2) low trust in vaccines provided through Expanded Programme on Immunization (EPI) and government health care providers, and (3) caregivers have forgotten their child's next vaccination due date or child's EPI card is misplaced. These barriers may be modified with additional support through education and behavior change strategies. In addition, with more pressing issues of food and shelter, preventive health often takes the back seat, and parents and caregivers forget or ignore the subsequent doses of vaccines for their children. There is an immense need to encourage parents' care seeking and collaboration with the health care providers to improve initial vaccine uptake and the completion of all doses according to the schedule. New innovative and cost-effective techniques are necessary for practical solutions to improve vaccination uptake and coverage.
Mobile phones offer a new medium to provide education and advocate families or caregivers to enable behavior change so as to improve immunization uptake. Mobile phone use has also increased in countries with low RI coverage and a high risk of VPDs. Good examples are Nigeria and Pakistan, where there were around 170 and 140 million mobile phone subscribers, respectively, in 2014. There are limited data from LMICs set up on the role of SMS-based interventions for improvement of RI coverage, and conventional 1-way reminder SMS text messages were used by most of the studies as the intervention. Overall, very few studies compared reminders, educational, and interactive SMS messages related to childhood vaccination uptake. Although some of the studies have shown some behavior change for improvement in vaccination coverage, more rigorous application of health behavior change model needs to be applied to understand the impact of reminder, educational, and interactive messages on behavior change related to improvement in RI coverage. However, data from developing countries regarding the role of automated calls in improving vaccine coverage are limited.
The vision of the investigators is to build capacity in technology-driven healthcare innovation in LMCIs. The programme will be initiated by a feasibility and proof-of-concept (POC) study to tackle the lack of awareness around immunization, which is a major health issue in developing countries. Mobile apps and social media have been shown to be effective in various programmes worldwide, but there is limited data from LMICs on the use of digital technologies in improving routine immunization (RI) coverage.
- Conditions
- Mobile Application, Routine Childhood Immunization
- Being tested
- Android based mobile phone application
- Keywords
- Mobile application, routine childhood immunization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Android based mobile phone applicationBehavioural
An android based mobile application will be developed. The application will have features and capacity for text messages, voice messages, pictorial messages and video messages. The content of the messages will be according to the findings of Paigham e sehat project and the four messages domains would be educational, reminder, religious and adverse effects. In addition, pictorial and video messages would be used as per freely available through EPI programme Pakistan.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | The intervention arm in addition to the standard counselling will include receiving text messages, voice messages, pictorial messages and video messages regarding vaccination once a week till the child turns 14 weeks Receives: Behavioral: Android based mobile phone application |
| Control Arm | No intervention | The control group will receive one-time standard verbal counselling at the time of initial visit for on-time EPI vaccines at 10 and 14 weeks of age as recommended by EPI, government of Pakistan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in RI coverage
to see a 10 percent increase in RI through personalized smart mobile phone-based application at 10 and 14 weeks of age according to the EPI schedule versus standard care
Measured: 12 weeks
Improvement in timeline
To see a 10 percent increase in RI within 1 week of the original timeline at 10, and 14 weeks versus standard care
Measured: 12 weeks
Secondary outcomes (2)
Perceptions and barriers related to routine immunization (Interview guide in form of in depth interview will be administered).
- Perceptions regarding risks of infectious diseases preventable by vaccines and vaccine safety and efficacy.
- Perceptions and barriers to vaccinating children including difficulties in visiting RI centers.
This will help us in understanding the types of (1) barriers perceived by caregivers, (2) designing the Randomized Controlled Trial and study methodology.
Measured: 6 weeks
perceptions and barriers of a mobile phone based application to improve immunization coverage (interview guide in form of in depth interview will be administered)
- Perceptions and barriers that may affect the use of mobile phone application in implementing the phone-based intervention to improve immunization coverage
- Usability and preferences of mobile phone app to improve routine immunization coverage
This will help in developing personalized mobile phone application and content of the messages according to the barriers of the participants to bring in behavior change in order to improve immunization coverage and timelines
Measurement tool is the 14 weeks vaccination as per EPI schedule.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start27 Feb 2020
- Primary completion30 Aug 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mobile ApplicationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A mixed methods study will be conducted in which a smart phone application will be developed based on the findings of qualitative component of the study, which will have features for text, voice, video and pictorial messages for the participant caregivers to improve RI on 10th and 14th week of child age.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- NED University of Engineering and Technology, University of Surrey
- Responsible party
- Principal investigator, Dr Abdul Momin Kazi, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449107
- Sponsor's protocol ID
- 2019-1534-5556
- Status last verified
- Jun 2020
- First submitted
- 14 Apr 2020
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The database will reside on a central computer at AKU managed by the study staff. Mobile numbers will not be shared except to track patterns of use. Only relevant study staff will have access to study data allowed by the local ethics committee. Participants' information will be given a study code, and no personal identifiers will be shared. Data confidentiality will be maintained at all times. No personal identifiers will be used in any reports or publication of the study. No individual identifier such as names of participants and area of location will be shared. In addition, a confidentiality agreement has been signed with the universities stating that the numbers provided will only be used for the purpose of the trial.
Publications
Kazi AM, Qazi SA, Khawaja S, Ahsan N, Ahmed RM, Sameen F, Khan Mughal MA, Saqib M, Ali S, Kaleemuddin H, Rauf Y, Raza M, Jamal S, Abbasi M, Stergioulas LK. An Artificial Intelligence-Based, Personalized Smartphone App to Improve Childhood Immunization Coverage and Timelines Among Children in Pakistan: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Dec 4;9(12):e22996. doi: 10.2196/22996.
PubMed 33274726
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Role of a Personalized Smartphone-based Application to Improve Childhood Immunization Coverage and Timelines Among Children in Pakistan
- ClinicalTrials.gov ID
- NCT04449107
- Acronym / sponsor ID
- 2019-1534-5556
- Conditions
- Mobile Application, Routine Childhood Immunization
- Keywords
- Mobile application, routine childhood immunization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- NED University of Engineering and Technology, University of Surrey
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 26 Jun 2020 (actual)
- 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 vision of the investigators is to build capacity in technology-driven healthcare innovation in LMCIs. The programme will be initiated by a feasibility and proof-of-concept (POC) study to tackle the lack of awareness around immunization, which is a major health issue in developing countries. Mobile apps and social media have been shown to be effective in various programmes worldwide, but there is limited data from LMICs on the use of digital technologies in improving routine immunization (RI) coverage.
Detailed description
Pakistan is one of the countries with the highest rates of child death in the world. It ranks 4th in child mortality, with 60% deaths due to vaccine-preventable diseases (VPDs). The immunization coverage in Pakistan is estimated to be 59%, which is still well below the desired level, leading to continued polio transmission, large measles outbreaks, and thousands of deaths from vaccine-preventable illnesses. In addition, Pakistan is a major polio epidemic country and among 3 countries in the world requiring proof of polio vaccination for international travel. Pakistan demographic and health survey in 2017-2018 suggests 88% percent of children had received BCG vaccine due at birth, 86% and 95% had received the first dose of pentavalent and polio vaccine respectively due at the 6th week. Furthermore, 75% and 86% of children had received the third dose of the pentavalent and polio vaccines, respectively, due at 14th week and measles vaccination was 73%, which is due at 9 months. However, these rates are at 1 year of age and much higher than vaccination coverage rate at scheduled time and among conflict hits and displaced populations. Improved RI coverage is recommended as the priority public health strategy to reduce VPDs and eradicate polio in Pakistan and worldwide.
According to immunization coverage surveys, 1 in 5 children are unimmunized. A major reason for poor childhood vaccine coverage is low immunization uptake, when parents are unable to complete the entire series of vaccines in accordance with the scheduled timelines. Some of the reasons include: (1) the family is not in favor of getting their child immunized, (2) low trust in vaccines provided through Expanded Programme on Immunization (EPI) and government health care providers, and (3) caregivers have forgotten their child's next vaccination due date or child's EPI card is misplaced. These barriers may be modified with additional support through education and behavior change strategies. In addition, with more pressing issues of food and shelter, preventive health often takes the back seat, and parents and caregivers forget or ignore the subsequent doses of vaccines for their children. There is an immense need to encourage parents' care seeking and collaboration with the health care providers to improve initial vaccine uptake and the completion of all doses according to the schedule. New innovative and cost-effective techniques are necessary for practical solutions to improve vaccination uptake and coverage.
Mobile phones offer a new medium to provide education and advocate families or caregivers to enable behavior change so as to improve immunization uptake. Mobile phone use has also increased in countries with low RI coverage and a high risk of VPDs. Good examples are Nigeria and Pakistan, where there were around 170 and 140 million mobile phone subscribers, respectively, in 2014. There are limited data from LMICs set up on the role of SMS-based interventions for improvement of RI coverage, and conventional 1-way reminder SMS text messages were used by most of the studies as the intervention. Overall, very few studies compared reminders, educational, and interactive SMS messages related to childhood vaccination uptake. Although some of the studies have shown some behavior change for improvement in vaccination coverage, more rigorous application of health behavior change model needs to be applied to understand the impact of reminder, educational, and interactive messages on behavior change related to improvement in RI coverage. However, data from developing countries regarding the role of automated calls in improving vaccine coverage are limited.
The vision of the investigators is to build capacity in technology-driven healthcare innovation in LMCIs. The programme will be initiated by a feasibility and proof-of-concept (POC) study to tackle the lack of awareness around immunization, which is a major health issue in developing countries. Mobile apps and social media have been shown to be effective in various programmes worldwide, but there is limited data from LMICs on the use of digital technologies in improving routine immunization (RI) coverage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A mixed methods study will be conducted in which a smart phone application will be developed based on the findings of qualitative component of the study, which will have features for text, voice, video and pictorial messages for the participant caregivers to improve RI on 10th and 14th week of child age.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Android based mobile phone applicationThe intervention arm in addition to the standard counselling will include receiving text messages, voice messages, pictorial messages and video messages regarding vaccination once a week till the child turns 14 weeks |
| Control Arm | No intervention | –The control group will receive one-time standard verbal counselling at the time of initial visit for on-time EPI vaccines at 10 and 14 weeks of age as recommended by EPI, government of Pakistan. |
Who may qualify
- Ages
- 6 weeks to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- parent or guardian or at least one person in the household has a working android based smart mobile phone
- ability to use android based smart phone
- Parent or guardian providing consent.
Key exclusion criteria (1 listed)
- If the family will not be visiting AKU for 10- and 14-week RI.
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 |
|---|---|---|
| Android based mobile phone applicationAn android based mobile application will be developed. The application will have features and capacity for text messages, voice messages, pictorial messages and video messages. The content of the messages will be according to the findings of Paigham e sehat project and the four messages domains would be educational, reminder, religious and adverse effects. In addition, pictorial and video messages would be used as per freely available through EPI programme Pakistan. | Behavioural | Intervention Arm |
Primary outcome
improvement in RI coverage
Time frame: 12 weeks
to see a 10 percent increase in RI through personalized smart mobile phone-based application at 10 and 14 weeks of age according to the EPI schedule versus standard care
Improvement in timeline
Time frame: 12 weeks
To see a 10 percent increase in RI within 1 week of the original timeline at 10, and 14 weeks versus standard care
2 secondary outcomes
Perceptions and barriers related to routine immunization (Interview guide in form of in depth interview will be administered).
Time frame: 6 weeks
perceptions and barriers of a mobile phone based application to improve immunization coverage (interview guide in form of in depth interview will be administered)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Derived from this study: PubMed 33274726Kazi AM, Qazi SA, Khawaja S, Ahsan N, Ahmed RM, Sameen F, Khan Mughal MA, Saqib M, Ali S, Kaleemuddin H, Rauf Y, Raza M, Jamal S, Abbasi M, Stergioulas LK. An Artificial Intelligence-Based, Personalized Smartphone App to Improve Childhood Immunization Coverage and Timelines Among Children in Pakistan: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Dec 4;9(12):e22996. doi: 10.2196/22996.
- Individual participant dataSharing planned: No. The database will reside on a central computer at AKU managed by the study staff. Mobile numbers will not be shared except to track patterns of use. Only relevant study staff will have access to study data allowed by the local ethics committee. Participants' information will be given a study code, and no personal identifiers will be shared. Data confidentiality will be maintained at all times. No personal identifiers will be used in any reports or publication of the study. No individual identifier such as names of participants and area of location will be shared. In addition, a confidentiality agreement has been signed with the universities stating that the numbers provided will only be used for the purpose of the trial.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Android based mobile phone application in people with Mobile Application and Routine Childhood Immunization, 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 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: status not confirmed, as of the sponsor's last update on 26 Jun 2020. 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?
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?
improvement in RI coverage (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04449107, which also lists 1 linked publication.
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 Jun 2020.