Khushi Baby (KB): Novel Mobile Health Solution for Vaccination Record Keeping in India
|ClinicalTrials.gov Identifier: NCT02518178|
Recruitment Status : Unknown
Verified August 2015 by Khushi Baby Inc..
Recruitment status was: Enrolling by invitation
First Posted : August 7, 2015
Last Update Posted : August 7, 2015
This is a three arm cluster randomized controlled trial where the unit of randomization is the immunization camp. Immunization camps are the sole provider of vaccinations in our study area and have catchment areas of several villages. The 96 immunization camps will be randomized evenly to one of three arms:
- control arm; where near field communication (NFC) stickers will be placed on existing immunization booklets. These stickers can be scanned using a mobile phone with an installed application whereby information can be entered onto the phone and then scanned onto the sticker
- pendant only; where the same NFC technology will be placed into a pendant that is worn by the infant, and
- pendant as described above with voice reminders sent 15 days, 1 day prior, and the day of the scheduled immunization camp dates.
|Condition or disease||Intervention/treatment||Phase|
|DTP Vaccine Series Completion||Device: NFC Necklace Device: Voice Reminder Device: NFC Sticker||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Khushi Baby (KB): Efficacy and Impact Assessment of Novel Mobile Health Solution for Vaccination Record Keeping in Rural Udaipur, Rajasthan, India|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||April 2016|
Active Comparator: NFC Sticker
Participants will receive an NFC (Near Field Communication) sticker, placed on their existing immunization (MAMTA) card. This will serve as a comparator to the NFC necklace while still allowing for patient data to be digitized and utilized by the health service provider, Seva Mandir.
Device: NFC Sticker
NFC Sticker on existing immunization card (MAMTA card) serves as a comparator to the pendant and pendant+voice call arms.
Experimental: NFC Necklace
Participants will receive a necklace with an NFC pendant, which interfaces with the Khushi Baby mobile application to digitize the data. This arm will allow for the assessment of peer influence effects of the necklace as a social symbol.
Device: NFC Necklace
Experimental: NFC Necklace + Voice Reminder
In addition to the NFC necklace, mothers of the participants in this arm will receive dialect-specific voice call reminders, informing them about the next camp and the importance of vaccinations.
Device: NFC Necklace
Device: Voice Reminder
Dialect-specific reminders will be issued to the mother's cell phone, informing about the upcoming immunization camp and the importance of vaccination
- 20% increase in DTP3 coverage [ Time Frame: 6 camps after DTP1 receipt (6 months) ]Comparing necklace (with or without voice call reminders) to control arm infants
- Increase in DTP3 coverage for necklace + voice reminder arm compared to other 2 arms [ Time Frame: 6 camps after DTP1 receipt (6 months) ]
- Improved camp attendance rates [ Time Frame: Over 6 camp period after DTP1 receipt (6 months) ]Comparing camps randomized to receive necklace (with or without voice reminders) to control arm infants.
- Retention of pendant compared to that of NFC stickered MAMTA card [ Time Frame: 6 camps after DTP1 receipt (6 months) ]
- Increased time efficiency of NFC system (both stickers and pendants) compared to existing paper-based system of recording immunization [ Time Frame: Paper log books (status quo control) will be used to establish a baseline for timeliness during first 2 months of the study. In the latter 2 months, the KB app digitization will be timed. ]The surveyor will categorize the times separately for new and follow-up patients. The analysis will consider average times for new registrants and follow up registrants in KB app vs. logbook for each health worker (GNM). These indicators will be used to compile a composite measure of time efficiency.
- Increased accuracy between NFC system (both stickers and pendants) compared to existing paper-based system of recording immunization [ Time Frame: In the first 2 months, the logbook records will be digitized and de-identified for each camp. In the latter 2 months, the digitization of records will take place exclusively through the KB app. ]At the end of each camp the number of child-specific syringes and complete vaccine vials will be counted by the Surveyor; these will serve as the gold standards. The analysis will examine the frequency of underreporting and overreporting of total vaccines (as determined by syringes) and of individual vaccines (as determined by complete vaccine vials when available); rates of underreporting and overreporting will be examined at the camp level (n=2 for each camp) and after clubbing all camps per month (n= 2 months). These indicators will be used to compile a composite accuracy outcome measure.
- Survey-based outcomes: user satisfaction, socio-demographic profile of infants, vaccine awareness of mothers and the differential effects on vaccination adherence [ Time Frame: Intake survey at enrollment + follow-up surveys at each camp (approximately once a month during follow-up period) ]
- Failure rate of the Khushi Baby mobile application [ Time Frame: Throughout study period of 9 months ]time series data to be collected from the app itself (error logs and internal counters for each replacement); number of entries in backup logbook will be digitized and added
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518178
|Principal Investigator:||Mohammad Shahnawaz, PhD cand||Indian Institute of Health Management Research (IIHMR)|