PRIMM Trial (Phone Reminder for IMMunization)
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|ClinicalTrials.gov Identifier: NCT02819895|
Recruitment Status : Active, not recruiting
First Posted : June 30, 2016
Last Update Posted : June 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Immunization||Other: A customized windows® software application||Not Applicable|
Background: Worldwide, vaccine preventable diseases account for 29% of all deaths between 1 month and 5 years, underscoring the importance of immunizations. In Nigeria, routine childhood immunization rates are unacceptably inconsistent and low, ranging from 35-85% at 14 weeks and 10-37% for all routine immunizations at 12-24 months.
GAP: The feasibility, acceptability and utility of an automated phone immunization reminder system have never been explored in this rural setting of Nigeria.
HYPOTHESIS: Given ~90% of the adult population in Nigeria uses a mobile phone, a customized mHealth immunization reminder system will be feasible and acceptable; and will significantly improve immunization rates in this rural setting of Ondo State, Nigeria.
METHODS: A prospective randomized controlled trial study design will be utilized. This study will recruit parents of healthy newborn infants delivered at Mother and Child Hospital Ondo, who live in Akure or Ondo Town and plan to receive their immunizations at Mother and Child Hospital Ondo.
DATA ANALYSIS: The proportion of immunization visits between intervention and control groups will be compared using a two-sided, two sample test of proportions with p <0.05 being significant. Secondary analysis will focus on the predictive value of social demographic variables on immunization rates.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||PRIMM Trial (Phone Reminder for IMMunization) in Ondo State, Nigeria|
|Actual Study Start Date :||July 2016|
|Actual Primary Completion Date :||July 31, 2017|
|Estimated Study Completion Date :||June 30, 2018|
Parents of healthy newborn infants delivered at Mother and Child Hospital Ondo (Akure or Ondo), who live in Akure or Ondo Town and plan to receive their immunizations at MCH Ondo will receive their usual care (an immunization card). In addition they will received automated text, calls and emails (if applicable) reminders through a customized windows® software application when their child's immunization visit is due.
Other: A customized windows® software application
A customized windows® software application with the ability to send automated voice call, SMS and email reminder about due dates for childhood routine immunizations.
No Intervention: Control
Parents of healthy newborn infants delivered at Mother and Child Hospital Ondo (Akure or Ondo), who live in Akure or Ondo Town and plan to receive their immunizations at MCH Ondo will receive usual care (an immunization card)
- Immunization Rates at 14 weeks [ Time Frame: 14 Weeks ]To determine if an automated customized telephone and email immunization reminder system can increase the 14-week immunization rates, by at least 10% among those who receive immunization reminders versus those who do not.
- Immunization Rates at 14 Months [ Time Frame: 14 Months ]To determine the effect of an automated customized phone and email immunization reminder system on the proportion of children completely immunized at 14 months among those who receive immunization reminders versus those who do not.
- Timeliness of Immunization Receipt [ Time Frame: 14 Months ]To determine if the proportion of infants who receive their immunizations within 1-week of its due date is higher in infants of parents who receive phone and email immunization reminders versus those who do not.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819895
|Mother and Child Hospital Ondo|
|Akure, Ondo State, Nigeria, 11111|
|Mother and Child Hospital Ondo|
|Ondo, Nigeria, 11111|
|Principal Investigator:||Osayame Ekhaguere, MBBS, MPH||Children's Hospital of Philadelphia|
|Study Director:||Andrew Steenhoff, MBBCh||Children's Hospital of Philadelphia|
|Study Director:||Elizbeth Lowenthal, MD, MSCE||Children's Hospital of Philadelphia|