PRIMM Trial (Phone Reminder for IMMunization)

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Immunization

Treatments: Other: A customized windows® software application

Study type: Interventional

Funder types: Other

Identifiers

NCT02819895

15-012572

Details and patient eligibility

About

The purpose of this study is to determine if in a rural setting of Ondo State, Nigeria, a customized automated telephone and email immunization reminder system will be feasible, acceptable, and significantly improve immunization utilization rates.

Full description

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.

Enrollment: 600 patients

Sex: All

Ages: 1 day to 1 week old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Parents of healthy infants who have a cellular phone
2. Born at Mother and Child Hospital Ondo (Akure or Ondo Town)
3. Plans to receive immunizations at Mother and Child Hospital Ondo

Exclusion criteria

1. Parents of infants requiring hospital admission due to illness or prematurity.
2. Parents without a cellular phone

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Other: A customized windows® software application

Control

No Intervention group

Description:

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)