NCT02819895

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

1.1 years

First QC Date

June 24, 2016

Last Update Submit

July 17, 2018

Conditions

Immunization

Keywords

Phone Appointment ReminderImmunization RatesmHealth

Outcome Measures

Primary Outcomes (1)

  • Immunization Rates at 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.

    14 Weeks

Secondary Outcomes (2)

  • Immunization Rates at 14 Months

    14 Months

  • Timeliness of Immunization Receipt

    14 Months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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)

Interventions

A customized windows® software applicationOTHER

A customized windows® software application with the ability to send automated voice call, SMS and email reminder about due dates for childhood routine immunizations.

Intervention

Eligibility Criteria

Age1 Day - 1 Week
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mother and Child Hospital Ondo

Akure, Ondo State, 11111, Nigeria

Location

Mother and Child Hospital Ondo

Ondo, 11111, Nigeria

Location

Related Publications (1)

  • Ekhaguere OA, Oluwafemi RO, Badejoko B, Oyeneyin LO, Butali A, Lowenthal ED, Steenhoff AP. Automated phone call and text reminders for childhood immunisations (PRIMM): a randomised controlled trial in Nigeria. BMJ Glob Health. 2019 Apr 3;4(2):e001232. doi: 10.1136/bmjgh-2018-001232. eCollection 2019.

    PMID: 31139442DERIVED

Study Officials

  • Osayame Ekhaguere, MBBS, MPH

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

  • Andrew Steenhoff, MBBCh

    Children's Hospital of Philadelphia

    STUDY DIRECTOR

  • Elizbeth Lowenthal, MD, MSCE

    Children's Hospital of Philadelphia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2016

First Posted

June 30, 2016

Study Start

July 1, 2016

Primary Completion

July 31, 2017

Study Completion

June 30, 2018

Last Updated

July 18, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

NG(2)