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PRIMM Trial (Phone Reminder for IMMunization)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02819895
First Posted: June 30, 2016
Last Update Posted: June 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Osayame Ekhaguere, Children's Hospital of Philadelphia
  Purpose
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.

Condition Intervention
Immunization Other: A customized windows® software application

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Other
Official Title: PRIMM Trial (Phone Reminder for IMMunization) in Ondo State, Nigeria

Further study details as provided by Osayame Ekhaguere, Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 600
Actual Study Start Date: July 2016
Estimated Study Completion Date: May 31, 2018
Estimated Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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 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)

Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Week   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Nigeria
Mother and Child Hospital Ondo
Akure, Ondo State, Nigeria, 11111
Mother and Child Hospital Ondo
Ondo, Nigeria, 11111
Sponsors and Collaborators
Children's Hospital of Philadelphia
Thrasher Research Fund
Investigators
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
  More Information

Responsible Party: Osayame Ekhaguere, MBBS MPH, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02819895     History of Changes
Other Study ID Numbers: IRB 15-012572
First Submitted: June 24, 2016
First Posted: June 30, 2016
Last Update Posted: June 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Osayame Ekhaguere, Children's Hospital of Philadelphia:
Phone Appointment Reminder
Immunization Rates
mHealth

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs