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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 6, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

June 24, 2016
June 30, 2016
June 6, 2017
July 2016
December 31, 2017   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02819895 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
PRIMM Trial (Phone Reminder for IMMunization)
PRIMM Trial (Phone Reminder for IMMunization) in Ondo State, Nigeria
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Other
Immunization
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.
  • 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.
    Intervention: Other: A customized windows® software application
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
600
May 31, 2018
December 31, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 1 Week   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Nigeria
 
 
NCT02819895
IRB 15-012572
Yes
Not Provided
Plan to Share IPD: No
Osayame Ekhaguere, Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
Thrasher Research Fund
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
Children's Hospital of Philadelphia
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP