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- Klinische proef NCT02819895
PRIMM Trial (Phone Reminder for IMMunization)
PRIMM Trial (Phone Reminder for IMMunization) in Ondo State, Nigeria
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Ondo, Niger, 11111
- Mother and Child Hospital Ondo
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Ondo State
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Akure, Ondo State, Niger, 11111
- Mother and Child Hospital Ondo
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- Parents of infants requiring hospital admission due to illness or prematurity.
- Parents without a cellular phone
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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A customized windows® software application with the ability to send automated voice call, SMS and email reminder about due dates for childhood routine immunizations.
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Geen tussenkomst: 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)
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Immunization Rates at 14 weeks
Tijdsspanne: 14 Weeks
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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.
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14 Weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Immunization Rates at 14 Months
Tijdsspanne: 14 Months
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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.
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14 Months
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Timeliness of Immunization Receipt
Tijdsspanne: 14 Months
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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.
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14 Months
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Osayame Ekhaguere, MBBS, MPH, Children's Hospital of Philadelphia
- Studie directeur: Andrew Steenhoff, MBBCh, Children's Hospital of Philadelphia
- Studie directeur: Elizbeth Lowenthal, MD, MSCE, Children's Hospital of Philadelphia
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 15-012572
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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