- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02819895
PRIMM Trial (Phone Reminder for IMMunization)
PRIMM Trial (Phone Reminder for IMMunization) in Ondo State, Nigeria
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Ondo, Nigeria, 11111
- Mother and Child Hospital Ondo
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Ondo State
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Akure, Ondo State, Nigeria, 11111
- Mother and Child Hospital Ondo
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Aucune 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)
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Immunization Rates at 14 weeks
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Immunization Rates at 14 Months
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Osayame Ekhaguere, MBBS, MPH, Children's Hospital of Philadelphia
- Directeur d'études: Andrew Steenhoff, MBBCh, Children's Hospital of Philadelphia
- Directeur d'études: Elizbeth Lowenthal, MD, MSCE, Children's Hospital of Philadelphia
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 15-012572
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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