- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02819895
PRIMM Trial (Phone Reminder for IMMunization)
PRIMM Trial (Phone Reminder for IMMunization) in Ondo State, Nigeria
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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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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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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.
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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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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Immunization Rates at 14 weeks
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Immunization Rates at 14 Months
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Osayame Ekhaguere, MBBS, MPH, Children's Hospital of Philadelphia
- Director de estudio: Andrew Steenhoff, MBBCh, Children's Hospital of Philadelphia
- Director de estudio: Elizbeth Lowenthal, MD, MSCE, Children's Hospital of Philadelphia
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 15-012572
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .