- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02529527
Web-based Preconception Health Education Tool
MyFamilyPlan: A Patient-Centered Web-based Preconception Health Education Tool
Strong evidence supports that preconception care, or care to optimize a woman's health health prior to pregnancy, can improve birth outcomes. Preconception health counseling covers a broad range of topics, including: desire for pregnancy, obstetric history, nutrition, vaccinations, sexual health, chronic disease, substance abuse, mental health and contraception. Despite calls from public health organizations and experts in the field for universal access to preconception care, most US women do not receive any health counseling to prepare for pregnancy. Given that approximately half of US pregnancies are unintended, it is critical that routine primary care serve as a venue for the provision of this important service. From a patient's perspective, improving preconception health involves many health behavior changes. As such, patient engagement and education regarding preconception health must be a primary focus. Several preconception health promotion tools have been developed for patients to date; few are truly patient-centered and even fewer have been rigorously evaluated.
This study presents MyFamilyPlan - a novel, web-based, patient centered preconception health education tool designed for women of reproductive age receiving primary care. MyFamilyPlan is truly innovative in two key ways:
- MyFamilyPlan is a web-based preconception health self-assessment. This will allow for the employment of skip logic to individualize the questionnaire and subsequent health recommendations for each patient.
- Recognizing that preconception care is relevant to all women "at risk" of pregnancy, MyFamilyPlan has been designed for utilization in a primary care setting.
This preconception health education tool will be tested using a randomized controlled design. This study will measure whether or not exposure to MyFamilyPlan promotes the discussion of preconception health issues in primary care encounters (primary outcome). It will also evaluate whether the intervention affects participant self-efficacy in planning a healthy pregnancy, and relevant health behaviors (secondary outcome). The study proposed here will improve the quality of evidence for preconception health education tools. Should it demonstrate effectiveness, it will also result in a new tool that could be made more widely available to promote preconception health.
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90095
- University of California, Los Angeles
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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:
- 18-45 years of age
- English-speaking
- Non-pregnant
- Capable of pregnancy (i.e., no previous hysterectomy or sterilization procedure)
- Scheduled primary care visit in health system in the upcoming 7-10 days
- Active email address
Exclusion Criteria;
- Currently pregnant
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: MyFamilyPlan
Web-based health education tool (interactive self-assessment) provided for participant completion 7-10 days prior to a scheduled primary care visit.
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Web-based preconception health education tool (interactive self-assessment) - to be completed by patient
|
|
Sin intervención: Control
Standard preconception health education document provided for participant review 7-10 days prior to a scheduled primary care visit.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Proportion of women (intervention vs. control) reporting discussion of preconception health with provider at the primary care visit
Periodo de tiempo: 7-10 days after exposure to intervention
|
Patient-reported discussion of preconception health with a provider at the primary care visit (measured by post-intervention patient survey: yes/no item)
|
7-10 days after exposure to intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Numerical change in reported patient self-efficacy with respect to pregnancy planning before and after exposure to education tool (score range: 0-60)
Periodo de tiempo: 7-10 days after exposure to intervention
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Change in self-efficacy score (patient-rated) after exposure to intervention or control (measured by change in 6-item validated Reproductive Health and Behaviors self-efficacy score between pre-intervention patient survey and post-intervention patient survey)
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7-10 days after exposure to intervention
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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
Otros números de identificación del estudio
- IRB#15-001313
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. .