- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
California
-
Los Angeles, California, États-Unis, 90095
- University of California, Los Angeles
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: MyFamilyPlan
Web-based health education tool (interactive self-assessment) provided for participant completion 7-10 days prior to a scheduled primary care visit.
|
Web-based preconception health education tool (interactive self-assessment) - to be completed by patient
|
|
Aucune intervention: Control
Standard preconception health education document provided for participant review 7-10 days prior to a scheduled primary care visit.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Proportion of women (intervention vs. control) reporting discussion of preconception health with provider at the primary care visit
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Numerical change in reported patient self-efficacy with respect to pregnancy planning before and after exposure to education tool (score range: 0-60)
Délai: 7-10 days after exposure to intervention
|
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)
|
7-10 days after exposure to intervention
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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
- IRB#15-001313
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