EMAehealth Web Tool for Pregnancy and Puerperium: Effectiveness (EMAeHealthEF)
22 juin 2021 mis à jour par: Biocruces Bizkaia Health Research Institute
Effectiveness and Usability of a Web Tool for the Self-management of Women's Health Needs During Pregnancy, Childbirth and the Puerperium: EMAeHealth
The research team has designed, and will test, a web tool to support traditional Maternal Education (EM).
This tool is organized into 4 areas: 1) Information área; 2) Communication área (with peers and with professionals) 3) Self-management health area(instruments to check or reflect on their own health needs, as well as decision algorithms to detect the time of delivery and postpartum alarm symptoms); 4) Clinical data área (the woman can have her clinical data, include it and share it with other professionals) The objective of the study is to evaluate the clinical effectiveness of the EMAeHealth tool and also its implementation in the real world (its usability and acceptability, by women and professionals).
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
The usefulness of Maternal Education, as it is currently being developed, is being questioned due to the obvious changes that have arisen in access to information by mothers and fathers, and due to the changes that have occurred in childbirth care and in the attitude towards the process of motherhood and fatherhood.
There is no doubt, however, about the need to advise, care for and accompany couples in this stage of physical, family and social change.
To respond to these new needs, the evidence indicates that a digital format may be the most appropriate.
So, the research team has designed, and intends to test, a web tool, which is organized into 4 areas: 1) Information area: which will have information based on evidence, permanently updated by health services professionals ; 2) Communication area: allows women to contact other women in similar circumstances, through forums or conversations, or consult with professionals 3) Self-management health area : who have valid and reliable self-assessment instruments to check their own health needs, as well as decision algorithms to detect the time of delivery and postpartum alarm symptoms; 4) Clinical data area: in which the woman can collect clinical data, include the most recent and share it with other professionals if she so wishes.
The first area is open access, but not the other three, which require a password.
The objective is to evaluate the clinical effectiveness of the EMAeHealth tool, and also its implementation in the real world (its usability and acceptability, by women and professionals).
Methods: The research team propose a hybrid implementation-effectiveness design, which allows us to evaluate aspects related to the context while evaluating the clinical efficacy of the tool.
Discussion: A tool like the one described is of interest to women, to professionals and also to the health system.
Note- Clinical Trials submision correspond to clinical effectiveness part of the study.
Usability and acceptability is not included because it use qualitative methods.
Type d'étude
Interventionnel
Inscription (Anticipé)
1080
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Isabel Artieta, PHD
- Numéro de téléphone: 867711 946006637
- E-mail: MARIAISABEL.ARTIETAPINEDO@osakidetza.eus
Sauvegarde des contacts de l'étude
- Nom: Carmen Paz
- Numéro de téléphone: 946006637
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La description
Inclusion Criteria:
- pregnant woman
- week 8-10 of gestation
- to speak and understand Spanish language
Exclusion Criteria:
• not meeting any of the inclusion criteria
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: EMAeHealth digital tool
This team has designed a digital tool called EMAeHealth involving healthcare professionals.
It is organized into 4 areas: 1) an Information area, 2) a Communication area, 3) a Health Self-management area, 4) a Clinical data area, The tool is conceived as a complement that can reinforce maternal health education with resources that facilitate its accessibility, and rapid remote response, which will also improve its results.
It will be incorporated into the Osakidetza-Basque Health Service corporate Website.
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eHealth intervention to support Maternal Education
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Aucune intervention: No EMAeHealth digital tool
Usual care.
This group, like experimental group, receives the usual care, which includes traditional maternal education, but does not receive the EMAeHealth intervention
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The primary outcome is change from baseline in Health-related quality of life, measured with the Spanish version of the Short Form 36 Health Survey
Délai: 9 months.Measurements: at weeks 8th(baseline) and 37th of pregnancy, and at weeks 1th, 6th, and 16th postpartum
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The Spanish version of the SF-36 questionnaire assess the health-related quality of life.It´s made up of 8 domains, of which 4 are oriented towards physical aspects and another 4 towards mental aspects of health-related quality of life.
Two summaries are made of this physical and mental component, which explain between 80 and 85% of the variance.
The scores of the questionnaire are transformed on a scale from 0 to 100 points; the higher the score, the better the perception of health-related quality of life.
A difference of 5 points in the domain score, or between 2 and 3 points in the summary score is considered clinically relevant.
Vilagut G, 2005.
doi:10.1157/13074369
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9 months.Measurements: at weeks 8th(baseline) and 37th of pregnancy, and at weeks 1th, 6th, and 16th postpartum
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from baseline in Self-efficacy for labor and childbirth, measured with the Spanish version of Lowe's Childbirth Self-Efficacy Inventory scales.
Délai: 29 weeks. Measurements alt 8th(baseline) and 37th of pregnancy.
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The Childbirth Self-Efficacy Inventory (CBSEI) was developed by Nancy K Lowe in USA.The inventory is a self-report instrument that includes 62- items.
It is divided into four subscales measuring both outcome expectancies, i.e. what behavior they think would be useful during labour as well as self-efficacy expectancies, i.e. how they think they will be able to conduct themselves during labour.
The instrument measures these two dimensions of the self-efficacy construct, during both the first and the second stage of the labour process.
The responses are distributed by a 15-item scale for the outcome expectancy scales and a 16-item scale for the self-efficacy expectancy scales.
The response rates for all four scales range from 1 to 10; higher scores indicate a higher degree of childbirth self-efficacy.
(Cunqueiro MJ, et al Childbirth Self-Efficacy Inventory: psychometric testing of the Spanish version.
J Adv Nurs.
2009;65(12):2710-2718.
doi:10.1111/j.1365-2648.2009.05161.x)
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29 weeks. Measurements alt 8th(baseline) and 37th of pregnancy.
|
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Change from baseline in Self-efficacy for breasfeeding, measured with The Spanish version of the Breastfeeding Self-Efficacy Scale-Short Form
Délai: 16 weeks. Measurements: at 1th(baseline), 6th and 16 weeks of portpartum period.
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The Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) was developed to measure a mother's confidence in her ability to breastfeed her new infant.
The BSES-SF is a 14-item, unidimensional, self-report instrument developed to measure a mother's confidence in her ability to breastfeed.
All items are presented positively and anchored with a 5-point Likert-type scale where 1 indicates not at all confident and 5 indicates always confident.
Higher scores indicate higher levels of breastfeeding self-efficacy.
The translated Spanish version of BSES-SF scale can be considered a valid and reliable measure of maternal breastfeeding self-efficacy in Spain.
(Oliver-Roig A et al, Dennis The Spanish version of the Breastfeeding Self-Efficacy Scale-Short Form: reliability and validity assessment.
Int J Nurs Stud.
2012;49(2):169-173.
doi:10.1016/j.ijnurstu.2011.08.005)
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16 weeks. Measurements: at 1th(baseline), 6th and 16 weeks of portpartum period.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Isabel Artieta, PHD, Osakidetza- Basque HS
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Vilagut G, Ferrer M, Rajmil L, Rebollo P, Permanyer-Miralda G, Quintana JM, Santed R, Valderas JM, Ribera A, Domingo-Salvany A, Alonso J. [The Spanish version of the Short Form 36 Health Survey: a decade of experience and new developments]. Gac Sanit. 2005 Mar-Apr;19(2):135-50. doi: 10.1157/13074369. Spanish.
- Cunqueiro MJ, Comeche MI, Docampo D. Childbirth Self-Efficacy Inventory: psychometric testing of the Spanish version. J Adv Nurs. 2009 Dec;65(12):2710-8. doi: 10.1111/j.1365-2648.2009.05161.x.
- Oliver-Roig A, d'Anglade-Gonzalez ML, Garcia-Garcia B, Silva-Tubio JR, Richart-Martinez M, Dennis CL. The Spanish version of the Breastfeeding Self-Efficacy Scale-Short Form: reliability and validity assessment. Int J Nurs Stud. 2012 Feb;49(2):169-73. doi: 10.1016/j.ijnurstu.2011.08.005. Epub 2011 Sep 17.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Anticipé)
10 janvier 2022
Achèvement primaire (Anticipé)
1 juin 2023
Achèvement de l'étude (Anticipé)
1 juillet 2023
Dates d'inscription aux études
Première soumission
11 juin 2021
Première soumission répondant aux critères de contrôle qualité
22 juin 2021
Première publication (Réel)
23 juin 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
23 juin 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
22 juin 2021
Dernière vérification
1 juin 2021
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- EMAeHealth effectiveness
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Oui
Description du régime IPD
The protocol and the research results will be published.
Access to the data is feasible by requesting permission from the main researcher, Isabel Artieta
The protocol and the research results will be published.
Access to the data is feasible by requesting permission from the main researcher, Isabel Artieta
The protocol and the research results will be published. Access to data, ICF, etc. are available by requesting it from the main researcher, Isabel Artieta (MARIAISABEL.ARTIETAPINEDO@osakidetza.eus )
Délai de partage IPD
2023-2024
Critères d'accès au partage IPD
The protocol and the research results will be published.
Access to data, ICF, etc. are available by requesting it from the main researcher, Isabel Artieta (MARIAISABEL.ARTIETAPINEDO@osakidetza.eus )
Type d'informations de prise en charge du partage d'IPD
- Protocole d'étude
- Rapport d'étude clinique (CSR)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .