EMAehealth Web Tool for Pregnancy and Puerperium: Effectiveness (EMAeHealthEF)
22 de junho de 2021 atualizado por: 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).
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
1080
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Isabel Artieta, PHD
- Número de telefone: 867711 946006637
- E-mail: MARIAISABEL.ARTIETAPINEDO@osakidetza.eus
Estude backup de contato
- Nome: Carmen Paz
- Número de telefone: 946006637
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- pregnant woman
- week 8-10 of gestation
- to speak and understand Spanish language
Exclusion Criteria:
• not meeting any of the inclusion criteria
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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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.
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Isabel Artieta, PHD, Osakidetza- Basque HS
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Antecipado)
10 de janeiro de 2022
Conclusão Primária (Antecipado)
1 de junho de 2023
Conclusão do estudo (Antecipado)
1 de julho de 2023
Datas de inscrição no estudo
Enviado pela primeira vez
11 de junho de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de junho de 2021
Primeira postagem (Real)
23 de junho de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
23 de junho de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
22 de junho de 2021
Última verificação
1 de junho de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- EMAeHealth effectiveness
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Sim
Descrição do plano 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 )
Prazo de Compartilhamento de IPD
2023-2024
Critérios de acesso de compartilhamento 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 )
Tipo de informação de suporte de compartilhamento de IPD
- Protocolo de estudo
- Relatório de Estudo Clínico (CSR)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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