EMAehealth Web Tool for Pregnancy and Puerperium: Effectiveness (EMAeHealthEF)

Biocruces Bizkaia

Status: Unknown

Conditions: Pregnant Women; Postpartum Period

Treatments: Other: EMAeHealth digital tool

Study type: Interventional

Funder types: Other

Identifiers

NCT04937049

EMAeHealth effectiveness

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 1,080 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• pregnant woman
• week 8-10 of gestation
• to speak and understand Spanish language

Exclusion criteria

• not meeting any of the inclusion criteria

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,080 participants in 2 patient groups

EMAeHealth digital tool

Experimental group

Description:

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.

Treatment:

Other: EMAeHealth digital tool

No EMAeHealth digital tool

No Intervention group

Description:

Usual care. This group, like experimental group, receives the usual care, which includes traditional maternal education, but does not receive the EMAeHealth intervention