EMAehealth Web Tool for Pregnancy and Puerperium: Effectiveness

NCT ID: NCT04937049

Last Updated: 2021-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1080 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2023-07-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Pregnant Women Postpartum Period

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

EMAeHealth digital tool

Intervention Type OTHER

eHealth intervention to support Maternal Education

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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EMAeHealth digital tool

eHealth intervention to support Maternal Education

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* pregnant woman
* week 8-10 of gestation
* to speak and understand Spanish language
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Carlos III Health Institute

OTHER_GOV

Sponsor Role collaborator

Basque Health Service

OTHER_GOV

Sponsor Role collaborator

Biocruces Bizkaia Health Research Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isabel Artieta, PHD

Role: PRINCIPAL_INVESTIGATOR

Osakidetza- Basque HS

Central Contacts

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Isabel Artieta, PHD

Role: CONTACT

946006637 ext. 867711

Carmen Paz

Role: CONTACT

946006637

References

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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.

Reference Type RESULT
PMID: 15860162 (View on PubMed)

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.

Reference Type RESULT
PMID: 19941552 (View on PubMed)

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.

Reference Type RESULT
PMID: 21930270 (View on PubMed)

Espinosa Cifuentes M, Artieta-Pinedo I, Paz-Pascual C, Bully-Garay P, Garcia-Alvarez A; ema-Q Group. EMAeHealth, a digital tool for the self-management of women's health needs during pregnancy, childbirth and the puerperium: protocol for a hybrid effectiveness-implementation study. BMJ Open. 2022 Sep 1;12(9):e055031. doi: 10.1136/bmjopen-2021-055031.

Reference Type DERIVED
PMID: 36575817 (View on PubMed)

Other Identifiers

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EMAeHealth effectiveness

Identifier Type: -

Identifier Source: org_study_id

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