EMAehealth Web Tool for Pregnancy and Puerperium: Effectiveness

NCT04937049 | Unknown

• 1 other identifier: EMAeHealth effectiveness
• Study Type: interventional
• Target: 1,080
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Pregnant Women; Postpartum Period

Keywords

women; pregnancy; puerperium; eHealth; Antenatal Education; Health needs; Web tool

Outcome Measures

Primary Outcomes (1)

• 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

  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

  9 months.Measurements: at weeks 8th(baseline) and 37th of pregnancy, and at weeks 1th, 6th, and 16th postpartum

Secondary Outcomes (2)

• Change from baseline in Self-efficacy for labor and childbirth, measured with the Spanish version of Lowe's Childbirth Self-Efficacy Inventory scales.

  29 weeks. Measurements alt 8th(baseline) and 37th of pregnancy.

• Change from baseline in Self-efficacy for breasfeeding, measured with The Spanish version of the Breastfeeding Self-Efficacy Scale-Short Form

  16 weeks. Measurements: at 1th(baseline), 6th and 16 weeks of portpartum period.

Study Arms (2)

EMAeHealth digital tool

EXPERIMENTAL

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.

Other: EMAeHealth digital tool

No EMAeHealth digital tool

NO INTERVENTION

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

Interventions

EMAeHealth digital tool OTHER

eHealth intervention to support Maternal Education

EMAeHealth digital tool

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Biobizkaia Health Research Institute: lead
• Carlos III Health Institute: collaborator
• Basque Health Service: collaborator

Related Publications (4)

• 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.

  PMID: 15860162 RESULT

• 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.

  PMID: 19941552 RESULT

• 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.

  PMID: 21930270 RESULT

• 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.

  PMID: 36575817 DERIVED

Study Officials

• Isabel Artieta, PHD

  Osakidetza- Basque HS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabel Artieta, PHD

CONTACT

946006637; MARIAISABEL.ARTIETAPINEDO@osakidetza.eus

Carmen Paz

CONTACT

946006637

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 23, 2021
• Study Start: January 10, 2022
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: June 23, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 2023-2024
• Access Criteria: 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 )