Pregnant WomenEMAeHealthEFNCT04937049
EMAehealth Web Tool for Pregnancy and Puerperium: Effectiveness
A study testing EMAeHealth digital tool in people with Pregnant Women and Postpartum Period, run by Biobizkaia Health Research Institute.
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women, Postpartum Period
- What is being tested?
- EMAeHealth digital tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,080 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2022to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- pregnant woman
- week 8-10 of gestation
- to speak and understand Spanish language
Who cannot join
- not meeting any of the inclusion criteria
Trial locations and contacts
No sites are listed yet.
Carmen Paz contact
About this study
Official title: 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).
Read the detailed 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.
- Conditions
- Pregnant Women, Postpartum Period
- Being tested
- EMAeHealth digital tool
- Keywords
- women, pregnancy, puerperium, eHealth, Antenatal Education, Health needs, Web tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMAeHealth digital toolOther
eHealth intervention to support Maternal Education
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
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)
Measured: 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
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)
Measured: 16 weeks. Measurements: at 1th(baseline), 6th and 16 weeks of portpartum period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start10 Jan 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,080 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biobizkaia Health Research Institute
- Sponsor type
- Other government
- Collaborators
- Carlos III Health Institute, Basque Health Service
- Responsible party
- Sponsor
- Investigators
- Isabel Artieta, PHD, Principal investigator, Osakidetza- Basque HS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937049
- Sponsor's protocol ID
- EMAeHealth effectiveness
- Acronym
- EMAeHealthEF
- Status last verified
- Jun 2021
- First submitted
- 11 Jun 2021
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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 )
Publications
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.
PubMed 15860162Cunqueiro 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.
PubMed 19941552Oliver-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.
PubMed 21930270Espinosa 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.
PubMed 36575817
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Usability of a Web Tool for the Self-management of Women's Health Needs During Pregnancy, Childbirth and the Puerperium: EMAeHealth
- ClinicalTrials.gov ID
- NCT04937049
- Acronym / sponsor ID
- EMAeHealthEF / EMAeHealth effectiveness
- Conditions
- Pregnant Women, Postpartum Period
- Keywords
- women, pregnancy, puerperium, eHealth, Antenatal Education, Health needs, Web tool
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,080 participants (estimated)
- Lead sponsor
- Biobizkaia Health Research InstituteOther government
- Collaborators
- Carlos III Health Institute, Basque Health Service
- Study start
- 10 Jan 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMAeHealth digital tool | Experimental | Other: EMAeHealth digital toolThis 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. |
| 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- pregnant woman
- week 8-10 of gestation
- to speak and understand Spanish language
Key exclusion criteria (1 listed)
- not meeting any of the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMAeHealth digital tooleHealth intervention to support Maternal Education | Other | EMAeHealth digital tool |
Primary outcome
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
Time frame: 9 months.Measurements: at weeks 8th(baseline) and 37th of pregnancy, and at weeks 1th, 6th, and 16th postpartum
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
2 secondary outcomes
Change from baseline in Self-efficacy for labor and childbirth, measured with the Spanish version of Lowe's Childbirth Self-Efficacy Inventory scales.
Time frame: 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
Time frame: 16 weeks. Measurements: at 1th(baseline), 6th and 16 weeks of portpartum period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Results publication: PubMed 15860162Vilagut 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.
- Results publication: PubMed 19941552Cunqueiro 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.
- Results publication: PubMed 21930270Oliver-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.
- Derived from this study: PubMed 36575817Espinosa 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.
- Individual participant dataSharing planned: Yes. 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 )
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Paz contact
Isabel Artieta, PHD principal investigator
Osakidetza- Basque HS
Questions about this trial
What is this clinical trial studying?
A study testing EMAeHealth digital tool in people with Pregnant Women and Postpartum Period, run by Biobizkaia Health Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabel Artieta, PHD (946006637 ext. 867711, MARIAISABEL.ARTIETAPINEDO@osakidetza.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 9 months.Measurements: at weeks 8th(baseline) and 37th of pregnancy, and at weeks 1th, 6th, and 16th postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04937049, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.