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临床试验/NCT04937049
NCT04937049Unknown不适用

Effectiveness and Usability of a Web Tool for the Self-management of Women's Health Needs During Pregnancy, Childbirth and the Puerperium: EMAeHealth

Biocruces Bizkaia Health Research Institute0 个研究点目标入组 1,080 人开始时间: 2022年1月10日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,080
主要终点
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

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

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

排除标准

  • not meeting any of the inclusion criteria

结局指标

主要结局

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

时间窗: 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

次要结局

  • 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.)
  • 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.)

研究者

发起方
Biocruces Bizkaia Health Research Institute
申办方类型
Other Gov
责任方
Sponsor

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