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

2021年6月22日 更新者：Biocruces Bizkaia Health Research Institute

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).

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (予想される)

1080

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

  • 名前：Carmen Paz
  • 電話番号：946006637

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

説明

Inclusion Criteria:

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

Exclusion Criteria:

• not meeting any of the inclusion criteria

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：ヘルスサービス研究
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
他の：EMAeHealth digital tool
eHealth intervention to support Maternal Education
介入なし：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

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
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
時間枠：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
9 months.Measurements: at weeks 8th(baseline) and 37th of pregnancy, and at weeks 1th, 6th, and 16th postpartum

二次結果の測定

結果測定
メジャーの説明
時間枠
Change from baseline in Self-efficacy for labor and childbirth, measured with the Spanish version of Lowe's Childbirth Self-Efficacy Inventory scales.
時間枠：29 weeks. Measurements alt 8th(baseline) and 37th of pregnancy.
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)
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
時間枠：16 weeks. Measurements: at 1th(baseline), 6th and 16 weeks of portpartum period.
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)
16 weeks. Measurements: at 1th(baseline), 6th and 16 weeks of portpartum period.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Biocruces Bizkaia Health Research Institute

協力者

Carlos III Health Institute
Basque Health Service

捜査官

  • 主任研究者：Isabel Artieta, PHD、Osakidetza- Basque HS

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (予想される)

2022年1月10日

一次修了 (予想される)

2023年6月1日

研究の完了 (予想される)

2023年7月1日

試験登録日

最初に提出

2021年6月11日

QC基準を満たした最初の提出物

2021年6月22日

最初の投稿 (実際)

2021年6月23日

学習記録の更新

投稿された最後の更新 (実際)

2021年6月23日

QC基準を満たした最後の更新が送信されました

2021年6月22日

最終確認日

2021年6月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • EMAeHealth effectiveness

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 )

IPD 共有時間枠

2023-2024

IPD 共有アクセス基準

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 )

IPD 共有サポート情報タイプ

  • 研究プロトコル
  • 臨床試験報告書（CSR）

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

EMAeHealth digital toolの臨床試験

類似の治験を検索

スポンサーと協力者

医学的状態

薬物療法

CROs by country

CROs in Kyrgyzstan

条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所

3
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