- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04937049
EMAehealth Web Tool for Pregnancy and Puerperium: Effectiveness (EMAeHealthEF)
Effectiveness and Usability of a Web Tool for the Self-management of Women's Health Needs During Pregnancy, Childbirth and the Puerperium: EMAeHealth
연구 개요
상세 설명
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Isabel Artieta, PHD
- 전화번호: 867711 946006637
- 이메일: MARIAISABEL.ARTIETAPINEDO@osakidetza.eus
연구 연락처 백업
- 이름: Carmen Paz
- 전화번호: 946006637
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- pregnant woman
- week 8-10 of gestation
- to speak and understand Spanish language
Exclusion Criteria:
• not meeting any of the inclusion criteria
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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eHealth intervention to support Maternal Education
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간섭 없음: 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
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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
기간: 9 months.Measurements: at weeks 8th(baseline) and 37th of pregnancy, and at weeks 1th, 6th, and 16th postpartum
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline in Self-efficacy for labor and childbirth, measured with the Spanish version of Lowe's Childbirth Self-Efficacy Inventory scales.
기간: 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.
|
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Change from baseline in Self-efficacy for breasfeeding, measured with The Spanish version of the Breastfeeding Self-Efficacy Scale-Short Form
기간: 16 weeks. Measurements: at 1th(baseline), 6th and 16 weeks of portpartum period.
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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)
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16 weeks. Measurements: at 1th(baseline), 6th and 16 weeks of portpartum period.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Isabel Artieta, PHD, Osakidetza- Basque HS
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구 프로토콜
- 임상 연구 보고서(CSR)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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