ABSTRACT
INTRODUCTION: EHealth can help health service users take a more active role in decision-making and help health professionals guide the patient in this process. A digital tool has been designed to support maternal education (ME), and it is organised into four areas: (1) information, (2) communication, (3) health self-management and (4) clinical data. The main objective of the study is to evaluate the effectiveness of the EMAeHealth digital tool, and assess its usability and acceptability under routine conditions. METHODS AND ANALYSIS: Hybrid implementation-effectiveness design: (1) A cluster randomised, prospective, longitudinal, multicentre clinical trial to evaluate the effectiveness of EMAeHealth in (A) improving health-related quality of life (primary outcome), (B) improving self-efficacy for labour and childbirth and self-efficacy in breast feeding and (C) reducing the number of visits to the obstetric emergency services and health centre in situations of 'non-pathological pregnancy', 'false labour pains' and 'non-pathological puerperium'. The EMAeHealth intervention plus usual care will be compared with receiving only usual care, which includes traditional ME. N=1080 participants, 540 for each study arm. Two measurements will be made throughout the pregnancy and three in the first 16 weeks post partum. (2) A mixed-method study to evaluate the usability and acceptability of the tool, barriers and facilitators for its use, and implementation in our health system: focus groups (women, professionals and agents involved) and a quantitative analysis of implementation indicators. ANALYSIS: It will be carried out by intention to treat, using mixed models taking into account the hierarchical structure of the data and per protocol to evaluate the effectiveness of the express use of the digital tool. ETHICS AND DISSEMINATION: Clinical Research Ethics Committee of Euskadi, Spain, (Ref: PI2020044) approved this study. The results will be actively disseminated through manuscript publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT04937049.
Subject(s)
Self-Management , Humans , Female , Pregnancy , Quality of Life , Prospective Studies , Parturition , Postpartum Period , Women's Health , Randomized Controlled Trials as Topic , Multicenter Studies as TopicABSTRACT
OBJETIVO: Explorar las necesidades expresadas por las mujeres a lo largo del proceso de convertirse en madre y sus demandas relacionadas con la educación maternal. DISEÑO: Estudio cualitativo con grupos focales. EMPLAZAMIENTO: Área de salud de Bizkaia, Servicio Vasco de Salud/Osakidetza. PARTICIPANTES: Treinta mujeres seleccionadas de forma consecutiva por matronas de atención primaria de 6 centros de salud diferentes. MÉTODOS: Entre septiembre y noviembre de 2010 se formaron 4 grupos focales estratificados por situación socioeconómica y etapa del proceso (embarazo/puerperio). Para recoger las preocupaciones de las embarazadas, de las puérperas y su opinión sobre la educación maternal se siguió el método de análisis del contenido temático con el apoyo del software ATLAS. ti. RESULTADOS: El foco de preocupación de las mujeres va cambiando con el tiempo. Pasaba de la necesidad de confirmar que 'todo va bien' a necesitar más apoyo emocional y confianza para enfrentarse a sus miedos al parto y al cuidado de los hijos. Necesitaban mayor acompañamiento en el puerperio y menos presión con la lactancia materna. En cuanto a la educación maternal, demandaban un programa de educación perinatal en lugar de solo prenatal, más actualizado, con mayor participación de su pareja, más interactivo y flexible. CONCLUSIÓN: Las mujeres de nuestro entorno perciben necesidades similares a las de los países anglosajones, independientemente de las diferencias culturales. Parece claro la necesidad de rediseñar un programa de educación perinatal extenso, personalizado, dinámico, que empodere a las mujeres para gestionar su propia salud y la de su familia
OBJECTIVES. To assess women's perceptions of their needs during the process of becoming a mother and identify what they want from maternal education. DESIGN: Qualitative study with focus groups. SETTING: Bizkaia health region, Basque Health Service (Osakidetza), Spain. PARTICIPANTS: Thirty one women were recruited consecutively by midwives at six Osakidetza health centres. METHODS: Four sessions were held from September to November 2010 in Bizkaia (Spain), the four groups being stratified by socioeconomic status and stage of the process (pregnancy vs. postnatal period). To collate the information related to the various topics discussed, we used manifest content analysis that was facilitated by use of ATLAS. ti software. RESULTS: The focus of the women worries changes over time. In early pregnancy, women's main concern was for 'everything to go well'. As the pregnancy progressed, they needed more emotional support and wanted to feel confident and be self-reliant to face their fears of the birth and care for their child. They needed greater accompaniment in the puerperium and less pressure concerning breastfeeding. They also wanted an extended programme of perinatal rather than just antenatal education, which was more participatory and flexible and greater participation of their partner. CONCLUSION: Women have the same social and family networks needs, regardless of cultural differences between Anglo-Saxon and Southern European countries. We recommend an perinatal education to empower women to manage their own health and that of their family and link the health system with other networks of personal and social support for women
Subject(s)
Humans , Female , Pregnancy , Parenting/trends , Maternal Behavior/physiology , Prenatal Care/methods , Prenatal Care/organization & administration , Prenatal Education/methods , Prenatal Education/organization & administration , Health Services Needs and Demand/statistics & numerical data , Health Services Needs and Demand/trends , Needs Assessment/organization & administration , Needs Assessment/trends , 25783/methods , Primary Health Care/organization & administration , Data Analysis/methods , Postpartum Period/physiologyABSTRACT
OBJECTIVES: To assess women's perceptions of their needs during the process of becoming a mother and identify what they want from maternal education. DESIGN: Qualitative study with focus groups. SETTING: Bizkaia health region, Basque Health Service (Osakidetza), Spain. PARTICIPANTS: Thirty one women were recruited consecutively by midwives at six Osakidetza health centres. METHODS: Four sessions were held from September to November 2010 in Bizkaia (Spain), the four groups being stratified by socioeconomic status and stage of the process (pregnancy vs. postnatal period). To collate the information related to the various topics discussed, we used manifest content analysis that was facilitated by use of ATLAS.ti software. RESULTS: The focus of the women worries changes over time. In early pregnancy, women's main concern was for "everything to go well". As the pregnancy progressed, they needed more emotional support and wanted to feel confident and be self-reliant to face their fears of the birth and care for their child. They needed greater accompaniment in the puerperium and less pressure concerning breastfeeding. They also wanted an extended programme of perinatal rather than just antenatal education, which was more participatory and flexible and greater participation of their partner. CONCLUSION: Women have the same social and family networks needs, regardless of cultural differences between Anglo-Saxon and Southern European countries. We recommend an perinatal education to empower women to manage their own health and that of their family and link the health system with other networks of personal and social support for women.
Subject(s)
Attitude , Health Services Needs and Demand , Mothers/education , Prenatal Care , Female , Humans , Mothers/psychology , Qualitative Research , SpainABSTRACT
BACKGROUND: The 'predictD algorithm' provides an estimate of the level and profile of risk of the onset of major depression in primary care attendees. This gives us the opportunity to develop interventions to prevent depression in a personalized way. We aim to evaluate the effectiveness, cost-effectiveness and cost-utility of a new intervention, personalized and implemented by family physicians (FPs), to prevent the onset of episodes of major depression. METHODS/DESIGN: This is a multicenter randomized controlled trial (RCT), with cluster assignment by health center and two parallel arms. Two interventions will be applied by FPs, usual care versus the new intervention predictD-CCRT. The latter has four components: a training workshop for FPs; communicating the level and profile of risk of depression; building up a tailored bio-psycho-family-social intervention by FPs to prevent depression; offering a booklet to prevent depression; and activating and empowering patients. We will recruit a systematic random sample of 3286 non-depressed adult patients (1643 in each trial arm), nested in 140 FPs and 70 health centers from 7 Spanish cities. All patients will be evaluated at baseline, 6, 12 and 18 months. The level and profile of risk of depression will be communicated to patients by the FPs in the intervention practices at baseline, 6 and 12 months. Our primary outcome will be the cumulative incidence of major depression (measured by CIDI each 6 months) over 18 months of follow-up. Secondary outcomes will be health-related quality of life (SF-12 and EuroQol), and measurements of cost-effectiveness and cost-utility. The inferences will be made at patient level. We shall undertake an intention-to-treat effectiveness analysis and will handle missing data using multiple imputations. We will perform multi-level logistic regressions and will adjust for the probability of the onset of major depression at 12 months measured at baseline as well as for unbalanced variables if appropriate. The economic evaluation will be approached from two perspectives, societal and health system. DISCUSSION: To our knowledge, this will be the first RCT of universal primary prevention for depression in adults and the first to test a personalized intervention implemented by FPs. We discuss possible biases as well as other limitations. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01151982.
