Family Caregivers' Experiences during the COVID-19 Pandemic: Qualitative Study.

Background: The COVID-19 pandemic imposed lockdown measures that affected caregiving. Understanding caregivers' context provides reveals their adaptive strategies to continue caring in this situation of uncertainty and isolation. Objective: To better understand the caregiving experiences of caregivers looking after dependent individuals living in the community during the pandemic. Design: Qualitative research, phenomenological approach. Setting: Primary healthcare centers in Madrid region (Spain). Participants: 21 family caregivers. Methods: Purposive and theoretical sampling was used to recruit caregivers across nurses from primary healthcare centers. Participants were interviewed using a semi-structured interview guide to explore the caring experience. Interview transcripts were evaluated using thematic analysis. Results: The findings were categorized into two themes: "Caregivers during lockdown-providing care in a time of adversity" and "Caregiving toward normality". The sub-themes identified were the re-structuring of before-care services and the introduction of new care approaches, managing the dependent person's health problems, looking after oneself, and dealing with adversity. To adapt to the new normal, strategies were put in place designed to recover confidence and trust, reincorporate assistance, and reconnect with others. Conclusions: Care intensified during the pandemic. Caregivers took on the task without assistance, focusing on preventing contagion and protecting themselves to be able to continue giving care.

'Learning by doing', a model for improving the promotion of healthy lifestyles by student nurses.

BACKGROUND: 'Learning by doing' is a learning model based on performing actions and gaining experience. The 'nursing process' is a systematic, rational method for providing nursing care. During their university education, nursing students need to acquire the ability to promote healthy lifestyles. OBJECTIVE: To determine the effectiveness of a learning strategy based on learning by doing and grounded in the use of the nursing process, on the lifestyle of nursing students. METHODS: This quasi-experimental intervention (before-after), performed over 2011-2022, involved 2300 nursing students at a university nursing school in Spain. The risk factors for chronic diseases-being a smoker, being overweight, or having high blood pressure-to which each student was exposed were recorded. Those positive for at least one risk factor selected companion students as 'support nursing students' who became responsible for designing an individualised care plan to reduce the risk(s) faced. To ensure the correct use of the nursing process, teachers approved and monitored the implementation of the care plans. Whether risk-reduction objectives were met was determined three months later. RESULTS: The students with risk factors largely improved their lifestyles (targets for reducing smoking/body weight were met) with the help of their supporting peers. CONCLUSIONS: The learning by doing method demonstrated its effectiveness, improving the lifestyle of at-risk students via the use of the nursing process.

Active legs: Impact of physical activity as an adjuvant treatment in the healing of venous ulcers in primary care: a RCT protocol study.

BACKGROUND: Venous ulcers usually present a torpid evolution with a negative impact on patients' quality of life. In primary care, they account for 2.5% of nursing consultations and their treatment represents high costs for national health systems. These patients usually have a low level of physical activity, with muscle pump dysfunction of the lower limbs, which may improve with increased physical activity. The purpose of this study is to analyse the effectiveness of a structured intervention involving physical activity and exercise (Active Legs) as an adjuvant treatment in improving healing of chronic venous ulcers at 3 months follow-up. METHODS: A randomized, multicentre clinical trial. A total of 224 individuals receiving primary nursing care with a diagnosis of venous ulcer, with a diameter of 1 cm or greater and an ankle-brachial index between 0.8 and 1.3, able to comply with the study requirements and consenting to participate, will be sequentially included (112 per group). Both groups will receive the standard treatment in primary care, with cleansing, debridement and healing in a moist environment together with multilayer compression therapy. The intervention group will also receive a structured educational intervention involving lower limb physical exercise and daily ambulation guidelines. The primary response variables will be complete healing -understood as complete and sustained epithelialisation for at least 2 weeks- and time to healing. The secondary variables will be degree of healing, ulcer area, quality of life, pain and variables related to the healing process, prognosis, and recurrences. Sociodemographic variables, adherence to treatment and satisfaction variables will also be recorded. Data will be collected at baseline, at 3 months and at 6 months follow-up. Survival analysis (Kaplan-Meier and Cox) will be performed to measure primary effectiveness. Intention-to-treat analysis. DISCUSSION: If the intervention is effective, a cost-effectiveness analysis could be conducted and implemented as an additional intervention in the usual venous ulcer treatment in primary care. TRIAL REGISTRATION: NCT04039789. [ https://ClinicalTrials.gov ]. 07/11/2019.

[Knowledge, use and opinion about written informed consent in primary healthcare nurses: CONOSER pilot project]. / Conocimiento, implementación y opinión acerca del consentimiento informado por escrito de las enfermeras de atención primaria: proyecto piloto CONOSER.

OBJECTIVE: To know the knowledge, implementation and opinion on informed consent of generalist nurses, specialists and primary care residents. DESIGN: Descriptive cross-sectional study using an online self-administered 'ad hoc' questionnaire. SETTING: Primary care nurses in Madrid, from November 2020 to March 2021. PARTICIPANTS: Sample of 114 nurses: 91 generalist, 20 specialists and 3 residents. MAIN MEASUREMENTS: Sociodemographics, knowledge, implementation and opinion. RESULTS: The response rate was 27.7%. As a general rule, 48.2% indicated that informed consent was collected verbally, as established by law, with differences being found between categories, this percentage being higher in specialists and residents (P=0.004), and within specialists in those who had obtained their speciality by internal resident nurse (IRN) (P<0.0001). In addition, specialists and residents were those who most identified the legal norm regulating informed consent (P<0.0001). In terms of implementation and opinion, all groups obtained similar results. DISCUSSION: There are no previous studies that have analysed these aspects of informed consent comparing the different categories. Studies from other healthcare and geographical areas show that nurses have greater knowledge, although the demand for specific training in bioethics and biolaw is greater in the nurses participating in this study. CONCLUSIONS: Nurses have adequate knowledge about informed consent, use it in clinical practice and have an appropriate conception of it, being higher in some items in specialist nurses IRN and in residents.

Sex differences in social support perceived by polymedicated older adults with multimorbidity. MULTIPAP study.

The beneficial effects of social support on morbidity, mortality, and quality of life are well known. Using the baseline data of the MULTIPAP study (n = 593), an observational, descriptive, cross-sectional study was carried out that analyzed the sex differences in the social support perceived by polymedicated adults aged 65 to 74 years with multimorbidity. The main outcome variable was social support measured through the Duke-UNC-11 Functional Social Support (DUFSS) questionnaire in its two dimensions (confident support and affective support). For both sexes, the perception of functional social support was correlated with being married or partnered and having a higher health-related quality of life utility index. In women, it was correlated with a higher level of education, living alone, and treatment adherence, and in men with higher monthly income, prescribed drugs and fewer diagnosed diseases.

Health-related quality of life in caregivers of community-dwelling individuals with disabilities or chronic conditions. A gender-differentiated analysis in a cross-sectional study.

BACKGROUND: Most care for people with chronic or disabling conditions living in the community is provided in the family context, and this care is traditionally provided by women. Providing informal care has a negative impact on caregivers' quality of life, which adds to existing health inequalities associated with gender. The aim of this study was to analyze factors associated with the health-related quality of life of caregivers and to determine their differences in a gender-differentiated analysis. METHODS: An observational, cross-sectional, multicenter study was conducted in primary healthcare. A total of 218 caregivers aged 65 years or older were included, all of whom assumed the primary responsibility for caring for people with disabling conditions for at least 6 months per year and agreed to participate in the CuidaCare study. The dependent variable was health-related quality of life, assessed with the EQ-5D. The explanatory variables tested were grouped into sociodemographic variables, subjective burden, caregiving role, social support and variables related to the dependent person. The associations between these variables and health-related quality of life were estimated by fitting robust linear regression models. Separate analyses were conducted for women and men. RESULTS: A total of 72.8% of the sample were women, and 27.2% were men. The mean score on the EQ-5D for female caregivers was 0.64 (0.31); for male caregivers, it was 0.79 (0.23). There were differences by gender in the frequency of reported problems in the dimensions of pain/comfort and anxiety/depression. The variables that were associated with quality of life also differed. Having a positive depression screening was negatively associated with quality of life for both genders: -0.31 points (95% CI: -0.47; -0.15) for female caregivers and -0.48 points (95% CI: -0.92; -0.03) for male caregivers. Perceived burden was associated with quality of life in the adjusted model for women (-0.12 points; 95% CI: -0.19; -0.06), and domestic help was associated in the adjusted model for male caregivers (-0.12 points; 95% CI: -0.19; -0.05). CONCLUSIONS: Gender differences are present in informal caregiving. The impact of providing informal care is different for male and female caregivers, and so are the factors that affect their perceived quality of life. It could be useful it incorporates a gender perspective in the design of nursing support interventions for caregivers to individualize care and improve the quality of life of caregivers. TRIAL REGISTRATION: NCT01478295 [ https://ClinicalTrials.gov ]. 23/11/2011.

Flu Vaccination Coverage and Predictors of Non-Vaccination in Military Health Corps Personnel 2016-2017 and 2019-2021.

(1) Background: Vaccination is the most effective intervention to control seasonal influenza morbidity and mortality. The present study aimed to determine the influenza vaccination coverage in the Military Health Corps personnel in the 2020−2021 season, as well as the time trend and the possible influence of the pandemic on coverage, in order to study the reasons that led to the non-vaccination of health professionals and to analyze adverse drug reactions (ADRs). (2) Methods: A descriptive, cross-sectional study was conducted from February to May 2021. All FAS CMS personnel were included. A self-administered questionnaire was sent by e-mail to the selected personnel. (3) Results: Vaccination coverage in the 2016−2017 season was 15.8% (n = 276), in the 2019−2020 season it was 17.41% (n = 424), and in the 2020−2021 season it was 24.22% (n = 590). The percentage of vaccinated men was higher than the percentage of women. In 2019 and 2020 the most vaccinated group was 31−40 years old. Lieutenants had the highest vaccination uptake in 2019 and 2020. The personnel with the highest uptake of vaccines were those in the specialty of nursing in each of 2016, 2019 and 2020, with >30 years of time worked in 2016. In terms of factors leading to refusal of vaccination, the most reported was "not considered a risk group" (23.0%), and the least reported was "avoidance of vaccine administration" (2.2%). Eighty individuals presented adverse reactions after vaccine administration (9.6%). (4) Conclusions: The rate of influenza vaccination among healthcare professionals was lower during the 2020 season compared to the previous season, but was expected to increase in the upcoming 2021 season.

Vaccine Coverage against Influenza and SARS-CoV-2 in Health Sciences Students during COVID-19 Pandemic in Spain.

Vaccination against influenza and SARS-CoV-2 is recommended in health sciences students to reduce the risk of acquiring these diseases and transmitting them to patients. The aim of the study was to evaluate how the pandemic influenced the modification of influenza vaccination coverage during the 2019/2020 and 2021/2022 campaigns and to analyze the vaccination coverage against SARS-CoV-2 in health sciences students. A cross-sectional study was conducted among students of the Faculty of Nursing, Physiotherapy and Podiatry of the Complutense University of Madrid. A questionnaire was administered in two stages, the first, Q1, before the start of the pandemic, where we analyzed influenza coverage during the 2019/2020 campaign and a second, Q2, 18 months after the start of the pandemic where we analyzed influenza coverage during the 2021/2022 campaign and coverage against SARS-CoV-2. A total of 1894 students (58.78% of the total of those enrolled) participated. Flu vaccination coverage increased from 26.7% in Q1 to 35.0% in Q2 (p < 0.05), being higher in the age group older than 21 years, who studied nursing, were in their fourth year and lived with people at risk. Vaccination coverage against SARS-CoV-2 was very high (97.8%), especially in students vaccinated against influenza. Coverage of the influenza vaccine in health sciences students increased from 2019-2020 to 2021-2022, being higher in the age group older than 21 years, who studied nursing, were in their first and fourth year and lived with people at risk. Coverage of the SARS-CoV-2 vaccine in health sciences students was very high, especially in those vaccinated against influenza.

The Attitude towards Vaccination of Health Sciences Students at a Spanish University Improved over the First 18 Months of the COVID-19 Pandemic.

It is important to know the attitudes of students of health sciences (SHSs) towards vaccination since they will be tomorrow's health professionals. Vaccination is a powerful tool in the fight against COVID-19. The aim of the present, cross-sectional study was to examine how the COVID-19 pandemic has influenced the attitude of SHSs towards vaccination. Data were collected in the form of a questionnaire from all students of nursing, physiotherapy and chiropody matriculated at a Madrid University for the academic year 2019/2020 (i.e., before the start of the pandemic [Q1]), and from all those matriculated for the year 2021/22 (i.e., c18 months after the pandemic was declared [Q2]). A multivariate analysis was performed to identify the influence of sex, degree being studied, course year and the time of answering (Q1 or Q2), on the dimensions Beliefs, Behaviours and General Attitude. Overall, 1894 questionnaires were returned (934 [49.3%] for Q1, and 960 [50.7%] for Q2), of which 70.5% were completed by students of nursing, 14% by students of physiotherapy and 15.4% by those studying chiropody. In Q2, the results for all three dimensions were significantly better (p < 0.05). The most important influencing factors were being a student of nursing, being in the final years of training (years 3 or 4), female gender and answering at the time of Q2. The results obtained are encouraging since student nurses (who showed Q1 and Q2 General Attitude scores of 3.34 and 3.47 (maximum possible 4), respectively [p < 0.05]) are the health professionals of tomorrow most likely to be involved in vaccination programmes.

Effectiveness of a group educational intervention - prolact - in primary care to promote exclusive breastfeeding: a cluster randomized clinical trial.

BACKGROUND: The rates of exclusive breastfeeding at 6 months in Spain are far from recommended by the World Health Organization, which is 50% by 2025. Evidence of the effectiveness of group interventions in late postpartum is limited. The objective of this study was to evaluate the effectiveness of the PROLACT group educational intervention for increasing the proportion of mother-child dyads with exclusive breastfeeding at 6 months compared to the usual practice in primary care. METHOD: Multicentre cluster randomized clinical trial. A total of 434 mother-child dyads who breastfed exclusively in the first 4 weeks of the children's life and agreed to participate were included. The main outcome was exclusive breastfeeding at 6 months. Secondary variables were type of breastfeeding, reasons for abandonment, degree of adherence and satisfaction with the intervention. To study the effectiveness, the difference in the proportions of dyads with exclusive breastfeeding at 6 months was calculated, and the relative risk (RR) and number needed to treat (NNT) were calculated with their 95% CIs. To study the factors associated with the maintenance of exclusive breastfeeding at 6 months, a multilevel logistic regression model was fitted. All analyses were performed to intention to treat. RESULTS: The percentage of dyads with exclusive breastfeeding at 6 months was 22.4% in the intervention group and 8.8% in the control group. PROLACT intervention obtained an RR =2.53 (95% CI: 1.54-4.15) and an NNT = 7 (95%CI: 5-14). The factors associated with exclusive breastfeeding at 6 months were the PROLACT intervention, OR = 3.51 (95%CI: 1.55-7.93); age > 39 years, OR = 2.79 (95%CI: 1.02-7.6); previous breastfeeding experience, OR = 2.61 (95%CI: 1.29-5.29); income between 500 and 833.33 €, OR = 3.52 (95%CI 1.47-8.47).); planning to start work before the infant was 6 months old, OR = 0.35 (0.19-0.63) . CONCLUSIONS: The PROLACT intervention in primary care is more effective than the usual practice for maintaining exclusive breastfeeding at 6 months, and can therefore be considered evidence-based practice for implementation in standard practice. TRIAL REGISTRATION: The trial was registered with ClinicalTrials.gov under code number NCT01869920 (03/06/2013).

Factors Associated With the Quality of Life of Patients With Venous Leg Ulcers in Primary Care: Cross-Sectional Study.

The presence of venous leg ulcers (VLU) is associated with emotional disorders in individuals who have conditions, such as depression, anxiety, and sleeping problems, which result in a reduced perceived quality of life by these individuals. The study aim was to describe the perceived quality of life and associated factors for individuals with VLU. We conducted a cross-sectional study in 22 primary care health centers with a sample of 93 individuals with VLU. The variables collected were the following: perceived quality of life measured with Spanish version of the Charing Cross Venous Ulcer Questionnaire (CCVUQ-e), ulcer severity measured with the RESVECH 2.0 Score, demographic variables, and those related to the healing process. The results showed a mean CCVUQ-e score of 47.4 ± 11.8 points (Mean ± SD), with the most affected dimension being the emotional status, followed by cosmesis, social interaction, and domestic activities. The mean RESVECH 2.0 score was 11.1 ± 3.7 points. An association was found between ulcer-related pain and poorer quality of life (P < .05, t test) and between erythema in perilesional skin and poorer quality life (P < .05, t test). The signs of infection and inflammation in the VLUs were as follows: increasing exudate, friable tissue, and biofilm-compatible tissue, which were associated with a poorer quality of life (P < .05, t test). The multivariate model was statistically significant and explained a variability of 26% in the CCVUQ-e score. This study confirms that wound severity, pain, and signs of infection in VLU decrease the perceived quality of life of individuals with these wounds.

Effectiveness of a home-based nursing support and cognitive restructuring intervention on the quality of life of family caregivers in primary care: A pragmatic cluster-randomized controlled trial.

BACKGROUND: Caregivers of patients with chronic conditions or disability experience fatigue, burden and poor health-related quality of life. There is evidence of the effectiveness of support interventions for decreasing this impact. However, little is known about the benefits of home-based nursing intervention in primary health care. OBJECTIVES: To evaluate the effectiveness of a home-based, nurse-led-intervention (CuidaCare) on the quality of life of caregivers of individuals with disabilities or chronic conditions living in the community, measured at 12-month follow-up. METHODS: A pragmatic, two-arm, cluster-randomized controlled trial with a 1-year follow-up period was performed between June 2013 and December 2015. Consecutive caregivers aged 65 years or older, all of whom assumed the primary responsibility of caring for people with disabling conditions for at least 6 months a year, were recruited from 22 primary health care centers. Subsequently, 11 centers were randomly assigned to usual care group, and 11 were assigned to the intervention group. The caregivers in the intervention group received the usual care and additional support (cognitive restructuring, health education and emotional support). The primary outcome was quality of life, assessed with the EQ-5D instrument (visual analog scale and utility index score); the secondary outcome variables were perception of burden, anxiety, and depression. Data were collected at baseline, at the end of the intervention, and at the 6- and 12-month follow-up visits. We analyzed the primary outcome as intention-to-treat, and missing data were added using the conditional mean single imputation method. RESULTS: A total of 224 caregivers were included in the study (102 in the intervention group and 122 in the usual care group). Generalized Estimating Equation models showed that the CuidaCare intervention was associated with a 5.46 point (95% CI: 2.57; 8.35) change in the quality of life, as measured with the visual analog scale adjusted for the rest of the variables at 12 months. It also produced an increase of 0.04 point (95% CI: 0.01; 0.07) in the utilities. No statistically significant differences were found between the two groups at 12 months with respect to the secondary outcomes. CONCLUSIONS: The findings suggest that incorporating a home-based, nurse-led-intervention for caregivers into primary care can improve the health-related quality of life of caregivers of patients with chronic or disabling conditions.

Prevalence and Correlates of Frailty in Community-Dwelling Older Adults with Chronic Pain: A Cross-Sectional Study.

BACKGROUND: Frailty is a frequent health condition in older adults of decreased functional reserve that leads to vulnerability to internal and external stressors. It has been associated with chronic pain, which is a common, costly and incapacitating condition in older adults. AIMS: To describe frailty status in a sample of community-dwelling older adults with chronic pain attending a primary health care centre. DESIGN: Cross-sectional investigation. PARTICIPANTS: Adults aged 65 years or older with chronic pain. METHODS: The Survey of Health, Ageing and Retirement in Europe Frailty Instrument (SHARE-FI) was used to assess frailty status and a visual analogue scale to assess pain intensity. Descriptive and analytical statistics were performed. RESULTS: Among 154 participants recruited, 20.1% were frail, 38.3% pre-frail and 41.6% robust. Women were more likely to be classified as frail or pre-frail (OR: 4.62, 95% CI: 2.23-9.59), as well as participants aged 75 years or older (OR: 3.41, 95% CI: 1.74-6.68) and participants reporting moderate and severe pain (OR: 4.20, 95% CI: 2.10-8.40). These results remained significant after adjustment. CONCLUSIONS: There is an association between frailty status and other variables such as older age, female gender and higher pain intensity.

A primary healthcare information intervention for communicating cardiovascular risk to patients with poorly controlled hypertension: The Education and Coronary Risk Evaluation (Educore) study-A pragmatic, cluster-randomized trial.

PURPOSE: Uncertainty exists regarding the best way to communicate cardiovascular risk (CVR) to patients, and it is unclear whether the comprehension and perception of CVR varies according to the format used. The aim of the present work was to determine whether a strategy designed for communicating CVR information to patients with poorly controlled high blood pressure (HBP), but with no background of cardiovascular disease, was more effective than usual care in the control of blood pressure (BP) over the course of a year. METHODS: A pragmatic, two-arm, cluster-randomized controlled trial was performed. Consecutive patients aged 40-65 years, all diagnosed with HBP in the last 12 months, and all of whom showed poor control of their condition (systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg), were recruited at 22 primary healthcare centres. Eleven centres were randomly assigned to the usual care arm, and 11 to the informative intervention arm (Educore arm). At the start of the study, the Educore arm subjects were shown the "low risk SCORE table", along with impacting images and information pamphlets encouraging the maintenance of good cardiovascular health. The main outcome variable measured was the control of HBP; the secondary outcome variables were SCORE table score, total plasma cholesterol concentration, use of tobacco, adherence to prescribed treatment, and quality of life. RESULTS: The study participants were 411 patients (185 in the Educore arm and 226 in the usual care arm). Multilevel logistic regression showed that, at 12 months, the Educore intervention achieved better control of HBP (OR = 1.57; 1.02 to 2.41). No statistically significant differences were seen between the two arms at 12 months with respect to the secondary outcomes. CONCLUSIONS: Compared to usual care, the Educore intervention was associated with better control of HBP after adjusting for age, baseline SBP and plasma cholesterol, at 12 months.

Establishing Technical Values for Nursing Diagnoses in Primary Healthcare.

PURPOSE: To establish technical values for nursing diagnoses in primary healthcare with which to weight the delivery of care based on criteria of complexity and relevance. METHODS: A three-phase cross-sectional descriptive study: (1) establishing and weighting of the assessment criteria of technical values, (2) scoring of the assessment criteria per diagnosis, and (3) assigning technical values. FINDINGS: Diagnoses were ordered on the scoring scale obtained and a technical value of 1 to 4 was assigned according to their quartile. CONCLUSIONS: Having a technical value for each nursing diagnosis helps to measure the diversity and complexity of care. IMPLICATIONS FOR NURSING PRACTICE: Technical values may contribute to improving nursing management indicators, as they incorporate a quantitative view into the assessment process.

OBJETIVO: Definir un valor técnico para los diagnósticos enfermeros en Atención Primaria que permita ponderar la prestación de cuidados en base a criterios de complejidad y relevancia. MÉTODOS: Estudio descriptivo transversal realizado en 3 fases: 1) definición y ponderación de los criterios de valoración del valor técnico, 2) puntuación de los criterios de valoración por diagnóstico, 3) asignación del valor técnico. RESULTADOS: Se ordenaron los diagnósticos en la escala de puntuación obtenida y se asignó un valor técnico del 1 al 4 en función del cuartil. CONCLUSIONES: Disponer de un valor técnico de cada diagnóstico enfermero permite dimensionar la diversidad y la complejidad de los cuidados. IMPLICACIONES: El valor técnico puede contribuir a mejorar los indicadores de gestión de servicios enfermeros al añadir una visión cuantitativa al proceso evaluativo. PALABRAS CLAVE: diagnóstico de enfermería; terminología normalizada de enfermería; Atención Primaria de salud; indicadores de calidad de la atención de salud; indicadores de gestión.

Effectiveness of an educational group intervention in primary healthcare for continued exclusive breast-feeding: PROLACT study.

BACKGROUND: The World Health Organization leads a global strategy to promote the initiation and maintenance of breast-feeding. Existing literature shows that education and supportive interventions, both for breast-feeding mothers as well as for healthcare professionals, can increase the proportion of women that use exclusive breast-feeding, however, more evidence is needed on the effectiveness of group interventions. METHODS: This study involves a community-based cluster randomised trial conducted at Primary Healthcare Centres in the Community of Madrid (Spain). The project aims to evaluate the effectiveness of an educational group intervention performed by primary healthcare professionals in increasing the proportion of mother-infant pairs using exclusive breastfeeding at six months compared to routine practice. The number of patients required will be 432 (216 in each arm). All mother-infant pairs using exclusive breastfeeding that seek care or information at healthcare centres will be included, as long as the infant is not older than four weeks, and the mother has used exclusive breastfeeding in the last 24 h and who gives consent to participate. The main response variable is mother-infant pairs using exclusive breast-feeding at six months. Main effectiveness will be analysed by comparing the proportion of mother-infant pairs using exclusive breast-feeding at six months between the intervention group and the control group. All statistical tests will be performed with intention-to-treat. The estimation will be adjusted using an explanatory logistic regression model. A survival analysis will be used to compare the two groups using the log-rank test to assess the effect of the intervention on the duration of breastfeeding. The control of potential confounding variables will be performed through the construction of Cox regression models. DISCUSSION: We must implement strategies with scientific evidence to improve the percentage of exclusive breast-feeding at six months in our environment as established by the WHO. Group education is an instrument used by professionals in Primary Care that favours the acquisition of skills and modification of already-acquired behaviour, all making it a potential method of choice to improve rates of exclusive breast-feeding in this period. TRIAL REGISTRATION: The trial was registered with ClinicalTrials.gov under code number NCT01869920 (Date of registration: June 3, 2013).

ECAMulticapa: Effectiveness of double-layered compression therapy for healing venous ulcers in primary care: a Study Protocol.

BACKGROUND: Chronic venous insufficiency, in its final stage can cause venous ulcers. Venous ulcers have a prevalence of 0.5 % to 0.8 % in the general population, and increases starting at 60 years of age. This condition often causes increased dependency in affected individuals, as well as a perceived reduced quality of life and family overload. Local Treating chronic venous ulcers has 2 components: topically healing the ulcer and controlling the venous insufficiency. There is evidence that compressive therapy favours the healing process of venous ulcers. The studies we have found suggest that the use of multilayer bandage systems is more effective than the use of bandages with a single component, these are mostly using in Spain. Multilayer compression bandages with 2 layers are equally effective in the healing process of chronic venous ulcers as 4-layer bandages and are better tolerated and preferenced by patients. More studies are needed to specifically compare the 2-layer bandages systems in the settings where these patients are usually treated. METHOD/DESIGN: Randomised, controlled, parallel, multicentre clinical trial, with 12 weeks of follow-up and blind evaluation of the response variable. The objective is to assess the efficacy of multilayer compression bandages (2 layers) compared with crepe bandages, based on the incidence of healed venous ulcers in individuals treated in primary care nursing consultations, at 12 weeks of follow-up. The study will include 216 individuals (108 per branch) with venous ulcers treated in primary care nursing consultations. The primary endpoint is complete healing at 12 weeks of follow-up. The secondary endpoints are the degree of healing (Resvech.2), quality of life (CCVUQ-e), adverse reactions related to the healing process. Prognosis and demographic variables are also recorder. Effectiveness analysis using Kaplan-Meier curves, a log-rank test and a Cox regression analysis. The analysis was performed by intention to treat. DISCUSSION: The study results can contribute to improving the care and quality of life of patients with venous ulcers, decreasing healing times and healthcare expenditure and contributing to the consistent treatment of these lesions. TRIAL REGISTRATION: This study has been recorded in the Clinical Trials.gov site with the code NCT02364921. 17 February 2015.

Effectiveness of a strategy that uses educational games to implement clinical practice guidelines among Spanish residents of family and community medicine (e-EDUCAGUIA project): a clinical trial by clusters.

BACKGROUND: Clinical practice guidelines (CPGs) have been developed with the aim of helping health professionals, patients, and caregivers make decisions about their health care, using the best available evidence. In many cases, incorporation of these recommendations into clinical practice also implies a need for changes in routine clinical practice. Using educational games as a strategy for implementing recommendations among health professionals has been demonstrated to be effective in some studies; however, evidence is still scarce. The primary objective of this study is to assess the effectiveness of a teaching strategy for the implementation of CPGs using educational games (e-learning EDUCAGUIA) to improve knowledge and skills related to clinical decision-making by residents in family medicine. The primary objective will be evaluated at 1 and 6 months after the intervention. The secondary objectives are to identify barriers and facilitators for the use of guidelines by residents of family medicine and to describe the educational strategies used by Spanish teaching units of family and community medicine to encourage implementation of CPGs. METHODS/DESIGN: We propose a multicenter clinical trial with randomized allocation by clusters of family and community medicine teaching units in Spain. The sample size will be 394 residents (197 in each group), with the teaching units as the randomization unit and the residents comprising the analysis unit. For the intervention, both groups will receive an initial 1-h session on clinical practice guideline use and the usual dissemination strategy by e-mail. The intervention group (e-learning EDUCAGUIA) strategy will consist of educational games with hypothetical clinical scenarios in a virtual environment. The primary outcome will be the score obtained by the residents on evaluation questionnaires for each clinical practice guideline. Other included variables will be the sociodemographic and training variables of the residents and the teaching unit characteristics. The statistical analysis will consist of a descriptive analysis of variables and a baseline comparison of both groups. For the primary outcome analysis, an average score comparison of hypothetical scenario questionnaires between the EDUCAGUIA intervention group and the control group will be performed at 1 and 6 months post-intervention, using 95 % confidence intervals. A linear multilevel regression will be used to adjust the model. DISCUSSION: The identification of effective teaching strategies will facilitate the incorporation of available knowledge into clinical practice that could eventually improve patient outcomes. The inclusion of information technologies as teaching tools permits greater learning autonomy and allows deeper instructor participation in the monitoring and supervision of residents. The long-term impact of this strategy is unknown; however, because it is aimed at professionals undergoing training and it addresses prevalent health problems, a small effect can be of great relevance. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02210442 .

CuidaCare: effectiveness of a nursing intervention on the quality of life's caregiver: cluster-randomized clinical trial.

BACKGROUND: In Spain, family is the main source of care for dependent people. Numerous studies suggest that providing informal (unpaid) care during a prolonged period of time results in a morbidity-generating burden. Caregivers constitute a high-risk group that experiences elevated stress levels, which reduce their quality of life.Different strategies have been proposed to improve management of this phenomenon in order to minimize its impact, but definitive conclusions regarding their effectiveness are lacking. METHODS/DESIGN: A community clinical trial is proposed, with a 1-year follow-up period, that is multicentric, controlled, parallel, and with randomized allocation of clusters in 20 health care centers within the Community of Madrid. The study's objective is to evaluate the effectiveness of a standard care intervention in primary health care (intervention CuidaCare) to improve the quality of life of the caregivers, measured at 0, 6, and 12 months after the intervention.One hundred and forty two subjects (71 from each group) ≥65 years, identified by the nurse as the main caregivers, and who provide consent to participate in the study will be included.The main outcome variable will be perceived quality of life as measured by the Visual Analogue Scale (VAS) of EuroQol-5D (EQ-5D). The secondary outcome variables will be EQ-5D Dimensions, EQ-5D Index, nursing diagnosis, and Zarit's test. Prognostic variables will be recorded for the dependent patient and the caregiver.The principle analysis will be done by comparing the average change in EQ-5D VAS value before and after intervention between the two groups. All statistical tests will be performed as intention-to-treat. Prognostic factors' estimates will be adjusted by mixed-effects regression models. Possible confounding or effect-modifying factors will be taken into account. DISCUSSION: Assistance for the caregiver should be integrated into primary care services. In order to do so, incorporating standard, effective interventions with relevant outcome variables such as quality of life is necessary. Community care nurses are at a privileged position to develop interventions like the proposed one. TRIAL REGISTRATION: This trial has been registered in ClinicalTrials.gov under code number NCT 01478295.