Characterization model of the post COVID-19 condition based on immunological, biochemical, and cytokine markers.

Post-coronavirus disease condition (PCC) continues to affect many people globally, yet there remains a lack of diagnostic biomarkers to distinguish PCC from those recovered from acute COVID-19. This study compared biomarkers between two age- and gender-matched groups: PCC individuals and those recovered within three months of acute COVID-19 in 2020 (n = 85 each). Biomarkers were assessed 12-24 months after initial diagnosis, examining biochemical profiles, blood cell counts, coagulation status, antibody serology, lymphocyte populations, and cytokine levels. PCC individuals exhibited significant alterations in 49 of 167 markers, including K+ levels, αGAD antibodies, antithrombin III, insulin-like growth factor-binding protein 3 (IGFBP3), and interleukin-10 (IL-10). A panel of αGAD, IL-10, potassium levels, and CD16brightCD56- cell presence distinguished PCC individuals from recovered patients with >88% accuracy and <92% precision.

Effectiveness of an online multimodal rehabilitation program in long COVID patients: a randomized clinical trial.

BACKGROUND: Digital interventions are expected to facilitate the treatment of patients suffering from Long COVID. This trial assesses the effectiveness of a multimodal rehabilitation program -comprising both online and synchronous components- in managing the characteristic symptoms of Long COVID and, consequently, in improving quality of life. It also aims to identify which changes in measured variables from baseline (T0) to post-intervention (T1) predict an improvement in quality of life. METHODS: A blind randomized controlled trial was conducted with two parallel groups: (1) the control group, which received usual treatment from the primary care physician and (2) the intervention group, which received usual treatment in addition to an online multimodal rehabilitation program. The data were collected at two time points: prior to the start of the intervention and three months after it. The main outcome variable was quality of life, encompassing both mental health and physical health-related quality of life. Sociodemographic and clinical variables were collected as secondary variables. RESULTS: A total of 134 participants (age 48.97 ± 7.64; 84.33% female) were included and randomized into the control group (67 participants) and the intervention group (67 participants). Comparative analyses conducted before and after the intervention showed a significant improvement in the mental health-related quality of life of the participants who received the intervention, with a mean increase of 1.98 points (p < 0.05). Linear regression analyses revealed that both received the intervention (b = 3.193; p < 0.05) and an increased self-efficacy (b = 0.298; p < 0.05) were predictors of greater improvement in mental health-related quality of life.

Sex differences in formal recommendation of assets for health (social prescribing) in Aragon.

BACKGROUND: In primary health care, social prescribing is an important tool which is gaining popularity. It is being studied significantly, however there is not enough evidence about different related issues. The aim of this study is to analyse the differences by sex in the application of a social prescription protocol in Primary Care. METHODS: This is a cross-sectional study carried out with data from the Electronic Health Record between September 2018 and March 2021. Descriptive, bivariate and multivariate analyses of data from 2,109 records of Social Prescription protocol in primary health care centers located in Aragón in northern Spain (Europe) were performed using Jamovi Statistics software (version 2.3.28). The comparisons by sex were carried out using a Mann-Whitney U or chi-squared test to analyse differences. RESULTS: The protocol was used correctly 1,482 times, where it was applied more in females (74.8% female vs. 25.2% male). The median age in females was higher than males (female 72 vs. males 70; p = 0.003). There were significant differences by sex in several aspects to strengthen with the social prescribing, physical, emotional and relational skills. Most females and males regularly attended the recommended asset and there were significant differences in the group that never attended. Mean satisfaction was statistically different, with 4.74 points out of 5 for females and 4.86/5 for males (p = 0.010). It can be observed that older females in rural areas (OR = 34.15), whose social prescription acts on Emotional Skills and Relational and Social Skills (OR = 6.10-8.23), with good prior self-care and greater participant satisfaction (OR = 8.96), have greater chance of improving their health. CONCLUSIONS: Some results showed sex differences in the use and outcomes of formal asset recommendation. However, further research is needed to assess the relationship between social prescription, sex and gender and their implications.

Exploring personal aptitudes and personality traits that, together with social determinants, shape health behaviors and conduct: a thematic analysis based on the Capability, Opportunity, Motivation and Behavior (COM-B) change system.

Introduction: Effective implementation of strategies to promote health and prevent noncommunicable illnesses requires a profound understanding of the interaction between the individual and society. This study brings to health research the consideration of psychosocial factors that influence the maintenance and change of health behaviors and conduct. From a primary care perspective, it is crucial to propose a biopsychosocial approach for the development of health promotion and self-care programs that embrace personal aptitudes as a relevant individual aspect. Objectives: To explore experiences related to personal aptitudes and personality traits that influence health behaviors and conduct, taking into account the social determinants of health, through a thematic analysis based on the capability-opportunity-motivation and behavior (COM-B) system. Methods and analysis: This qualitative research is carried out from a descriptive phenomenological perspective, based on 17 focus groups in which 156 people participated. Inductive and deductive analysis techniques were used following Lincoln and Guba's criteria of methodological rigor. In addition to 7 different triangulations of analysts, 6 main categories were identified based on the COM-B system: psychological capacity, physical capacity, physical opportunity, social opportunity, reflective motivation, and automatic motivation. The importance of considering these factors to promote healthy behaviors was stressed. Discussion: This study examined how personal experiences related personal aptitudes and personality traits influence health behaviors and conduct in Spain. It was found that personality traits such as health literacy, self-efficacy, activation, and self-determination can influence the adoption of healthy behaviors. Likewise, the need for control, overthinking, and ambivalence made it impossible. Furthermore, social determinants of health and interpersonal relationships also play an important role. Trial registration: ClinicalTrials.gov, NCT04386135. Registered on April 30, 2020.

Use of health services and medication use, new comorbidities, and mortality in patients with chronic diseases who did not contract COVID-19 during the first year of the pandemic: a retrospective study and comparison by sex.

BACKGROUND: The restrictions introduced to stop the spread of the COVID-19 virus have also had a direct impact on people with chronic diseases and especially on diseases to which lifestyles are relevant in their control and management, such as diabetes, hypertension, chronic obstructive pulmonary disease (COPD), etc. The purpose of this paper is to conduct a longitudinal analysis of new comorbidities, mortality, medication use, and the use of health resources in patients with chronic diseases who did not contract COVID-19, comparing the six months before the strict lockdown to the 12 months following the end of the strict lockdown. METHOD: An observational real world data pre-post study of 668,974 people was undertaken. The patients studied were over 16 years of age, had been receiving care from the Aragon Health Service (Northeastern Spain), were diagnosed with one or more chronic diseases, and had not contracted COVID-19. Sociodemographic, comorbidity, pharmacological and health resource use variables were collected during the six months before the onset of the lockdown and during the six and 12 months following the end of the lockdown. The comparisons by sex were carried out using a Student T-test or chi-squared test to analyse differences. RESULTS: Dyslipidaemia (42.1%) followed by hypertension (35.1%) and anxiety and depression (34.6%) were the most prevalent chronic diseases among the study population. 78.% of patients had between one and four chronic illnesses. There was a decrease in new diagnoses of other chronic comorbidities in this population and a decrease in medications prescribed and the use of health services.  Although women received more diagnoses of chronic diseases, the number of medications dispensed was lower, but the use of health services was higher. These figures were maintained throughout the pandemic. CONCLUSION: Our results suggest an underdiagnosis of new chronic comorbidities and a decrease in mortality rates from causes unrelated to COVID-19 due to the closure of health centres in Aragón (Spain) during the lockdown. This trend was exacerbated in women. The underdiagnosis of new chronic comorbidities during confinement can cause the disease to worsen, with the consequent increase in symptoms and the worsening of chronic pathologies in patients with a severe evolution.

Functionality, physical activity, fatigue and quality of life in patients with acute COVID-19 and Long COVID infection.

A prominent feature of COVID-19, both in the short and long term, is the reduction in quality of life (QoL) due to low functionality scores and the presence of fatigue, which can hinder daily activities. The main objective of this study is to compare the functional status, level of physical activity, fatigue, and QoL of patients with Long COVID to other COVID-19 patients who did not develop persistent illness, and to determine whether there is a relationship between these variables and QoL. A cross-sectional study was conducted with 170 participants who had been infected with COVID-19 or had developed Long COVID. The main variables studied were functionality, physical activity, QoL and fatigue, measured using the PostCOVID-19 Functional Status Scale (PCFS), International Physical Activity Questionnaire (IPAQ), Short Form 12 (SF-12), and Fatigue Severity Scale (FSS). The main findings show a significant relationship (p < 0.001) between reduced functionality, lower physical activity levels, increased fatigue severity, and poorer QoL in Long COVID patients. Furthermore, these variables are also related to worse QoL, but only functional status predicts it. In conclusion, our results have shown highly significant correlations between the group with COVID-19 and Long COVID regarding functional status, level of physical activity, QoL, and fatigue.

Online multimodal rehabilitation programme to improve symptoms and quality of life for adults diagnosed with long COVID-19: a Randomised Clinical Trial protocol.

Background: Long COVID is a multisystemic condition which affects quality of life and implies a multidisciplinary treatment approach. There is still limited evidence on management techniques for this syndrome. "Telerehabilitation" could be an important tool when addressing the symptoms of this patients with the aim of increasing their quality of life. The purpose of this trial is to analyse the effectiveness of an online multimodal rehabilitation programme to improve the symptomatology of people with long COVID and their quality of life. Methods: A pragmatic randomised controlled trial will be performed with two parallel groups: (1) usual treatment by the primary care practitioner (Treatment as usual, TAU; control group) and (2) TAU plus the use of an online multimodal rehabilitation programme, including videoconferences and content published on a Moodle platform (intervention group). The data will be collected before and after the intervention. A follow-up will take place 3 months later. Discussion: There is still a lack of knowledge regarding the management of the symptoms of long COVID. This creates the need to add scientific evidence about the care of this disease, considering that multidisciplinary social and health teams can offer the necessary care so that these patients can recover their previous quality of life.Clinical trial registration: The protocol for this study was registered with the ISRCTN Registry [registration number: ISRCTN15414370] on 28 December 2022.

Depressive and Anxious Symptoms Increase with Problematic Technologies Use Among Adults: The Effects of Personal Factors Related to Health Behavior.

Background: Depression and anxiety disorders are a significant and growing health problem that has a significant impact on psychosocial functioning and quality of life. The onset and severity of mental health problems have been related to various biological, psychosocial, and behavioral variables. Purpose: The purpose of this study was to explore the association among the severity of depression and anxiety, problematic information and communications technology (ICT) use, and some related personal factors with health behavior among adults. It also analyzes the moderating role of personal factors in the relationship between the problematic use of ICT and anxiety and depression. Patients and Methods: Descriptive, bivariate, multivariate and moderation analyzes of data from 391 participants of 35-74 years old in primary health care centers located in Aragón (Spain) were performed between July 2021 and July 2022. The primary outcome was the severity of depressive and anxious symptoms as continuous variable. Results: Low sense of coherence (ß = -0.058; p = 0.043), low self-esteem (ß = -0.171; p=0.002), and low self-efficacy (ß = -0.122; p= 0.001), are predictors of having more severe depressive symptoms. Furthermore, low self-esteem (ß = -0.120; p= 0.012), low self-efficacy (ß = -0.092; p=0.004), and high problematic use of ICT (ß = 0.169; p = 0.001), are predictors of having more severe anxiety symptoms. Moderation analyzes were significant in the effect of self-efficacy (b = -0.040, p=0.001) and resilience (b = -0.024, p=0.033) on the relationship between problematic ICT use and anxiety. Conclusion: The problematic use of ICT and personal factors are related to depressive and anxiety symptoms. The interrelationship between problematic ICT use, personal factors, and depression needs to be further explored.

Role of personal aptitudes as determinants of incident morbidity, lifestyles, quality of life, use of the health services and mortality (DESVELA cohort): qualitative study protocol for a prospective cohort study in a hybrid analysis.

Introduction: Maintaining or acquiring healthier health-oriented behaviours and promoting physical and mental health amongst the Spanish population is a significant challenge for Primary Health Care. Although the role of personal aptitudes (characteristics of each individual) in influencing health behaviours is not yet clear, these factors, in conjunction with social determinants such as gender and social class, can create axes of social inequity that affect individuals' opportunities to engage in health-oriented behaviours. Additionally, lack of access to health-related resources and opportunities can further exacerbate the issue for individuals with healthy personal aptitudes. Therefore, it is crucial to investigate the relationship between personal aptitudes and health behaviours, as well as their impact on health equity. Objectives: This paper outlines the development, design and rationale of a descriptive qualitative study that explores in a novel way the views and experiences on the relationship between personal aptitudes (activation, health literacy and personality traits) and their perception of health, health-oriented behaviours, quality of life and current health status. Method and analysis: This qualitative research is carried out from a phenomenological perspective. Participants will be between 35 and 74 years of age, will be recruited in Primary Health Care Centres throughout Spain from a more extensive study called DESVELA Cohort. Theoretical sampling will be carried out. Data will be collected through video and audio recording of 16 focus groups in total, which are planned to be held in 8 different Autonomous Communities, and finally transcribed for a triangulated thematic analysis supported by the Atlas-ti program. Discussion: We consider it essential to understand the interaction between health-related behaviours as predictors of lifestyles in the population, so this study will delve into a subset of issues related to personality traits, activation and health literacy.Clinical trial registration: ClinicalTrials.gov, identifier NCT04386135.

Protocol for an observational cohort study on psychological, addictive, lifestyle behavior and highly prevalent affective disorders in primary health care adults.

Background: Depression and anxious symptoms are prevalent in the general population, and their onset and persistence may be linked to biological and psychosocial factors, many of which are lifestyle-related. The way we manage our care, physical and emotional health and/or discomfort is highly influenced by our own abilities, skills and attitudes despite life's circumstances. The main aim of this protocol to analyze the relationship between psychological constructs (self-efficacy, activation, health literacy, resilience, personality traits, sense of coherence, self-esteem), and the presence of affective-emotional problems (anxiety, depression) and addictions in primary health care. Methods: This is a protocol of a prospective longitudinal cohort study including people of 35-74 years old of Aragon primary health care centers (Spain). Three evaluations will be conducted: baseline evaluation, and follow-up assessments five and ten years after recruitment. The primary outcomes will be severity of depression, severity of anxiety, and addictive behaviors. A detailed set of secondary outcomes will be assessed across all three assessments. This will include psychosocial or personal factors on health behavior, social support, lifestyle patterns, quality of life, the use of health and social resources, and chronic comorbid pathology. Discussion: The analysis of the impact of psychological constructs and lifestyles on the mental health of people and communities will provide evidence that will make it possible to better address and prevent these prevalent problems and address their improvement from a more global and holistic perspective. The evaluation of psychological constructs should be incorporated into health services to improve people's ability their self-care, the level of knowledge of managing their disease and their physical, mental and social health. Clinical trial registration: https://www.isrctn.com/, identifier ISRCTN12820058.

Effectiveness of health literacy interventions on anxious and depressive symptomatology in primary health care: A systematic review and meta-analysis.

Background: Affective disorders are a debilitating and very prevalent problem throughout the world. Often these are associated with the onset of comorbidities or a consequence of chronic diseases. Anxiety and depression are associated with poor social and personal relationships, compromised health. We aimed to synthesize evidence from studies measuring the impact of a health literacy (HL) intervention on the improvement of affective disorders. Methods: For this systematic review and meta-analysis, we searched PubMed/MEDLINE, Embase, Web of Science, Ibecs, Cuiden, Scielo, Science Direct and Dialnet for exclusively randomized controlled trial studies (RCTs) published between 1 Jan 2011, and 31 May 2022. The search terms employed were "health literacy," "health knowledge," "anxiety," "anxiety disorder," "depression," "depressive disorder," and "adult." The risk of bias assessment was performed using the Cochrane Collaboration Revised Risk of Bias tool (RoB2). We conducted random-effects meta-analyses and explored heterogeneity using meta-regression and a stratified survey. Results: Of 2,863 citations found through the initial screening, 350 records were screened by the title and abstract for their themes and relevance. Finally, nine studies complied with the inclusion criteria for the meta-analysis. 66.66% of studies (n = 6) were rated as having a low risk of bias and 33.33% (n = 3) were judged to raise some concerns. The health literacy interventions were associated with -1.378 reduction in depression and anxiety questionnaires scores [95% CI (-1.850, -0.906)]. Low mood disorder scores are associated with better mental health and wellbeing. Conclusion: Our findings demonstrate that an HL intervention in relation to the symptoms associated with affective disorders improves the emotional state of patients in PHC, with a moderately positive effect in reducing depression and anxiety.

Improvement in the Management of Oral Anticoagulation in Patients with Atrial Fibrillation in Primary Health Care.

(1) Background: Evaluation and improvement of the management of patients with atrial fibrillation in treatment with oral anticoagulants from primary health care. (2) Methods: prospective quasi-experimental study, conducted on 385 patients assisted with Atrial Fibrillation (AF) at the Las Fuentes Norte Health Center, before and after the implementation of actions to improve oral anticoagulants management from October 2015 to July 2017. (3) Results: The ACO-ZAR I study revealed that the population with AF presents a global prevalence of 1.7%, an indication of oral anticoagulants of 92.1%, undertreatment of 24%, suboptimal control of vitamin K antagonists of 43%, use of antiaggregant as primary prevention of 13.42%, and primary health care monitoring of 34%. The implementation of activities aimed at improving the management of oral anticoagulants in the ACO-ZAR II study achieves a reduction in undertreatment up to 16%, in the use of antiaggregant up to 9%, and in suboptimal control up to 30%, as well as an increase in control from primary health care up to 69.2% and of the penetrance of direct oral anticoagulants up to 28%. (4) Conclusions: In conclusion, the application of activities aimed at optimizing the management of oral anticoagulants in health center patients allowed the improvement of risk assessment and registration, undertreatment, use of antiaggregant, suboptimal control of vitamin K antagonists, control by primary health care center, and the penetrance of direct oral anticoagulants.

The impact of the COVID-19 lockdown on depression sufferers: a qualitative study from the province of Zaragoza, Spain.

BACKGROUND AND PURPOSE: The impact of COVID-19 and its control measures have exacerbated existing mental health conditions. Although the deleterious effects of mental health problems are well known, fewer studies have examined the links between the Social Determinants of Health (SDHs) and depression. This study provides insights into the relationship between SDHs and depression during the first strict lockdown in Spain, which lasted for a period of 7 weeks. METHODS: Fifty-two structured interviews were conducted with people diagnosed with depression during June 2020 in the province of Zaragoza (Spain). Interviews were conducted by telephone due to lockdown constraints. Inductive thematic content analysis was used to explore, develop, and define emergent categories of analysis, which were mapped against the SDH framework. RESULTS: Listening to people's experiences of living with depression during lockdown provided insights into their concerns and coping strategies, which are greatly influenced by the conditions in which they live, their job and their age. Examples of these factors include access to and quality of physical spaces, including housing conditions and public spaces for socialising, social support, adverse working conditions which include caring responsibilities, and access to digital technologies and healthcare services. CONCLUSION: SDHs have played a fundamental role in shaping people's health and well-being during the COVID-19 pandemic, and this study has shown that they have a considerable effect on depression outcomes. Governments should consider implementing social welfare programs to tackle both psychosocial problems and material need during crisis situations.

Development and Validation of a Mobile Application as an Adjuvant Treatment for People Diagnosed with Long COVID-19: Protocol for a Co-Creation Study of a Health Asset and an Analysis of Its Effectiveness and Cost-Effectiveness.

OBJECTIVE: To analyse the overall effectiveness and cost-efficiency of a mobile application (APP) as a community health asset (HA) with recommendations and recovery exercises created bearing in mind the main symptoms presented by patients in order to improve their quality of life, as well as other secondary variables, such as the number and severity of ongoing symptoms, physical and cognitive functions, affective state, and sleep quality. METHODS: The first step was to design and develop the technologic community resource, the APP, following the steps involved in the process of recommending health assets (RHA). After this, a protocol of a randomised clinical trial for analysing its effectiveness and cost-efficiency as a HA was developed. The participants will be assigned to: (1st) usual treatment by the primary care practitioner (TAU), as a control group; and (2nd) TAU + use of the APP as a HA and adjuvant treatment in their recovery + three motivational interviews (MI), as an interventional group. An evaluation will be carried out at baseline with further assessments three and six months following the end of the intervention. DISCUSSION: Although research and care for these patients are still in their initial stages, it is necessary to equip patients and health care practitioners with tools to assist in their recovery. Furthermore, enhanced motivation can be achieved through telerehabilitation (TR).

Relationship between initial symptoms and the prognosis, sex, and demographic area of patients with COVID-19.

Background: A method of determining the initial symptoms and main prognostic identifiers for COVID-19 can be a key tool for physicians, especially primary care physicians. Therefore, the objective of this study was to examine the prognosis of patients with COVID-19 from two different demographic regions according to baseline and main symptoms, age, and sex. Methods: All individuals selected from both urban and rural health centers were over 18 years of age, had COVID-19 before 2 March 2021, and were followed up with a primary care physician. All patients included in this study were recruited in terms of sex, age at the time of infection, type of contact, baseline symptoms, primary and secondary symptomatology, emergency assistance, hospitalization, intensive care unit (ICU) admission, and death. Results: A total of 219 and 214 subjects were recruited from rural and urban health centers, respectively. Subjects with COVID-19 from rural areas were significantly older in age, with a higher proportion of men, and had significantly lower baseline and main symptoms than those from urban areas. In addition, the presence of both fever and dyspnea as the initial or main symptom is significantly associated with emergency assistance, hospitalization, and death, regardless of sex, age, and demographic area. This type of illness was reported to be significantly less frequent in the rural population than in the urban population. Conclusion: The presence of both fever and dyspnea as both initial and main symptoms is a poor prognostic factor for COVID-19, regardless of age, sex, and demographic areas. In addition, women reported lower levels of fever and dyspnea, requiring minimal emergency assistance and fewer hospitalization, and a lower rate of mortality than men. During a COVID-19 infection follow-up, subjects in rural areas seem to have less access to medical care than those in urban areas.

Effectiveness of a Multicomponent Intervention in Primary Care That Addresses Patients with Diabetes Mellitus with Two or More Unhealthy Habits, Such as Diet, Physical Activity or Smoking: Multicenter Randomized Cluster Trial (EIRA Study).

Introduction: We evaluated the effectiveness of an individual, group and community intervention to improve the glycemic control of patients with diabetes mellitus aged 45-75 years with two or three unhealthy life habits. As secondary endpoints, we evaluated the inverventions' effectiveness on adhering to Mediterranean diet, physical activity, sedentary lifestyle, smoking and quality of life. Method: A randomized clinical cluster (health centers) trial with two parallel groups in Spain from January 2016 to December 2019 was used. Patients with diabetes mellitus aged 45-75 years with two unhealthy life habits or more (smoking, not adhering to Mediterranean diet or little physical activity) participated. Centers were randomly assigned. The sample size was estimated to be 420 people for the main outcome variable. Educational intervention was done to improve adherence to Mediterranean diet, physical activity and smoking cessation by individual, group and community interventions for 12 months. Controls received the usual health care. The outcome variables were: HbA1c (main), the Mediterranean diet adherence score (MEDAS), the international diet quality index (DQI-I), the international physical activity questionnaire (IPAQ), sedentary lifestyle, smoking ≥1 cigarette/day and the EuroQuol questionnaire (EVA-EuroQol5D5L). Results: In total, 13 control centers (n = 356) and 12 intervention centers (n = 338) were included with similar baseline conditions. An analysis for intention-to-treat was done by applying multilevel mixed models fitted by basal values and the health center: the HbA1c adjusted mean difference = -0.09 (95% CI: -0.29-0.10), the DQI-I adjusted mean difference = 0.25 (95% CI: -0.32-0.82), the MEDAS adjusted mean difference = 0.45 (95% CI: 0.01-0.89), moderate/high physical activity OR = 1.09 (95% CI: 0.64-1.86), not living a sedentary lifestyle OR = 0.97 (95% CI: 0.55-1.73), no smoking OR = 0.61 (95% CI: 0.54-1.06), EVA adjusted mean difference = -1.26 (95% CI: -4.98-2.45). Conclusions: No statistically significant changes were found for either glycemic control or physical activity, sedentary lifestyle, smoking and quality of life. The multicomponent individual, group and community interventions only showed a statistically significant improvement in adhering to Mediterranean diet. Such innovative interventions need further research to demonstrate their effectiveness in patients with poor glycemic control.

[Baseline characteristics and quality of life in patients with Diabetes Mellitus included in the EIRA randomized clinical trial.] / Características basales y calidad de vida de los pacientes con Diabetes mellitus incluidos en el ensayo clínico aleatorizado EIRA.

OBJECTIVE: The EIRA study is a randomized clinical multicenter trial that aims to evaluate the effectiveness of a complex multi-risk intervention aimed at people aged 45-75 in Primary Care. The objectives of this work were to describe the baseline characteristics of patients with Diabetes Mellitus included in phase III of the EIRA study and analyze the relationship that different independent variables may have with the quality of life. METHODS: The data of all patients with Diabetes Mellitus that were included in phase III of EIRA study collected at baseline were analyzed. Patients with at least two or more of unhealthy lifestyles were selected: smoking, low adherence to the Mediterranean diet and/or low level of physical activity. The quality of life was measured with the EQ-5D-5L questionnaire. A descriptive and bivariate study was performed. The variables did not follow a normal distribution. Non-parametric statistical tests were used. For the multivariate analysis of the quality of life, automated linear regression was used with SPSS v19. RESULTS: 694 were patients included with Diabetes Mellitus (356 controls, 338 in intervention, without significant differences between both groups). Control: 37.64% women, age (median) 60 years. Intervention: 37.87% women, age (median) 60 years. Most prevalent risk behaviors in descending order: low adherence to the Mediterranean diet, low level of physical activity and smoking. The variables that significantly influenced quality of life were: GAD-7, work activity, HbA1c and CIDI. CONCLUSIONS: There are no significant differences motivated by the study design. The influence of mental health on the EQ-5D-5L is remarkable.

OBJETIVO: El estudio EIRA es un ensayo clínico aleatorizado multicéntrico que pretende evaluar la efectividad de una intervención compleja multirriesgo dirigida a personas de 45-75 años atendidas en Atención Primaria. Los objetivos de este trabajo fueron describir las características basales de los pacientes con Diabetes Mellitus incluidos en la fase III del estudio EIRA, y analizar la relación que puedan tener las diferentes variables independientes con la calidad de vida. METODOS: Se analizaron los datos recogidos al inicio del estudio de todos los pacientes con Diabetes Mellitus que se incluyeron en la fase III del estudio EIRA. Se seleccionaron pacientes con dos o más estilos de vida no saludables: tabaquismo, baja adherencia a dieta mediterránea y/o bajo nivel de actividad física. La calidad de vida se midió con el cuestionario EQ-5D-5L. Se realizó un estudio descriptivo y bivariante. Las variables no siguieron una distribución normal. Se utilizaron test estadísticos no paramétricos. Para identificar factores influyentes en la calidad de vida, se utilizó regresión lineal automatizada con SPSS v19. RESULTADOS: Se incluyeron 694 pacientes con Diabetes Mellitus (356 controles, 338 en intervención, sin diferencias significativas entre ambos grupos). Control: 37,64% mujeres, edad (mediana) 60 años. Intervención: 37,87% mujeres, edad (mediana) 60 años. Comportamientos de riesgo más prevalentes en orden descendente: baja adherencia a dieta mediterránea, bajo nivel de actividad física y tabaquismo. Las variables que influyeron significativamente en la calidad de vida fueron: GAD-7, actividad laboral, HbA1c y CIDI. CONCLUSIONES: No existen diferencias significativas motivadas por el diseño del estudio. Es destacable la influencia de la salud mental en el EQ-5D-5L.