Complex multiple risk intervention topromote healthy behaviours in peoplebetween 45 to 75 years attended inprimary health care (EIRA study): study protocol for a hybrid trial

Background:Health promotion is a key process of current health systems. Primary Health Care (PHC) is the idealsetting for health promotion but multifaceted barriers make its integration difficult in the usual care. The majority ofthe adult population engages two or more risk behaviours, that is why a multiple intervention might be moreeffective and efficient. The primary objectives are to evaluate the effectiveness, the cost-effectiveness andan implementation strategy of a complex multiple risk intervention to promote healthy behaviours in peoplebetween 45 to 75 years attended in PHC.Methods:This study is a cluster randomised controlled hybrid type 2 trial with two parallel groups comparing acomplex multiple risk behaviour intervention with usual care. It will be carried out in 26 PHC centres in Spain. Thestudy focuses on people between 45 and 75 years who carry out two or more of the following unhealthybehaviours: tobacco use, low adherence to the Mediterranean dietary pattern or insufficient physical activity level.The intervention is based on the Transtheoretical Model and it will be made by physicians and nurses in theroutine care of PHC practices according to the conceptual framework of the“5A’s”. It will have a maximum durationof 12 months and it will be carried out to three different levels (individual, group and community). Incremental costper quality-adjusted life year gained measured by the tariffs of the EuroQol-5D questionnaire will be estimated. Theimplementation strategy is based on the“Consolidated Framework for Implementation Research”, a set of discreteimplementation strategies and an evaluation framework. Discussion:EIRA study will determine the effectiveness and cost-effectiveness of a complex multiple riskintervention and will provide a better understanding of implementation processes of health promotioninterventions in PHC setting. It may contribute to increase knowledge about the individual and structural barriersthat affect implementation of these interventions and to quantify the contextual factors that moderate theeffectiveness of implementation

Low Resilience Was a Risk Factor of Mental Health Problems during the COVID-19 Pandemic but Not in Individuals Exposed to COVID-19: A Cohort Study in Spanish Adult General Population

Coronavirus; Resilience, Psychological; Mental HealthCoronavirus; Resiliencia psicológica; Salud mentalCoronavirus; Resiliència, psicològica; Salut MentalBackground: The aim is to analyze whether people with low resilience are at higher risk of mental health problems during the COVID-19 pandemic in Spanish adults. Methods: a longitudinal cohort study was carried out. Resilience was measured with the CD-RISC. Mental health problems that were assessed included: Major Depressive Episode (MDE), Generalized Anxiety Disorder (GAD), Suicidal Thoughts and Behaviors (STB), and Posttraumatic Stress Disorder (PTSD) symptoms. Results: we found statistically significant differences between groups and resilience scores in MDE [F (3; 48.40) = 19.55], GAD [F (3; 19.63) = 6.45] and STB [F (3; 111.74) = 31.94]. Multivariable analyses showed individuals with very low resilience were at a 5-fold risk of Incidence of MDE and a 4-fold risk of STB. Persistent group presented a 21-fold risk of MDE and 54-fold risk of STB. No evidence of higher risk was found for GAD. Individuals with low resilience and exposed to COVID-19 were not at higher risk. Individuals with low resilience were at higher risk of PTSD in general population [β(95% CI) = -3.25 (-3.969 to -2.54)], but not for individuals with COVID-19. Conclusions: in the general population, having low or very low resilience increases the risk of suffering MDE, STB, and PTSD, but not GAD during the COVID-19 pandemic, and not in the population with COVID-19

Health status, lifestyle habits, and perceived social support in long-term cancer survivors : a cross-sectional study

Altres ajuts: This study was funded by a research grant from the Instituto de Salud Carlos III Institute of Health at the Spanish Ministry of Economy and Competitiveness. This funding was applicable only to data collection and fees for conference attendance and publication. The project also received partial funds from the RedIAPP Preventive Activities and Health Promotion Network (RD12/0005; RD16/0007) for data collection by the coordinating researcher, from the Spanish Cancer League, Balearic Association (2012) for the translation of the manuscript, and from the Catalan Department of Health (SLT002/16/00/00112) for a data manager contract.To compare the presence of comorbidities and self-perceived health and social support between long-term cancer survivors and people without a history of cancer from a clinical trial examining the effects of a multiple risk behavior intervention. Of the 4259 people studied, 190 (4.46%) were cancer survivors. They had a mean ± SD age of 62.8 ± 7 years vs. 58.7 ± 8 years (P < 0.01) for non-cancer people and were more likely to be on long-term sick leave (11.9 vs. 3.5%, P < 0.001). No differences were observed for smoking, adherence to the Mediterranean diet, physical activity, obesity, or social support. Cancer survivors were more likely to have worse self-perceived health (OR 1.82; 95% CI 1.02-2.75), more comorbidities (OR 1.68; 95% CI 1.18-2.39), COPD (OR 2.17; 95% CI 1.25-3.78), and depression (OR 1.65; 95% CI 1.06-2.57). Older age and worse self-perceived health were independent predictors of survivorship in the adjusted analysis

Low Resilience Was a Risk Factor of Mental Health Problems during the COVID-19 Pandemic but Not in Individuals Exposed to COVID-19: A Cohort Study in Spanish Adult General Population

Background: The aim is to analyze whether people with low resilience are at higher risk of mental health problems during the COVID-19 pandemic in Spanish adults. Methods: a longitudinal cohort study was carried out. Resilience was measured with the CD-RISC. Mental health problems that were assessed included: Major Depressive Episode (MDE), Generalized Anxiety Disorder (GAD), Suicidal Thoughts and Behaviors (STB), and Posttraumatic Stress Disorder (PTSD) symptoms. Results: we found statistically significant differences between groups and resilience scores in MDE [F (3; 48.40) = 19.55], GAD [F (3; 19.63) = 6.45] and STB [F (3; 111.74) = 31.94]. Multivariable analyses showed individuals with very low resilience were at a 5-fold risk of Incidence of MDE and a 4-fold risk of STB. Persistent group presented a 21-fold risk of MDE and 54-fold risk of STB. No evidence of higher risk was found for GAD. Individuals with low resilience and exposed to COVID-19 were not at higher risk. Individuals with low resilience were at higher risk of PTSD in general population [β(95% CI) = −3.25 (−3.969 to −2.54)], but not for individuals with COVID-19. Conclusions: in the general population, having low or very low resilience increases the risk of suffering MDE, STB, and PTSD, but not GAD during the COVID-19 pandemic, and not in the population with COVID-19

Direct medical costs attributable to type 2 diabetes mellitus : a population-based study in Catalonia, Spain

We estimated healthcare costs associated with patients with type 2 diabetes compared with non-diabetic subjects in a population-based primary care database through a retrospective analysis of economic impact during 2011, including 126,811 patients with type 2 diabetes in Catalonia, Spain. Total annual costs included primary care visits, hospitalizations, referrals, diagnostic tests, selfmonitoring test strips, medication, and dialysis. For each patient, one control matched for age, gender and managing physician was randomly selected from a population database. The annual average cost per patient was €3110.1 and €1803.6 for diabetic and non-diabetic subjects, respectively (difference €1306.6; i.e., 72.4 % increased cost). The costs of hospitalizations were €1303.1 and €801.6 (62.0 % increase), and medication costs were €925.0 and €489.2 (89.1 % increase) in diabetic and non-diabetic subjects, respectively. In type 2 diabetic patients, hospitalizations and medications had the greatest impact on the overall cost (41.9 and 29.7 %, respectively), generating approximately 70 % of the difference between diabetic and non-diabetic subjects. Patients with poor glycaemic control (glycated haemoglobin [7 %; [53 mmol/mol) had average costs of €3296.5 versus €2848.5 for patients with good control. In the absence of macrovascular complications, average costs were €3008.1 for diabetic and €1612.4 for non-diabetic subjects, while its presence increased costs to €4814.6 and €3306.8, respectively. In conclusion, the estimated higher costs for type 2 diabetes patients compared with non-diabetic subjects are due mainly to hospitalizations and medications, and are higher among diabetic patients with poor glycaemic control and macrovascular complication

Multiple health behaviour change primary care intervention for smoking cessation, physical activity and healthy diet in adults 45 to 75 years old (EIRA study): a hybrid effectiveness-implementation cluster randomised trial

Health behaviour; Health promotion; Hybrid trialComportamiento de salud; Promoción de la salud; Prueba híbridaComportament de salut; promoció de la salut; Prova híbridaBackground This study aimed to evaluate the effectiveness of a) a Multiple Health Behaviour Change (MHBC) intervention on reducing smoking, increasing physical activity and adherence to a Mediterranean dietary pattern in people aged 45–75 years compared to usual care; and b) an implementation strategy. Methods A cluster randomised effectiveness-implementation hybrid trial-type 2 with two parallel groups was conducted in 25 Spanish Primary Health Care (PHC) centres (3062 participants): 12 centres (1481 participants) were randomised to the intervention and 13 (1581 participants) to the control group (usual care). The intervention was based on the Transtheoretical Model and focused on all target behaviours using individual, group and community approaches. PHC professionals made it during routine care. The implementation strategy was based on the Consolidated Framework for Implementation Research (CFIR). Data were analysed using generalised linear mixed models, accounting for clustering. A mixed-methods data analysis was used to evaluate implementation outcomes (adoption, acceptability, appropriateness, feasibility and fidelity) and determinants of implementation success. Results 14.5% of participants in the intervention group and 8.9% in the usual care group showed a positive change in two or all the target behaviours. Intervention was more effective in promoting dietary behaviour change (31.9% vs 21.4%). The overall adoption rate by professionals was 48.7%. Early and final appropriateness were perceived by professionals as moderate. Early acceptability was high, whereas final acceptability was only moderate. Initial and final acceptability as perceived by the participants was high, and appropriateness moderate. Consent and recruitment rates were 82.0% and 65.5%, respectively, intervention uptake was 89.5% and completion rate 74.7%. The global value of the percentage of approaches with fidelity ≥50% was 16.7%. Eight CFIR constructs distinguished between high and low implementation, five corresponding to the Inner Setting domain. Conclusions Compared to usual care, the EIRA intervention was more effective in promoting MHBC and dietary behaviour change. Implementation outcomes were satisfactory except for the fidelity to the planned intervention, which was low. The organisational and structural contexts of the centres proved to be significant determinants of implementation effectiveness

Effectiveness of an intensive E-mail based intervention in smoking cessation (TABATIC study) : study protocol for a randomized controlled trial

Background: Intensive interventions on smoking cessation increase abstinence rates. However, few electronic mail (E-mail) based intensive interventions have been tested in smokers and none in primary care (PC) setting. The aim of the present study is to evaluate the effectiveness of an intensive E-mail based intervention in smokers attending PC services. Methods/design: Randomized Controlled Multicentric Trial. Study population: 1060 smokers aged between 18-70 years from Catalonia, Salamanca and Aragón (Spain) who have and check regularly an E-mail account. Patients will be randomly assigned to control or intervention group. Intervention: Six phase intensive intervention with two face to face interviews and four automatically created and personal E-mail patients tracking, if needed other E-mail contacts will be made. Control group will receive a brief advice on smoking cessation. Outcome measures: Will be measured at 6 and 12 months after intervention: self reported continuous abstinence (confirmed by cooximetry), point prevalence abstinence, tobacco consumption, evolution of stage according to Prochaska and DiClemente's Stages of Change Model, length of visit, costs for the patient to access Primary Care Center. Statistical analysis: Descriptive and logistic and Poisson regression analysis under the intention to treat basis using SPSS v.17. Discussion: The proposed intervention is an E-mail based intensive intervention in smokers attending primary care. Positive results could be useful to demonstrate a higher percentage of short and long-term abstinence among smokers attended in PC in Spain who regularly use E-mail. Furthermore, this intervention could be helpful in all health services to help smokers to quit. Trial Registration: Clinical Trials.gov Identifier: NCT01494246

Effectiveness, cost-utility, and benefits of a multicomponent therapy to improve the quality of life of patients with fibromyalgia in primary care: A mixed methods study protocol

Introduction: Fibromyalgia (FM) is a chronic condition characterized by chronic pain, fatigue and loss of function which significantly impairs quality of life. Although treatment of FM remains disputed, some studies point at the efficacy of interdisciplinary therapy. This study aims to analyze the effectiveness, cost-utility and benefits of a multicomponent therapy on quality of life (main variable), functional impact, mood and pain in people suffering from FM that attend primary care centers (PCCs) of the Catalan Institute of Health (ICS). Methods and analysis: A 2-phase, mixed methods study has been designed following Medical Research Council guidance. Phase 1: Pragmatic randomized clinical trial with patients diagnosed with FM that attend one of the 11 PCCs of the ICS Gerència Territorial Terres de l'Ebre. We estimate a total sample of 336 patients. The control group will receive usual clinical care, while the multicomponent therapy group (MT group) will receive usual clinical care plus group therapy (consisting of health education, exercise and cognitive-behavioural therapy) during 12 weeks in 2-hourly weekly sessions. Analysis: the standardized mean response and the standardized effect size will be assessed at 3, 9, and 15 months after the beginning of the study using multiple linear regression models. Utility measurements will be used for the economic analysis. Phase 2: Qualitative socio constructivist study to evaluate the intervention according to the results obtained and the opinions and experiences of participants (patients and professionals). We will use theoretical sampling, with 2 discussion groups of participants in the multicomponent therapy and 2 discussion groups of professionals of different PCCs. A thematic content analysis will be carried out. Ethics and dissemination: This study protocol has been approved by the Clinical Research Ethics Committee of the Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (code P18/068). Articles will be published in international, peer-reviewed scientific journals

Effectiveness, cost-utility, and benefits of a multicomponent therapy to improve the quality of life of patients with fibromyalgia in primary care : a mixed methods study protocol

Introduction:Fibromyalgia (FM) is a chronic condition characterized by chronic pain, fatigue and loss of function which significantly impairs quality of life. Although treatment of FM remains disputed, some studies point at the efficacy of interdisciplinary therapy. This study aims to analyze the effectiveness, cost-utility and benefits of a multicomponent therapy on quality of life (main variable), functional impact, mood and pain in people suffering from FM that attend primary care centers (PCCs) of the Catalan Institute of Health (ICS).Methods and analysis:A 2-phase, mixed methods study has been designed following Medical Research Council guidance. Phase 1: Pragmatic randomized clinical trial with patients diagnosed with FM that attend one of the 11 PCCs of the ICS Gerència Territorial Terres de l'Ebre. We estimate a total sample of 336 patients. The control group will receive usual clinical care, while the multicomponent therapy group (MT group) will receive usual clinical care plus group therapy (consisting of health education, exercise and cognitive-behavioural therapy) during 12 weeks in 2-hourly weekly sessions. Analysis: the standardized mean response and the standardized effect size will be assessed at 3, 9, and 15 months after the beginning of the study using multiple linear regression models. Utility measurements will be used for the economic analysis. Phase 2: Qualitative socio constructivist study to evaluate the intervention according to the results obtained and the opinions and experiences of participants (patients and professionals). We will use theoretical sampling, with 2 discussion groups of participants in the multicomponent therapy and 2 discussion groups of professionals of different PCCs. A thematic content analysis will be carried out.Ethics and dissemination:This study protocol has been approved by the Clinical Research Ethics Committee of the Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (code P18/068). Articles will be published in international, peer-reviewed scientific journals.Trial registration:Clinical-Trials.gov: NCT04049006

A multiple health behaviour change intervention to prevent depression: A randomized controlled trial

Objective: To examine the effectiveness of a 12-month MHBC intervention in the prevention of onset depression in primary health care (PHC). Methods: Twenty-two PHC centres took part in the clusterrandomized controlled trial. Patients were randomized to receive either usual care or an MHBC intervention. The endpoints were onset of major depression and reduction of depressive symptoms in participants without baseline depression at a 12-month follow-up. Results: 2531 patients agreed and were eligible to participate. At baseline, around 43% were smokers, 82% were non-adherent to the Mediterranean diet and 55% did not perform enough physical activity. The intervention group exhibited a greater positive change in two or more behaviours (OR 1.75 [95%CI: 1.17 to 2.62]; p = 0.006); any behaviour (OR 1.58 [95%CI: 1.13 to 2.20]; p = 0.007); and adherence to the Mediterranean diet (OR 1.94 [95%CI: 1.29 to 2.94]; p = 0.002), while this increase was not statistically significant for smoking and physical activity. The intervention was not effective in preventing major depression (OR 1.17; [95% CI 0.53 to 2.59)]; p = 0.690) or reducing depressive symptoms (Mean difference: 0.30; [95% CI -0.77 to 1.36]; p = 0.726) during follow-up. Conclusions: As compared to usual care, the MHBC intervention provided a non-significant reduction in the incidence of major depression