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 cluster-randomized 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. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03136211.

Utility of PHQ-2, PHQ-8 and PHQ-9 for detecting major depression in primary health care: a validation study in Spain.

BACKGROUND: Primary health care (PHC) professionals may play a crucial role in improving early diagnosis of depressive disorders. However, only 50% of cases are detected in PHC. The most widely used screening instrument for major depression is the Patient Health Questionnaire (PHQ), including the two-, eight- and nine-item versions. Surprisingly, there is neither enough evidence about the validity of PHQ in PHC patients in Spain nor indications about how to interpret the total scores. This study aimed to gather validity evidence to support the use of the three PHQ versions to screen for major depression in PHC in Spain. Additionally, the present study provided information for helping professionals to choose the best PHQ version according to the context. METHODS: The sample was composed of 2579 participants from 22 Spanish PHC centers participating in the EIRA-3 study. The reliability and validity of the three PHQ versions for Spanish PHC patients were assessed based on responses to the questionnaire. RESULTS: The PHQ-8 and PHQ-9 showed high internal consistency. The results obtained confirm the theoretically expected relationship between PHQ results and anxiety, social support and health-related QoL. A single-factor solution was confirmed. Regarding to the level of agreement with the CIDI interview (used as the criterion), our results indicate that the PHQ has a good discrimination power. The optimal cut-off values were: ⩾2 for PHQ-2, ⩾7 for PHQ-8 and ⩾8 for PHQ-9. CONCLUSIONS: PHQ is a good and valuable tool for detecting major depression in PHC patients in Spain.

Use a web-app to improve breast cancer risk factors and symptoms knowledge and adherence to healthy diet and physical activity in women without breast cancer diagnosis (Precam project).

PURPOSE: This study aimed to evaluate the preliminary effectiveness of an educational intervention using a web-app to improve knowledge of breast cancer risk factors and symptoms and adherence to healthy eating and physical activity among women without breast cancer diagnosis in Asturias (Spain). METHODS: A pragmatic randomized pilot trial was conducted to evaluate the impact of a web-app-based intervention for women without breast cancer diagnosis. Women in the intervention group participated in a 6-month intervention web-app based on the Behaviour Change Wheel Model. The web-app includes information about breast cancer risk factors, early detection, physical activity and diet. RESULTS: Two hundred and eighty-fifth women aged 25-50 were invited to join the study. Two hundred and twenty-four were randomly assigned to either the intervention group (IG = 134) or control group (CG = 90) according to their place of residence. Adherence among women in the IG increased significantly from pre- to post-intervention for eight of the 12 healthy behaviors and for the identification of six risk factors and six symptoms compared to women in the CG and, among whom adherence only increased for two behaviors, the identification of one risk factor and 0 symptoms. The intervention significantly improved the mean number of risk factors + 1.06 (p < 0.001) and symptoms + 1.18 (p < 0.001) identified by women in the IG. CONCLUSIONS: The preliminary results of this study suggest that an educational intervention using a web-app and based on the Behaviour Change Wheel model could be useful to improve knowledge of breast cancer risk factors and symptoms and to improve adherence to a healthy diet and physical activity in women without a previous breast cancer diagnosis.

Dynamics of multimorbidity and frailty, and their contribution to mortality, nursing home and home care need: A primary care cohort of 1 456 052 ageing people.

Background: Prevalence of both multimorbidity and frailty increases with age, but more evidence is needed to elucidate their relationship and their association with other health-related outcomes. We analysed the dynamics of both conditions as people age and calculate the associated risk of death, nursing home admission, and need for home care. Methods: Data were drawn from the primary care electronic health records of a longitudinal cohort of people aged 65 or older in Catalonia in 2010-2019. Frailty and multimorbidity were measured using validated instruments (eFRAGICAP, a cumulative deficit model; and SNAC-K, respectively), and their longitudinal evolution was described. Cox regression models accounted for the competing risk of death and adjusted by sex, socioeconomical status, and time-varying age, alcohol and smoking. Findings: We included 1 456 052 patients. Prevalence of multimorbidity was consistently high regardless of age, while frailty almost quadrupled from 65 to 99 years. Frailty worsened and also changed with age: up to 84 years, it was more related to concurrent diseases, and afterwards, to frailty-related deficits. While concurrent diseases contributed more to mortality, frailty-related deficits increased the risk of institutionalisation and the need for home care. Interpretation: The nature of people's multimorbidity and frailty vary with age, as does their impact on health status. People become frailer as they age, and their frailty is more characterised by disability and other symptoms than by diseases. Mortality is most associated with the number of comorbidities, whereas frailty-related deficits are associated with needing specialised care. Funding: Instituto de Salud Carlos III through PI19/00535, and the PFIS Grant FI20/00040 (Co-funded by European Regional Development Fund/European Social Fund).

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.

BACKGROUND: 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. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03136211 . Registered 2 May 2017, "retrospectively registered".

Implementation of the EIRA 3 Intervention by Targeting Primary Health Care Practitioners: Effectiveness in Increasing Physical Activity.

The World Health Organization (WHO) estimated that physical inactivity (PI) is responsible for 20 to 30% of all non-communicable diseases. We aimed to analyze the effectiveness of a multiple health behavior change (MHBC) intervention to increase physical activity (PA) in patients 45 to 75 years old who had at least 2 of 3 unhealthy behaviors (tobacco use, reduced fruit and vegetable consumption, and insufficient PA). The MHBC intervention is based on the Transtheoretical Model and the conceptual framework of the "5 A's" and includes an individually tailored intervention, group sessions, and the use of community resources. We included 3062 participants, 1481 in the intervention group and 1581 in the control group. After 12 months, there were no differences in PA intensity measured by metabolic_equivalent_of_task_minutes/week (adjusted mean difference: 284.093, 95% CI: -298.24, 866.42) nor in the proportion of participants who increased PA levels to moderate or high (OR: 1.02, 95% CI: 0.85, 1.23; p = 0.822), and no differences in blood pressure, weight loss, or waist circumference. We found an increased proportion of patients in the intervention group who followed the WHO recommendations for PA (OR: 1.29; 95% CI: 1.04, 1.60; p = 0.02). We concluded that the intervention did not lead to a significant increase in PA.

Cost-effectiveness analysis of a multiple health behaviour change intervention in people aged between 45 and 75 years: a cluster randomized controlled trial in primary care (EIRA study).

BACKGROUND: Multiple health behaviour change (MHBC) interventions that promote healthy lifestyles may be an efficient approach in the prevention or treatment of chronic diseases in primary care. This study aims to evaluate the cost-utility and cost-effectiveness of the health promotion EIRA intervention in terms of MHBC and cardiovascular reduction. METHODS: An economic evaluation alongside a 12-month cluster-randomised (1:1) controlled trial conducted between 2017 and 2018 in 25 primary healthcare centres from seven Spanish regions. The study took societal and healthcare provider perspectives. Patients included were between 45 and 75 years old and had any two of these three behaviours: smoking, insufficient physical activity or low adherence to Mediterranean dietary pattern. Intervention duration was 12 months and combined three action levels (individual, group and community). MHBC, defined as a change in at least two health risk behaviours, and cardiovascular risk (expressed in % points) were the outcomes used to calculate incremental cost-effectiveness ratios (ICER). Quality-adjusted life-years (QALYs) were estimated and used to calculate incremental cost-utility ratios (ICUR). Missing data was imputed and bootstrapping with 1000 replications was used to handle uncertainty in the modelling results. RESULTS: The study included 3062 participants. Intervention costs were €295 higher than usual care costs. Five per-cent additional patients in the intervention group did a MHBC compared to usual care patients. Differences in QALYS or cardiovascular risk between-group were close to 0 (- 0.01 and 0.04 respectively). The ICER was €5598 per extra health behaviour change in one patient and €6926 per one-point reduction in cardiovascular risk from a societal perspective. The cost-utility analysis showed that the intervention increased costs and has no effect, in terms of QALYs, compared to usual care from a societal perspective. Cost-utility planes showed high uncertainty surrounding the ICUR. Sensitivity analysis showed results in line with the main analysis. CONCLUSION: The efficiency of EIRA intervention cannot be fully established and its recommendation should be conditioned by results on medium-long term effects. TRIAL REGISTRATION: Clinicaltrials.gov NCT03136211 . Registered 02 May 2017 - Retrospectively registered.

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

OBJECTIVE: 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. RESULTS: 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.

Complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in primary 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 ideal setting for health promotion but multifaceted barriers make its integration difficult in the usual care. The majority of the adult population engages two or more risk behaviours, that is why a multiple intervention might be more effective and efficient. The primary objectives are to evaluate the effectiveness, the cost-effectiveness and an implementation strategy of a complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in PHC. METHODS: This study is a cluster randomised controlled hybrid type 2 trial with two parallel groups comparing a complex multiple risk behaviour intervention with usual care. It will be carried out in 26 PHC centres in Spain. The study focuses on people between 45 and 75 years who carry out two or more of the following unhealthy behaviours: 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 the routine care of PHC practices according to the conceptual framework of the "5A's". It will have a maximum duration of 12 months and it will be carried out to three different levels (individual, group and community). Incremental cost per quality-adjusted life year gained measured by the tariffs of the EuroQol-5D questionnaire will be estimated. The implementation strategy is based on the "Consolidated Framework for Implementation Research", a set of discrete implementation strategies and an evaluation framework. DISCUSSION: EIRA study will determine the effectiveness and cost-effectiveness of a complex multiple risk intervention and will provide a better understanding of implementation processes of health promotion interventions in PHC setting. It may contribute to increase knowledge about the individual and structural barriers that affect implementation of these interventions and to quantify the contextual factors that moderate the effectiveness of implementation. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03136211 .Retrospectively registered on May 2, 2017.

Factors related to the development of health-promoting community activities in Spanish primary healthcare: two case-control studies.

OBJECTIVE: Spanish primary healthcare teams have the responsibility of performing health-promoting community activities (CAs), although such activities are not widespread. Our aim was to identify the factors related to participation in those activities. DESIGN: Two case-control studies. SETTING: Performed in primary care of five Spanish regions. SUBJECTS: In the first study, cases were teams that performed health-promoting CAs and controls were those that did not. In the second study (on case teams from the first study), cases were professionals who developed these activities and controls were those who did not. MAIN OUTCOME MEASURES: Team, professional and community characteristics collected through questionnaires (team managers/professionals) and from secondary sources. RESULTS: The first study examined 203 teams (103 cases, 100 controls). Adjusted factors associated with performing CAs were percentage of nurses (OR 1.07, 95% CI 1.01 to 1.14), community socioeconomic status (higher vs lower OR 2.16, 95% CI 1.18 to 3.95) and performing undergraduate training (OR 0.44, 95% CI 0.21 to 0.93). In the second study, 597 professionals responded (254 cases, 343 controls). Adjusted factors were professional classification (physicians do fewer activities than nurses and social workers do more), training in CAs (OR 1.9, 95% CI 1.2 to 3.1), team support (OR 2.9, 95% CI 1.5 to 5.7), seniority (OR 1.06, 95% CI 1.03 to 1.09), nursing tutor (OR 2.0, 95% CI 1.1 to 3.5), motivation (OR 3.7, 95% CI 1.8 to 7.5), collaboration with non-governmental organisations (OR 1.9, 95% CI 1.2 to 3.1) and participation in neighbourhood activities (OR 3.1, 95% CI 1.9 to 5.1). CONCLUSIONS: Professional personal characteristics, such as social sensitivity, profession, to feel team support or motivation, have influence in performing health-promoting CAs. In contrast to the opinion expressed by many professionals, workload is not related to performance of health-promoting CAs.

Evidence from interventions based on theoretical models for lifestyle modification (physical activity, diet, alcohol and tobacco use) in primary care settings: A systematic review.

OBJECTIVE: To determine the effectiveness of health promotion interventions based on theoretical models of behavioral change to modify the main lifestyle factors (physical activity, diet, alcohol and tobacco) in adults receiving primary health care (PHC). METHODS: We searched the MEDLINE and Cochrane Database of Systematic Reviews from January 2000 to December 2012. Two reviewers independently performed the first screening of titles and abstracts, the methodological quality assessment using the lecturacritica.com tool, and the extraction of necessary data to systematize the available information. RESULTS: Only few studies met the inclusion criteria (17 studies from 30 articles). Thirteen were randomized controlled trials, three systematic reviews, and one observational study. The transtheoretical model was the most frequent (13 studies), and obtained strong evidence of its effectiveness for dietary interventions in the short-term and for smoking cessation interventions in the long-term as compared to usual PHC practice. Limited evidence was found for smoking cessation interventions based in the social cognitive theory. CONCLUSION: There are few studies that explicitly link intervention strategies and theories of behavioral change. A rigorous evaluation of the theoretical principles could help researchers and practitioners to understand how and why interventions succeed or fail.

[Cigarette smoking prevalence and associated factors in secondary school children in Catalunya]. / Prevalencia y factores asociados al consumo de tabaco en alumnos de enseñanza secundaria de Cataluña.

OBJECTIVE: The aim of this study was to analyze those factors associated with cigarette smoking in adolescent school children, in order to plan future school interventions for promoting good health strategies developed by the schools and Primary Health Care professionals. DESIGN: Cross-sectional study with a two-stage cluster sampling. SETTING: The study included 97 schools, and was carried out in 2005-06 in Catalonia (Spain). PARTICIPANTS: 14-16 year-old secondary school children. MAIN MEASURES: The survey was based on a self-administered paper-based questionnaire that collected sociodemographic variables, academic level, health status, family variables, sexual relations, addictive substances, mood state, and variables related to opinions on cigarette smoking The association between these variables and smoker/non-smoker variable was analyzed, as well as factors that could increase the probability of becoming a smoker using multilevel models. RESULTS: A total of 9340 completed questionnaires, including 4653 from males, were received from the pupils, with a mean age of 15.2 years. The results showed that 71.1% of pupils were non-smokers, 75% of whom were males and 67.3% of females. The following factors increased the probability of becoming a smoker (OR and 95%CI): being a female 0.60 (0.53-0.68), being in the 4(th) year 1.27 (1.12-1.43), low academic performance 3.38 (2.74-4.17), self-reported regular/poor health status 2.81 (2.21-3.58), smoking parents 1.68 (1.45-1.95), alcohol consumption 5.05 (4.35-5.86), having 3 or more problems of mood state 1.22 (1.05-1.41), living without parents 1.59 (1.07-2.38), agreeing with tobacco industry advertising 1.64 (1.45-1.85) and believing that tobacco acts as a relaxant 3.57 (3.23-4.17). CONCLUSIONS: Although the majority of pupils were non-smokers, smoking was more prevalent among females. The factors associated with cigarette smoking in the adolescents included sociodemographic, sociocultural, and personal environmental factors, as well as their opinions on the habit.

[Resources and models for diabetic foot care in Catalonia (Spain): a descriptive study on areas of improvement]. / Recursos y modelos de atención al pie diabético en Cataluña (España): estudio descriptivo sobre espacios de mejora.

OBJECTIVES: To identify areas of improvement in diabetic foot care as regards the availability of materials and specialties in primary and secondary care. To determine the model of care for surgical centres and hospitals caring for diabetic foot problems and their relation to amputations. DESIGN: Cross-sectional study SETTING AND PARTICIPANTS: Random sample of 36 basic health areas (BHA) and all hospital surgery centres in Catalonia (Spain). MEASUREMENTS: Information was collected by structured interview of managers of each centre on: availability of specialists, material off-loading and examination. The models were established according to the classification of Van Acker, and amputations from hospital discharge records. RESULTS: An endocrinologist was available in 36.1% [confidence interval (CI) 95%:19.0-53.2] of the BHA and 11.1% [95% CI: 3.1-26.1] had a podiatrist,100% [95% CI: 90.3-100.0] had Doppler, 91.7% [95% CI:77.5-98.2] a monofilament, 5.6% [95% CI: 0.7-18.7] a quantitative tuning fork, 11.1% [95% CI:3,1-26, 1] material off-loading, and 8.3% [95% CI: 1.8 - 22.5] a specialist reference centre. A total of 85 surgical centres and hospitals dealt with these problems: 11(13.0%) excellent model, 29 (34.1%) intermediate and 45 (52.9%) basic/insufficient. Centres with a basic model/insufficient performed 12.5% of the amputation, intermediate models, 56.4%, and 31.1% in excellent models. CONCLUSIONS: The proportion of ABS with materials, specialists and/or specialist reference centres was low. The basic/insufficient model was the most common among surgical/hospital centres. Most amputations were performed in centres with excellent and intermediate model; nevertheless, a considerable percentage was performed in centres with basic/insufficient models.