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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.

ABSTRACT: 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.

SUBMITTER: Zabaleta-Del-Olmo E

PROVIDER: S-EPMC6045838 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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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.

Zabaleta-Del-Olmo Edurne E Pombo Haizea H Pons-Vigués Mariona M Casajuana-Closas Marc M Pujol-Ribera Enriqueta E López-Jiménez Tomás T Cabezas-Peña Carmen C Martín-Borràs Carme C Serrano-Blanco Antoni A Rubio-Valera Maria M Llobera Joan J Leiva Alfonso A Vicens Caterina C Vidal Clara C Campiñez Manuel M Martín-Álvarez Remedios R Maderuelo José-Ángel JÁ Recio José-Ignacio JI García-Ortiz Luis L Motrico Emma E Bellón Juan-Ángel JÁ Moreno-Peral Patricia P Martín-Cantera Carlos C Martín-Cantera Carlos C Clavería Ana A Aldecoa-Landesa Susana S Magallón-Botaya Rosa R Bolíbar Bonaventura B

BMC public health 20180713 1

<h4>Background</h4>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 mu ...[more]

PMID: 30005705

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Project description:BackgroundMultiple 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.MethodsAn 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.ResultsThe 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.ConclusionThe efficiency of EIRA intervention cannot be fully established and its recommendation should be conditioned by results on medium-long term effects.Trial registrationClinicaltrials.gov NCT03136211 . Registered 02 May 2017 - Retrospectively registered.

Project description:BackgroundThis 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.MethodsA 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.Results14.5% 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.ConclusionsCompared 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 registrationClinicalTrials.gov , NCT03136211 . Registered 2 May 2017, "retrospectively registered".

Project description:ObjectiveThis study examined the prevalence of impaired fasting glucose (IFG) and diabetes and their associated factors in 17,184 Chinese hypertensive adults aged 45-75 years.MethodsA cross-sectional investigation was carried out in a rural area of Lianyungang, China. Previously undiagnosed diabetes [fasting plasma glucose (FPG) ≥ 7.0 mmol/l] and IFG (6.1-6.9 mmol/l) were defined based on FPG concentration. Previously diagnosed diabetes was determined on the basis of self-report. Total diabetes included both previously diagnosed diabetes and previously undiagnosed diabetes.ResultsThe prevalence of previously diagnosed diabetes, undiagnosed diabetes, and IFG were 3.4%, 9.8%, and 14.1%, respectively. About 74.2% of the participants with diabetes had not previously been diagnosed. In the multivariable logistic-regression model, older age, men, antihypertensive treatment, obesity (BMI ≥ 25 kg/m(2)), abdominal obesity (waist circumference ≥ 90 cm for men and ≥ 80 cm for women), non-current smoking, a family history of diabetes, higher heart rate, lower physical activity levels, and inland residence (versus coastal) were significantly associated with both total diabetes and previously undiagnosed diabetes. Furthermore, methylene- tetrahydrofolate reductase (MTHFR) 677 TT genotype was an independent associated factor for total diabetes, and current alcohol drinking was an independent associated factor for previously undiagnosed diabetes. At the same time, older age, men, abdominal obesity, non-current smoking, current alcohol drinking, a family history of diabetes, higher heart rate, and inland residence (versus coastal) were important independent associated factors for IFG.ConclusionIn conclusion, we found a high prevalence of diabetes in Chinese hypertensive adults. Furthermore, about three out of every four diabetic adults were undiagnosed. Our results suggest that population-level measures aimed at the prevention, identification (even if only based on the FPG evaluation), and treatment of diabetes should be urgently taken to overcome the diabetes epidemic in Chinese hypertensive adults.

Project description:BackgroundA small proportion of the older population accounts for a high proportion of healthcare use. For effective use of limited healthcare resources, it is important to identify the group with greatest needs. The aim of this study was to explore frequency and reason for hospitalisation and cumulative mortality, in an older population at predicted high risk of hospital admission, and to assess if a prediction model can be used to identify individuals with the greatest healthcare needs. Furthermore, discharge diagnoses were explored to investigate if they can be used as basis for specific interventions in the high-risk group.MethodsAll residents, 75 years or older, living in Östergötland, Sweden, on January 1st, 2017, were included. Healthcare data from 2016 was gathered and used by a validated prediction model to create risk scores for hospital admission. The population was then divided into groups by percentiles of risk. Using healthcare data from 2017-2018, two-year cumulative incidence of hospitalisation was analysed using Gray´s test. Cumulative mortality was analysed with the Kaplan-Meier method and primary discharge diagnoses were analysed with standardised residuals.ResultsForty thousand six hundred eighteen individuals were identified (mean age 82 years, 57.8% women). The cumulative incidence of hospitalisation increased with increasing risk of hospital admission (24% for percentiles < 60 to 66% for percentiles 95-100). The cumulative mortality also increased with increasing risk (7% for percentiles < 60 to 43% for percentiles 95-100). The most frequent primary discharge diagnoses for the population were heart diseases, respiratory infections, and hip injuries. The incidence was significantly higher for heart diseases and respiratory infections and significantly lower for hip injuries, for the population with the highest risk of hospital admission (percentiles 85-100).ConclusionsIndividuals 75 years or older, with high risk of hospital admission, were demonstrated to have considerable higher cumulative mortality as well as incidence of hospitalisation. The results support the use of the prediction model to direct resources towards individuals with highest risk scores, and thus, likely the greatest care needs. There were only small differences in discharge diagnoses between the risk groups, indicating that interventions to reduce hospitalisations should be personalised.Trial registrationclinicaltrials.gov Identifier: NCT03180606, first posted 08/06/2017.

Project description:BackgroundOlder patients with type 2 diabetes mellitus represent a heterogeneous group in terms of metabolic profile. It makes glucose-lowering-therapy (GLT) complex to manage, as it needs to be individualised according to the patient profile. This study aimed to identify and characterize subgroups existing among older patients with diabetes.MethodsRetrospective observational cohort study of outpatients followed in a Belgian diabetes clinic. Included participants were all aged ?75?years, diagnosed with type 2 diabetes, Caucasian, and had a Homeostasis Model Assessment (HOMA2). A latent profile analysis was conducted to classify patients using the age at diabetes diagnosis and HOMA2 variables, i.e. insulin sensitivity (HOMA2%-S), beta-cell-function (HOMA2%-?), and the product between both (HOMA2%-?xS; as a measure of residual beta-cell function). GLT was expressed in defined daily dose (DDD).ResultsIn total, 147 patients were included (median age: 80?years; 37.4% women; median age at diabetes diagnostic: 62?years). The resulting model classified patients into 6 distinct cardiometabolic profiles. Patients in profiles 1 and 2 had an older age at diabetes diagnosis (median: 68?years) and a lesser decrease in HOMA2%-S, as compared to other profiles. They also presented with the highest HOMA2%-?xS values. Patients in profiles 3, 4 and 5 had a moderate decrease in HOMA2%-?xS. Patients in profile 6 had the largest decrease in HOMA2%-? and HOMA2%-?xS. This classification was associated with significant differences in terms of HbA1c values and GLT total DDD between profiles. Thus, patients in profiles 1 and 2 presented with the lowest HbA1c values (median: 6.5%) though they received the lightest GLT (median GLT DDD: 0.75). Patients in profiles 3 to 5 presented with intermediate values of HbA1c (median: 7.3% and GLT DDD (median: 1.31). Finally, patients in profile 6 had the highest HbA1c values (median: 8.4%) despite receiving the highest GLT DDD (median: 2.28). Other metabolic differences were found between profiles.ConclusionsThis study identified 6 groups among patients ?75?years with type 2 diabetes by latent profile analysis, based on age at diabetes diagnosis, insulin sensitivity, absolute and residual ?-cell function. Intensity and choice of GLT should be adapted on this basis in addition to other existing recommendations for treatment individualisation.

Project description:Little is known regarding the health and lifestyle behaviours of Australians of Lebanese ethnicity. The available evidence suggests that Australians of Lebanese ethnicity who were born in Lebanon reportedly have higher rates of cardiovascular disease-related and type 2 diabetes-related complications when compared with the wider Australian population. The aim of this study is to compare lifestyle behaviours of middle-aged to older adults of Lebanese ethnicity born in Lebanon, Australia, and elsewhere to those of Australian ethnicity. Participants were 37,419 Australians aged ?45 years, from the baseline dataset of The 45 and Up Study which included 4 groups of interest: those of Australian ethnicity (n = 36,707) [Reference]; those of Lebanese ethnicity born in Lebanon (n = 346); 302 those of Lebanese ethnicity born in Australia (n = 302); and those of Lebanese ethnicity born elsewhere (n = 64). Multilevel logistic regression was used to examine the odds of those of Lebanese ethnicity reporting suboptimal lifestyle behaviours (insufficient physical activity, prolonged sitting, smoking, sleep duration, and various diet-related behaviours) relative to those of Australian ethnicity. Multilevel linear regression was used to examine the clustering of suboptimal lifestyle behaviours through a 'lifestyle index' score ranging from 0-9 (sum of all lifestyle behaviours for each subject). The lifestyle index score was lower among Lebanese-born (-0.36, 95% CI -0.51, -0.22, p<0.001) and Australian-born (-0.17, 95% CI -0.32, -0.02, p = 0.031) people of Lebanese ethnicity in comparison to those of Australian ethnicity. Those of Lebanese ethnicity born in Lebanon had higher odds of reporting suboptimal lifestyle behaviours for physical activity, smoking, and sleep duration, and lower odds of reporting optimal lifestyle behaviours for sitting time, fruit, processed meat, and alcohol consumption, when compared with those of Australian ethnicity. Differences in the individual lifestyle behaviours for those of Lebanese ethnicity born in Australia and elsewhere compared with those of Australian ethnicity were fewer. Lifestyle behaviours of those of Lebanese ethnicity vary by country of birth and a lower level of suboptimal lifestyle behaviour clustering was apparent among Lebanese-born and Australian-born middle-aged to older adults of Lebanese ethnicity.

Project description:IntroductionThe current study sought to explore the effect of baseline serum uric acid (SUA) on the risk of all-cause mortality among Chinese adults aged 45~75 years and to determine its interaction relationship with diabetes.MethodsThe study was designed as a community-based cohort of 4467 adults aged between 45~75 years included in a 6-years follow-up period from 2009 to 2015 years by the China Health and Nutrition Survey (CHNS). Baseline SUA levels were grouped into quartiles and its association on all-cause mortality was explored using multivariate Cox proportional hazards models. Stratified analyses were performed to explore the associations of SUA quartiles with all-cause mortality among diabetic and non-diabetic individuals.ResultsA total of 141 deaths (5.3 per 1000 person-years) were recorded During a follow-up of 26431 person-years. Out of the 141 deaths, 28 deaths (10.1 per 1000 person-years) were reported in the diabetic groups and 113 deaths (4.8 per 1000 person-years) were recorded in the non-diabetic group. An increased risk of all-cause mortality was observed for participants in the first and fourth quartiles compared with the second SUA quartile, (Q1 SUA: aHR=2.1, 95% CI 1.1~4.1; Q4 SUA: aHR=2.1, 95% CI 1.1~4.0). Stratification of participants by diabetes status showed a U-shaped association for non-diabetic individuals. Whereas, declined eGFR, rather than SUA, was an independent risk factor for all-cause mortality in diabetic individuals (aHR=0.7, 95% CI 0.6~1.0).ConclusionOur study proved that the prognostic role of SUA for predicting all-cause death might be regulated by diabetes. Both low and high SUA levels were associated with increased mortality, supporting a U-shaped association only in non-diabetic individuals. Whereas, renal dysfunction rather than SUA was an independent risk factor for all-cause mortality. Further studies should be conducted to determine the SUA levels at which intervention should be conducted and explore target follow-up strategies to prevent progression leading to poor prognosis.

Project description:IntroductionModifiable lifestyle factors are considered key to the control of cardiometabolic diseases. This study aimed to explore the association between multiple lifestyle factors and cardiometabolic multimorbidity.MethodsA total of 14,968 participants were included in this cross-sectional exploratory study (mean age 54.33 years, range 45-91; 49.6% male). Pearson's Chi-square test, logistic regression, and latent class analysis were employed.ResultsWe found that men with 4-5 high-risk lifestyle factors had a 2.54-fold higher risk (95% CI: 1.60-4.04) of developing multimorbidity compared to males with zero high-risk lifestyle factors. In an analysis of dietary behavior, we found that in women compared to men, over-eating (OR = 1.94, P < 0.001) and intra-meal water drinking (OR = 2.15, P < 0.001) were more likely to contribute to the development of cardiometabolic multimorbidity. In an analysis of taste preferences, men may be more sensitive to the effect of taste preferences and cardiometabolic multimorbidity risk, particularly for smoky (OR = 1.71, P < 0.001), hot (OR = 1.62, P < 0.001), and spicy (OR = 1.38, P < 0.001) tastes. Furthermore, "smoking and physical activity" and "physical activity and alcohol consumption" were men's most common high-risk lifestyle patterns. "Physical activity and dietary intake" were women's most common high-risk lifestyle patterns. A total of four common high-risk dietary behavior patterns were found in both males and females.ConclusionsThis research reveals that the likelihood of cardiometabolic multimorbidity increases as high-risk lifestyle factors accumulate. Taste preferences and unhealthy dietary behaviors were found to be associated with an increased risk of developing cardiometabolic multimorbidity and this association differed between genders. Several common lifestyle and dietary behavior patterns suggest that patients with cardiometabolic multimorbidity may achieve better health outcomes if those with certain high-risk lifestyle patterns are identified and managed.

Dataset Information

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.

Publications

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.

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