The longitudinal relation between loneliness and perceived stress: A structural equation modelling analysis of 10,159 individuals.

AIMS: Prolonged loneliness and severe stress are increasingly recognised as public health concerns and considered risk factors for mental disorders, somatic illnesses and mortality. Loneliness and perceived stress also often co-occur; however, their longitudinal relation remains unclear. To the best of our knowledge, this is the first study aiming to investigate the longitudinal relation between loneliness and perceived stress independently of cross-sectional associations and time effects. METHODS: Designed as a population-based cohort study with repeated measurements, the present study included individuals aged 16-80 years at baseline who participated in the Danish National Health Survey ('How are you?') in 2013 and 2017 (N = 10,159; response rate = 50%). Structural equation modelling was used to examine associations between loneliness and perceived stress in the total sample and across age groups (i.e., 16-29, 30-64 and 65-80 years). RESULTS: The models indicated bidirectional relations between loneliness and perceived stress. The standardized cross-lagged path from loneliness to perceived stress (ß: 0.12, 95% confidence interval (CI) (0.08, 0.16), p < 0.001) and from perceived stress to loneliness (ß: 0.12, 95% CI (0.07, 0.16), p < 0.001) both corresponded to small effect sizes in the total sample. Additionally, the results indicated strong cross-sectional associations, especially among adolescents and young adults (16-29 years), and high temporal stability, especially among the elderly (65-80 years). CONCLUSIONS: Loneliness and perceived stress mutually predict each other over time. The finding of both substantial bidirectional and cross-sectional associations demonstrates an interdependence between loneliness and perceived stress that may be relevant to consider in future interventions.

Translation and Validation of a Brief Health Literacy Instrument for School-Age Children in a Danish Context.

Low health literacy (HL) is associated with adverse health behaviors and poor health, and brief, high-quality instruments for measuring HL in children are scarce. The Health Literacy for School-Aged Children (HLSAC) instrument is a 10-item theory-based and internationally validated tool for measuring HL. The purpose of this study was to translate and validate the HLSAC instrument among Danish school-aged children. The instrument was translated into Danish by a standardized forward-backward translation process, and then pre-tested for face validity with 61 pupils from four schools. Thereafter, the instrument was tested among 805 pupils in grades 6 to 7 (age 11-14 years) from 15 schools. When HL was modeled as one latent factor with all 10 items loading on this factor, the confirmative factor analysis showed standardized factor loadings from 0.52 to 0.75 (p < .001) and an excellent model fit. The association between HL and food intake as a health behavior example (p < .001, r2 = .027) indicates the predictive validity of the instrument. The internal consistency was high (Cronbach's alpha = 0.86). Thus, a valid and reliable version of the HLSAC instrument is available in Danish for future surveys to monitor HL and guide health promotion targeting children and adolescents. [HLRP: Health Literacy Research and Practice. 2022;6(1):e25-e29.].

Seeking a deeper understanding of 'distributed health literacy': A systematic review.

BACKGROUND: Previous research suggests that it would be useful to view health literacy as a set of 'distributed competencies', which can be found dispersed through the individual's social network, rather than an exclusively individual attribute. However, to date there is no focused exploration of how distributed health literacy has been defined, conceptualized or assessed in the peer-reviewed literature. AIMS: This systematic review aimed to explore: (1) definitions and conceptual models of distributed health literacy that are available from the peer-reviewed literature; and (2) how distributed health literacy has been measured in empirical research. METHODS: We searched MEDLINE, Embase, CINAHL, PsycInfo, Scopus, ERIC and Web of Science using truncated versions of the keywords 'literacy' and 'distributed' (within five words' distance). We collated the definitions and conceptual models of distributed health literacy, and report on how health literacy has been measured in empirical research studies. Findings related to distributed health literacy from included manuscripts were synthesized using thematic synthesis. RESULTS: Of the 642 studies screened, 10 were included in this systematic review. The majority were empirical manuscripts reporting on qualitative research in one of five countries, with two reviews, one conceptual analysis and one quantitative study. Edwards' definition of distributed health literacy, which emphasizes the health literacy abilities, skills and practices of others that contribute to an individual's level of health literacy was widely applied in a variety of clinical and geographical settings. However, we did not identify any quantitative instruments which directly measured distributed health literacy. There was significant variability in questions used to explore the concept qualitatively, and discrepancies across studies in regard to (a) what constitutes distributed health literacy and what does not (e.g., general social support), and (b) the relationship between distributed health literacy and other constructs (e.g., public health literacy). CONCLUSION: Although there is a widely applied definition of distributed health literacy, our review revealed that the research space would benefit from the development of the concept, both theoretically for example via conceptual distinctions between distributed health literacy and other types of social support, and empirically for example through the development of a quantitative measurement instrument. PATIENT OR PUBLIC CONTRIBUTION: This paper is a systematic review and did not involve patients or the public.

Bump2Baby and Me: protocol for a randomised trial of mHealth coaching for healthy gestational weight gain and improved postnatal outcomes in high-risk women and their children.

BACKGROUND: Gestational diabetes (GDM) impacts 8-18% of pregnancies and greatly increases both maternal and child risk of developing non-communicable diseases such as type 2 diabetes and obesity. Whilst lifestyle interventions in pregnancy and postpartum reduce this risk, a research translation gap remains around delivering implementable interventions with adequate population penetration and participation. Impact Diabetes Bump2Baby is an implementation project of an evidence-based system of care for the prevention of overweight and obesity. Bump2Baby and Me is the multicentre randomised controlled trial investigating the effectiveness of a mHealth coaching programme in pregnancy and postpartum for women at high risk of developing GDM. METHODS: Eight hundred women will be recruited in early pregnancy from 4 clinical sites within Ireland, the UK, Spain, and Australia. Women will be screened for eligibility using the validated Monash GDM screening tool. Participants will be enrolled from 12 to 24 weeks' gestation and randomised on a 1:1 basis into the intervention or control arm. Alongside usual care, the intervention involves mHealth coaching via a smartphone application, which uses a combination of synchronous and asynchronous video and text messaging, and allows for personalised support and goal setting with a trained health coach. The control arm receives usual care. All women and their children will be followed from early pregnancy until 12 months postpartum. The primary outcome will be a difference in maternal body mass index (BMI) of 0.8 kg/m2 at 12 months postpartum. Secondary maternal and infant outcomes include the development of GDM, gestational weight gain, pregnancy outcomes, improvements in diet, physical activity, sleep, and neonatal weight and infant growth patterns. The 5-year project is funded by the EU Commission Horizon 2020 and the Australian National Health and Medical Research Council. Ethical approval has been received. DISCUSSION: Previous interventions have not moved beyond tightly controlled efficacy trials into routine service delivery. This project aims to provide evidence-based, sustainable support that could be incorporated into usual care for women during pregnancy and postpartum. This study will contribute evidence to inform the early prevention of non-communicable diseases like obesity and diabetes in mothers and the next generation. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12620001240932 . Registered on 19 November 2020.

Work in Progress: A Report on Health Literacy in Denmark and the Netherlands.

This report focuses on the development of health literacy in two European countries, Denmark and the Netherlands. Denmark is part of the Nordic region, while the Netherlands is situated in the Western part of Europe. The report includes examples on Danish and Dutch health literacy research and lessons learned from practice. In Denmark, supported by health literacy research, health literacy developments have been advanced within some areas of practice. Health literacy advocacy initiatives promoted by the Danish Health Literacy Network and the Danish Society of Public Health provide promising perspectives for the future of health literacy in Denmark. In the Netherlands, the Dutch Health Literacy Alliance, researchers, and other relevant stakeholders are actively integrating health literacy in research and practice - both clinically and in communities. The vibrant Dutch health literacy community advocates for further national health literacy efforts to achieve governmental support.

Large diversity in Danish health literacy profiles: perspectives for care of long-term illness and multimorbidity.

BACKGROUND: Health literacy is an important, modifiable, social determinant of health. This study aims to explore health literacy challenges of people with long-term illness or multimorbidity and provide detailed profiles revealing health literacy strengths and weaknesses within a Danish population. METHODS: In this cross-sectional study among Danish individuals (n = 490), health literacy was assessed using the nine-scale Health Literacy Questionnaire (HLQ). Using multiple logistic regression and hierarchical cluster analysis, we estimated the association between HLQ scale scores and the likelihood of long-term illness and multimorbidity, and identified socio-demographic and health characteristics related to profiles of health literacy strengths and weaknesses. RESULTS: An increase in 'actively managing my health' and 'social support for health' decreased the odds of having a long-term illness [odds ratio, OR 0.53 (0.31-0.9); OR 0.43 (0.24-0.74)] and multimorbidity [OR 0.51 (0.26-0.98); OR 0.33 (0.17-0.62)], respectively. Conversely, an increase in 'healthcare provider support' increased the odds of having long-term illness [OR 2.97 (1.78-5.08)] and multimorbidity [OR 2.94 (1.53-5.87)], respectively. Five profiles were identified based on the cluster analysis. Each cluster was characterized by specific health characteristics, e.g. Cluster A by better health status (χ2 = 39.976 (4), P < 0.001) and well-being (χ2 = 28.832 (4), P < 0.001) and Cluster D by poor health status (χ2 = 39.976 (4), P < 0.001) and increased likelihood of long-term illness (χ2 = 18.641 (4), P < 0.001). CONCLUSIONS: The association of health literacy with long-term illness and multimorbidity in combination with the health literacy profiling based on cluster analysis provides a comprehensive needs assessment and a promising starting point for the development of health literacy responsive interventions.

Tele-rehabilitation and hospital-based cardiac rehabilitation are comparable in increasing patient activation and health literacy: A pilot study.

BACKGROUND: Cardiac tele-rehabilitation is defined as using information and communication technology to support rehabilitation services. However, it requires a high level of patient activation and health literacy; this has not yet been explored. AIMS: The purpose of this study was to evaluate patient activation and health literacy in tele-rehabilitation compared to hospital-based cardiac rehabilitation. METHODS: We conducted a pilot study in patients with ischaemic or heart valve disease. In a non-randomised design, 24 patients attended a 12-week tele-rehabilitation programme, and 53 matched controls a 12-week hospital-based cardiac rehabilitation programme. The primary outcome was patient activation, which was assessed using the Patient Activation Measure before the intervention, at the end of the intervention and at follow-up six months after the intervention. The secondary outcome was health literacy, assessed using three dimensions from the Health Literacy Questionnaire before rehabilitation and at six-month follow-up: actively manage my health (HLQ3), ability to engage with healthcare providers (HLQ6) and understanding health information (HLQ9). RESULTS: Patient activation improved similarly in tele-rehabilitation and hospital-based cardiac rehabilitation at all time points. Six months after the intervention, patients in tele-rehabilitation significantly improved on the dimension HLQ6 compared to patients in hospital-based cardiac rehabilitation. No significant between-group differences were found in HLQ3 or HLQ9. CONCLUSION: Tele-rehabilitation and hospital-based cardiac rehabilitation seemed to be equally successful in improving patient activation and health literacy. Tele-rehabilitation should be further tested in a randomised controlled trial, with a focus on whether patient levels of education and self-management at the initiation of rehabilitation are decisive factors for tele-rehabilitation participation.

Building school-based social capital through 'We Act - Together for Health' - a quasi-experimental study.

BACKGROUND: Social capital has been found to be positively associated with various health and well-being outcomes amongst children. Less is known about how social capital may be generated and specifically in relation to children in the school setting. Drawing on the social cohesion approach and the democratic health educational methodology IVAC (Investigation - Vision - Action - Change) the aim of this study was to examine the effect of the Health Promoting School intervention 'We Act - Together for Health' on children's cognitive social capital. METHOD: A quasi-experimental controlled pre- and post-intervention study design was conducted with 548 participants (mean age 11.7 years). Cognitive social capital was measured as: horizontal social capital (trust and support in pupils); vertical social capital (trust and support in teachers); and a sense of belonging in the school using questions derived from the Health Behaviour in School Children study. A series of multilevel ordinal logistic regression analyses was performed for each outcome to estimate the effect of the intervention. RESULT: The analyses showed no overall significant effect from the intervention on horizontal social capital or vertical social capital at the six-month follow-up. A negative effect was found on the sense of belonging in the school. Gender and grade appeared to be important for horizontal social capital, while grade was important for sense of belonging in the school. The results are discussed in relation to We Act's implementation process, our conceptual framework and methodological issues and can be used to direct future research in the field. CONCLUSION: The study finds that child participation in health education can affect the children's sense of belonging in the school, though without sufficient management support, this may have a negative effect. With low implementation fidelity regarding the Action and Change dimension of the intervention at both the school and class level, and with measurement issues regarding the concept of social capital, more research is needed to establish a firm conclusion on the importance of the children's active participation as a source for cognitive social capital creation in the school setting. TRIAL REGISTRATION: https://www.isrctn.com/ISRCTN85203017.

'He should feel your pain': Patient insights on patient-provider communication in Rwanda.

BACKGROUND:  Patient-provider communication is an interpersonal interaction between a patient and a health care provider. OBJECTIVE:  This study explored patients' communication preferences and perceptions on what factors influence the patient-provider communication in primary health care settings in Rwanda. METHODS:  In-depth semi-structured interviews with 15 individuals including 8 with limited literacy. A thematic inductive analysis was used. RESULTS:  Patients valued communication with providers and expressed the need for interacting with caring, empathic providers who can share all the information they want and involve them in their own care. Health literacy and power issues were factors that may influence patient-provider communication. Patients with limited literacy appeared to rely highly on health care providers for making decisions about and managing their health care. CONCLUSION:  The expressed preferences, including those of patients with limited literacy, aligned well with the patient-centred care model. There were indications of a power imbalance weighing on the provider's side. Although patients with limited literacy were reliant on providers for decision-making, they were ready to be more involved in the care, suggesting a potential for improved patient involvement even for patients with paternalistic care preferences. These patients' insights can impact policies and curricula to optimise clinical practice. Generated knowledge will contribute to the indispensable yet underdeveloped field of health communication in sub-Saharan Africa. PRACTICE IMPLICATIONS:  Findings call for more inclusion of patient perspectives in the patient-provider encounter. This could require more training of professionals and research on the topic, both in Rwanda and in other regions.

Higher health literacy is associated with better glycemic control in adults with type 1 diabetes: a cohort study among 1399 Danes.

AIM: Self-management of diabetes is influenced by a range of factors including the ability to access, understand, appraise, and use of health information in everyday life, which can collectively be called health literacy. We investigated associations between nine domains of health literacy and HbA1c level in people with type 1 diabetes. METHODS: A cross-sectional study was conducted with 1399 people with type 1 diabetes attending a Danish specialist diabetes clinic. Health literacy was assessed using the nine-domain Health Literacy Questionnaire. The association between health literacy and HbA1c was analyzed using linear regression with adjustment for age, sex, educational attainment and diabetes duration. RESULTS: Of the 1399 participants, 50% were women, mean age was 54 years, and mean HbA1c was 61 mmol/mol (7.8%). Higher health literacy scores were associated with lower HbA1c levels across eight of nine health literacy domains. This association remained significant after adjusting for educational attainment. Among the domains, 'Actively managing my health' had the strongest impact on HbA1c. This was in turn predicted by 'Appraising health information', 'Having sufficient information to manage health', and 'Social support for health'. CONCLUSIONS: Higher health literacy levels are associated with lower HbA1c regardless of educational background. This study highlights the importance of healthcare provision to respond to the health literacy levels of people with diabetes and to the possible need to provide program designed to enhance health literacy.

National study of the prevalence of gestational diabetes mellitus among Danish women from 2004 to 2012.

AIMS: The prevalence of gestational diabetes mellitus (GDM) is increasing worldwide. We studied the prevalence of GDM from 2004 to 2012 in Danish women aged 15-49 years using registries with records of the diagnosis of GDM at delivery. METHODS: We conducted a national register-based study of 12,538 women with a diagnosis of GDM during a pregnancy leading to a live birth in the period 2004-2012. The diagnosis of GDM was taken from the National Patient Registry and combined with the total number of births at the national level from Statistics Denmark. Prevalence estimates were reported as crude and age-standardized using Danish and international data for women aged 15-49 years. RESULTS: A total of 566,083 live births was registered in Denmark from 2004 to 2012. The age-standardized prevalence of GDM increased from 1.7% (1095/63,465) of the total births in 2004 to 2.9% (1721/56,894) of the total births in 2012. During the period 2004-2012, the age-stratified prevalence increased from 1.1 to 1.8% among women aged 15-24 years, from 1.5 to 2.6% among women aged 25-34 years and from 2.9 to 4.7% among women aged 35-49 years. The prevalence was higher among immigrants and their descendants than in native Danish women (4.06 and 2.09% in 2007 vs. 4.51 and 2.72% in 2012, respectively). CONCLUSIONS: The prevalence of GDM in Denmark has increased across all age groups. Although the prevalence is low on a global scale, attention should be paid to this development by preventive health services.

Health Literacy Mediates the Relationship Between Educational Attainment and Health Behavior: A Danish Population-Based Study.

Individuals with a lower education level frequently have unhealthier behaviors than individuals with a higher education level, but the pathway is not fully understood. The aim of this study was to investigate whether health literacy mediates the association between educational attainment and health behavior (smoking, physical inactivity, poor diet) and obesity. The study included respondents ages 25 years or older drawn from a large population-based survey conducted in 2013 (N = 29,473). Two scales from the Health Literacy Questionnaire were used: (a) Understanding health information well enough to know what to do and (b) Ability to actively engage with health care providers. Multiple mediation analyses were conducted using the Karlson-Holm-Breen method. The study showed that health literacy in general and the ability to understand health information in particular mediated the relationship between educational attainment and health behavior, especially in relation to being physically inactive (accounting for 20% of the variance), having a poor diet (accounting for 13% of the variance), and being obese (accounting for 16% of the variance). These findings suggest that strategies for improving health behavior and reducing health inequalities may benefit from adopting a stronger focus on health literacy within prevention, patient education, and other public health interventions.

Recruitment of general practices: Is a standardised approach helpful in the involvement of healthcare professionals in research?

INTRODUCTION: Health service research often involves the active participation of healthcare professionals. However, their ability and commitment to research varies. This can cause recruitment difficulties and thereby prolong the study period and inflate budgets. Solberg has identified seven R-factors as determinants for successfully recruiting healthcare professionals: relationships, reputation, requirements, rewards, reciprocity, resolution, and respect. METHOD: This is a process evaluation of the seven R-factors. We applied these factors to guide the design of our recruitment strategy as well as to make adjustments when recruiting general practices in a guideline implementation study. In the guideline implementation study, we studied the effect of outreach visits, quality reports, and new patient stratification tools for low back pain patients. RESULTS: During a period of 15 months, we recruited 60 practices, which was fewer than planned (100 practices). In this evaluation, five of Solberg's seven R-factors were successfully addressed and two factors were not. The need to involve (reciprocity) end users in the development of new software and the amount of time needed to conduct recruitment (resolution) were underestimated. CONCLUSION: The framework of the seven R-factors was a feasible tool in our recruitment process. However, we suggest further investigation in developing systematic approaches to support the recruitment of healthcare professionals to research.

Gaps in understanding health and engagement with healthcare providers across common long-term conditions: a population survey of health literacy in 29,473 Danish citizens.

OBJECTIVES: To (1) quantify levels of subjective health literacy in people with long-term health conditions (diabetes, cardiovascular disease, chronic obstructive pulmonary disease, musculoskeletal disorders, cancer and mental disorders) and compare these to levels in the general population and (2) examine the association between health literacy, socioeconomic characteristics and comorbidity in each long-term condition group. DESIGN: Population-based survey in the Central Denmark Region (n=29,473). MAIN OUTCOME MEASURES: Health literacy was measured using two scales from the Health Literacy Questionnaire (HLQ): (1) Ability to understand health information and (2) Ability to actively engage with healthcare providers. RESULTS: People with long-term conditions reported more difficulties than the general population in understanding health information and actively engaging with healthcare providers. Wide variation was found between disease groups, with people with cancer having fewer difficulties and people with mental health disorders having more difficulties in actively engaging with healthcare providers than other long-term condition groups. Having more than one long-term condition was associated with more difficulty in engaging with healthcare providers and understanding health information. People with low levels of education had lower health literacy than people with high levels of education. CONCLUSIONS: Compared with the general population, people with long-term conditions report more difficulties in understanding health information and engaging with healthcare providers. These two dimensions are critical to the provision of patient-centred healthcare and for optimising health outcomes. More effort should be made to respond to the health literacy needs among individuals with long-term conditions, multiple comorbidities and low education levels, to improve health outcomes and to reduce social inequality in health.

Association between self-reported and objectively measured physical fitness level in a middle-aged population in primary care.

AIM: To investigate the association between self-reported physical fitness level obtained by a single-item question and objectively measured fitness level in 30- to 49-year-old men and women. METHODS: From the Danish 'Check Your Health Preventive Program' 2013-2014 fitness level was assessed in 2316 participants using the Aastrand test. Additionally, participants rated their physical fitness as high, good, average, fair or low. The association of self-reported- with objectively measured fitness level was analyzed by linear regression. Categories of self-reported- and objectively measured fitness level were cross-tabulated and agreement was quantified by Kappa statistics. Gender differences within categories were investigated by Poisson regression. RESULTS: Data from 996 men and 1017 women were analyzed (excluded, n = 303). In both men and women a higher self-reported fitness level was associated with a higher objectively measured fitness level (Rall = 0.42). Kappa agreement was 0.25. Poisson regression revealed that women rated their fitness level significantly lower than men (p < 0.001). CONCLUSION: A single-item question is a cost-effective way of measuring physical fitness level, but the method has low association and fair agreement when compared to the Aastrand test. Men tend to overestimate physical fitness more than women, which should be accounted for if using the question in primary care settings.

Effectiveness of a training course for general practice nurses in motivation support in type 2 diabetes care: a cluster-randomised trial.

BACKGROUND: Type 2 diabetes is a common metabolic disease with the potential for prevention of complications. The prevention requires a high level of lasting actions from the patients, which may be burdensome. The aim of this trial was to evaluate the effectiveness of a training course for general practice nurses in motivation support at 18 months follow-up in the affiliated type 2 diabetes population. METHODS: Forty general practices with nurse-led diabetes consultations from the area of Aarhus, Denmark were randomised 1∶1 to either intervention or usual practice. Intervention practices were offered a 16-hour Self-determination theory-based course including communication training for general practice nurses delivered over 10 months. The affiliated diabetes populations (aged 40-74 years) were identified from registers (intervention n = 2,005; usual n = 2,029). Primary outcomes were register-based glycated haemoglobin (HbA1c) -, total cholesterol levels, and well-being measured by the Problem Areas In Diabetes scale (PAID) and the mental component summary score, SF12 (SF12, mcs). Intention-to-treat analyses were performed. Predefined subgroups analyses were performed. RESULTS: The differences between the intervention- and the control practices' mean HbA1c and total cholesterol at follow-up adjusted for baseline values and clustering were respectively: -0.02%-points (95% CI: -0.11 to 0.07; p: 0.67); 0.08 mmol/l (95% CI: 0.01 to 0.15; p: 0.02). Differences in median scores adjusted for clustering were for PAID: 1.25; p = 0.31 and SF12, mcs: 0.99; p = 0.15. Women in intervention practices differed from women in usual practices on mean HbA1c: -0.12%-points (-0.23 to -0.02; p = 0.02) and SF12, mcs: 2.6; p = 0.01. CONCLUSIONS: Offering a training course for general practice nurses in applying the Self-determination theory in current type 2 diabetes care had no effect compared with usual practice measured by HbA1c and total cholesterol levels and the well-being at 18 months of follow-up in a comprehensive register-based diabetes population. Subgroup analyses suggested a possible effect in women, which deserves further attention. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier NCT01187069).

Psychological distress, cardiovascular complications and mortality among people with screen-detected type 2 diabetes: follow-up of the ADDITION-Denmark trial.

AIMS/HYPOTHESIS: The aim of this study was to examine the association between psychological distress and the risk of cardiovascular disease (CVD) events and all-cause mortality in patients with screen-detected type 2 diabetes mellitus. In addition, we explored whether or not metabolic control and medication adherence could explain part of this association. METHODS: A follow-up study was performed including 1,533 patients aged 40-69 years with screen-detected type 2 diabetes mellitus identified in general practice during 2001-2006 in the Denmark arm of the ADDITION (Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen-Detected Diabetes in Primary Care) study. Mental health was measured at baseline with the Mental Health Inventory 5 (MHI-5). Psychological distress was defined as an MHI-5 score of ≤ 68 (18.2% of the population). CVD risk factors were measured at baseline and repeated at the follow-up examination. Information on death, hospital discharge diagnosis, and antihypertensive and lipid-lowering drug treatment was obtained from national registers. Cox proportional regression was used to estimate HRs for the association between psychological distress, CVD events and all-cause mortality. Age- and sex-adjusted risk difference analyses were performed to estimate differences in meeting treatment targets. RESULTS: Patients with psychological distress had a 1.8-fold higher mortality rate (HR 1.76, 95% CI 1.23, 2.53) and a 1.7-fold higher risk of having a CVD event (HR: 1.69, 95% CI 1.05, 2.70) compared with those with an MHI-5 score of >68. Overall, psychological distress was not associated with the ability to meet treatment targets for HbA1c levels, cholesterol levels or BP, or to redeem antihypertensive or lipid-lowering drug treatment. CONCLUSIONS/INTERPRETATION: In people detected and treated early in the diabetes disease trajectory, those with psychological distress at the time of diagnosis had a higher risk of CVD events and death than those without psychological distress.

A cluster randomised pragmatic trial applying Self-determination theory to type 2 diabetes care in general practice.

BACKGROUND: Treatment recommendations for prevention of type 2 diabetes complications often require radical and life-long health behaviour changes. Observational studies based on Self-determination theory (SDT) propose substantial factors for the maintenance of behaviour changes and concomitant well-being, but experimental research is needed to develop and evaluate SDT-based interventions. The aims of this paper were to describe 1) the design of a trial assessing the effectiveness of a training course for practice-nurses in autonomy support on patient-perceived motivation, HbA1, cholesterol, and well-being among a diabetes population, 2) the actual intervention to a level of detail that allows its replication, and 3) the connection between SDT recommendations for health care-provider behaviour and the content of the training course. METHODS/DESIGN: The study is a cluster-randomised pragmatic trial including 40 Danish general practices with nurse-led diabetes consultations, and the associated diabetes population. The diabetes population was identified by registers (n = 4034).The intervention was a 16-hour course with interactive training for practice nurses. The course was delivered over 4 afternoons at Aarhus University and one 1/2 hour visit to the practice by one of the course-teachers over a period of 10 months (0, 2, 5, 10 mths.). The intervention is depicted by a PaT Plot showing the timeline and the characteristics of the intervention components.Effectiveness of the intervention will be assessed on the diabetes populations with regard to well-being (PAID, SF-12), HbA1c- and cholesterol-levels, perceived autonomy support (HCCQ), type of motivation (TSRQ), and perceived competence for diabetes care (PCD) 15-21 months after the core course; the completion of the second course afternoon. Data will be retrieved from registers and by questionnaires. DISCUSSION: Challenges and advantages of the pragmatic design are discussed. In a real-world setting, this study will determine the impact on motivation, HbA1c, cholesterol, and well-being for people with diabetes by offering a training course in autonomy support to practice-nurses from general practices with nurse-led consultations. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01187069.