Study protocol for a multicenter randomized controlled trial of personalized exercise therapy and self-management support for people with multimorbidity: The MOBILIZE study.

Background: Despite the great individual and societal burden associated with multimorbidity, little is known about how to effectively manage it. Objective: The aim of this multicenter randomized controlled trial (RCT) is to investigate the 12-month effects of a personalized exercise therapy and self-management support program in addition to usual care in people with multimorbidity. Design: This is a protocol for a pragmatic, parallel-group (1:1 ratio), superiority RCT conducted at five intervention sites (two hospitals, a private practice physiotherapy clinic and two municipal rehabilitation centers) in Region Zealand, Denmark. A total of 228 persons with multimorbidity aged 18 years or older, will be randomly allocated to one of two groups. Both groups will receive usual care, defined as routine care for multimorbidity at the discretion of the treating doctor, while the intervention group will also participate in a 12-week exercise therapy and self-management support program tailored to people with multimorbidity at one of the intervention sites. The primary outcome will be the between-group difference in change in EQ-5D-5L from baseline to the follow-up at 12 months. Secondary outcomes include objectively-measured physical function and physical activity, inflammatory markers, disease and treatment burden, anxiety, depression, stress, sleep, pain and other self-reported parameters. In parallel with the RCT, an observational cohort will follow persons aged ≥18 years with multimorbidity not adhering to all eligibility criteria, as well as people fulfilling all eligibility criteria, but unwilling to participate in the RCT. This study was approved by the Regional Committee on Health Research Ethics for Region Zealand (SJ-857) and results will be communicated in scientific papers, at relevant conferences and to a broader audience. Discussion: Exercise therapy and self-management support is safe and effective in people with single conditions. However, it is still unclear whether this holds true for individuals with multimorbidity. This pragmatic, multicenter RCT will provide high-quality evidence on the benefits and harms of exercise therapy and self-management support and, if the results support it, lead to the development of a plan for implementation in clinical practice.

Predictors of undiagnosed prevalent type 2 diabetes - The Danish General Suburban Population Study.

AIMS: To investigate how self-reported risk factors (including socioeconomic status) predict undiagnosed, prevalent type 2 diabetes mellitus (T2DM). To externally validate Leicester Risk Assessment Score (LRAS), Finnish Diabetes Risk Score (FINDRISC) and Danish Diabetes Risk Score (DDRS), and to investigate how these predict a European Heart SCORE≥5% in a Danish population study. METHODS: We included 21,205 adults from the Danish General Suburban Population Study. We used relative importance calculations of self-reported variables in prediction of undiagnosed T2DM. We externally validated established prediction models reporting ROC-curves for undiagnosed T2DM, pre-diabetes and SCORE. RESULTS: More than 20% of people with T2DM were undiagnosed. The 7 most important self-rated predictors in sequential order were high BMI, antihypertensive-therapy, age, cardiovascular disease, waist-circumference, fitness compared to peers and family disposition for T2DM. The Area Under the Curve for prediction of undiagnosed T2DM was 77.1 for LRAS; 75.4 for DDRS and 67.9 for FINDRISC. AUCs for SCORE was 75.1 for LRAS; 62.3 for DDRS and 54.3 for FINDRISC. CONCLUSIONS: BMI and self-reported cardiovascular disease are important risk factors for undiagnosed T2DM. LRAS performed better than DDRS and FINDRISC in prediction of undiagnosed T2DM and SCORE≥5%. SCORE performed best in predicting pre-diabetes.

Socio-demographic determinants and effect of structured personal diabetes care: a 19-year follow-up of the randomized controlled study diabetes Care in General Practice (DCGP).

BACKGROUND: We investigated how four aspects of socio-demography influence the effectiveness of an intervention with structured personal diabetes care on long-term outcomes. METHODS: The Diabetes Care in General Practice (DCGP) study is a cluster-randomized trial involving a population-based sample of 1381 patients with newly diagnosed type 2-diabetes mellitus. We investigated how education, employment, cohabitation status and residence influenced the effectiveness of 6 years of intervention with structured personal diabetes care, resembling present day recommendations. Outcomes were incidence of any diabetes-related endpoint and death during 19 years after diagnosis, and cardiovascular risk factors, behaviour, attitudes and process-of-care variables 6 years after diagnosis. RESULTS: Structured personal care reduced the risk of any diabetes-related endpoint and the effect of the intervention was modified by geographical area (interaction p = 0.034) with HR of 0.71 (95%CI: 0.60-0.85) and of 1.07 (95%CI: 0.77-1.48), for patients in urban and rural areas, respectively. Otherwise, there was no effect modification of education, employment and civil status on the intervention for the final endpoints. There were no noticeable socio-demographic differences in the effect of the intervention on cardiovascular risk factors, behaviour, attitudes, and process-of-care. CONCLUSION: Structured personal care reduced the aggregate outcome of any diabetes-related endpoint and independent of socio-demographic factors similar effect on cardiovascular risk factors, behaviour, attitudes and process of care, but the intervention did not change the existing inequity in mortality and morbidity. Residence modified the uptake of the intervention with patients living in urban areas having more to gain of the intervention than rural patients, further investigations is warranted. TRIAL REGISTRATION: ClinicalTrials.gov registration no. NCT01074762 (February 24, 2010).

Social disparities in diabetes care: a general population study in Denmark.

OBJECTIVE: We investigated the association between socioeconomic factors and the attainment of treatment goals and pharmacotherapy in patients with type 2 diabetes in Denmark. DESIGN: A cross-sectional population study. SETTING: The municipality of Naestved, Denmark. SUBJECTS: We studied 907 patients with type 2 diabetes identified from a random sample of 21,205 Danish citizens. MAIN OUTCOME MEASURES: The proportion of patients who were not achieving goals for diabetes care based on their HbA1c, LDL-cholesterol, blood pressure, and lifestyle, and the proportion of patients who were treated with antihypertensive and cholesterol- and glucose-lowering medication. METHODS: We investigated the association of the socioeconomic factors such as age, gender, education, occupation, income, and civil status and attainment of treatment goals and pharmacotherapy in logistic regression analyses. We investigated effect modification of cardiovascular disease and kidney disease. RESULTS: Middle age (40-65 years), low education level (i.e. basic schooling), and low household income (i.e. less than 21,400 € per year) were associated with nonattainment of goals for diabetes care. The association of socioeconomic factors with attainment of individual treatment goals varied. Patients with low socioeconomic status were more often obese, physically inactive, smoking, and had elevated blood pressure. Socioeconomic factors were not associated with treatment goals for hyperglycemia. Socioeconomic factors were inconsistently associated with pharmacotherapy. There was no difference in contacts to general practitioners according to SES. CONCLUSIONS: In a country with free access to health care, the socioeconomic factors such as middle age, low education, and low income were associated with nonattainment of goals for diabetes care. KEY POINTS Middle age, low education, and low income were associated with nonattainment of goals for diabetes care, especially for lifestyle goals. Patients with low socioeconomic status were more often obese, physically inactive, smoking, and had elevated blood pressure. Association of socioeconomic factors with pharmacotherapy was inconsistent.

LIFESTAT - Living with statins: An interdisciplinary project on the use of statins as a cholesterol-lowering treatment and for cardiovascular risk reduction.

AIM: LIFESTAT is an interdisciplinary project that leverages approaches and knowledge from medicine, the humanities and the social sciences to analyze the impact of statin use on health, lifestyle and well-being in cohorts of Danish citizens. The impetus for the study is the fact that 10% of the population in the Scandinavian countries are treated with statins in order to maintain good health and to avoid cardiovascular disease by counteracting high blood levels of cholesterol. The potential benefit of treatment with statins should be considered in light of evidence that statin use has prevalent and unintended side effects (e.g. myalgia, and glucose and exercise intolerance). METHODS: The LIFESTAT project combines invasive human experiments, biomedical analyses, nationwide surveys, epidemiological studies, qualitative interviews, media content analyses, and ethnographic participant observations. The study investigates the biological consequences of statin treatment; determines the mechanism(s) by which statin use causes muscle and mitochondrial dysfunction; and analyzes achievement of treatment goals, people's perception of disease risk, media influence on people's risk and health perception, and the way people manage to live with the risk (personally, socially and technologically). CONCLUSIONS THE ORIGINALITY AND SUCCESS OF LIFESTAT DEPEND ON AND DERIVE FROM ITS INTERDISCIPLINARY APPROACH, IN WHICH THE DISCIPLINES CONVERGE INTO THOROUGH AND HOLISTIC STUDY AND DESCRIBE THE IMPACT OF STATIN USE ON THE EVERYDAY LIFE OF STATIN USERS THIS HAS THE POTENTIAL FOR MUCH GREATER BENEFIT THAN ANY ONE OF THE DISCIPLINES ALONE INTEGRATING TRADITIONAL DISCIPLINES PROVIDES NOVEL PERSPECTIVES ON POTENTIAL CURRENT AND FUTURE SOCIAL, MEDICAL AND PERSONAL BENEFITS OF STATIN USE.

Childhood asthma after bacterial colonization of the airway in neonates.

BACKGROUND: Pathological features of the airway in young children with severe recurrent wheeze suggest an association between bacterial colonization and the initiating events of early asthma. We conducted a study to investigate a possible association between bacterial colonization of the hypopharynx in asymptomatic neonates and later development of recurrent wheeze, asthma, and allergy during the first 5 years of life. METHODS: The subjects were children from the Copenhagen Prospective Study on Asthma in Childhood birth cohort who were born to mothers with asthma. Aspirates from the hypopharyngeal region of asymptomatic 1-month-old infants were cultured for Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Staphylococcus aureus. Wheeze was monitored prospectively on diary cards during the first 5 years of life. Blood eosinophil count and total IgE and specific IgE were measured at 4 years of age. Lung function was measured and asthma was diagnosed at 5 years of age. RESULTS: Hypopharyngeal samples were cultured from 321 neonates at 1 month of age. Twenty-one percent of the infants were colonized with S. pneumoniae, M. catarrhalis, H. influenzae, or a combination of these organisms; colonization with one or more of these organisms, but not colonization with S. aureus, was significantly associated with persistent wheeze (hazard ratio, 2.40; 95% confidence interval [CI], 1.45 to 3.99), acute severe exacerbation of wheeze (hazard ratio, 2.99; 95% CI, 1.66 to 5.39), and hospitalization for wheeze (hazard ratio, 3.85; 95% CI, 1.90 to 7.79). Blood eosinophil counts and total IgE at 4 years of age were significantly increased in children colonized neonatally with S. pneumoniae, M. catarrhalis, H. influenzae, or a combination of these organisms, but specific IgE was not significantly affected. The prevalence of asthma and the reversibility of airway resistance after beta2-agonist administration at 5 years of age were significantly increased in the children colonized neonatally with these organisms as compared with the children without such colonization (33% vs. 10% and 23% vs. 18%, respectively). CONCLUSIONS: Neonates colonized in the hypopharyngeal region with S. pneumoniae, H. influenzae, or M. catarrhalis, or with a combination of these organisms, are at increased risk for recurrent wheeze and asthma early in life.