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Background Health coaching is a patient-centred approach to supporting self-management for the chronic conditions. However, long-term evidence of effectiveness of health coaching remains scarce. The object of this study was to evaluate the long-term effect of telephone health coaching (THC) on mortality and morbidity among people with type 2 diabetes (T2D), coronary artery disease (CAD) and congestive heart failure (CHF).. Methods 1535 T2D, CAD and CHF patients with unmet treatment targets were randomly allocated into an intervention group ( n  = 1034) and control group ( n  = 501). Intervention group received monthly individual strength-based, autonomy supportive THC sessions (average 30 min) for behavior change with a specially trained nurse for 12 months additional to usual health care. Control group received usual health care services. The primary outcome was a composite of death from cardiovascular causes or non-fatal stroke or non-fatal myocardial infarction (AMI) or unstable angina pectoris (UAP) during a follow-up of 8 years Three other composite endpoints with distinct combinations of fatal and non-fatal cardiovascular events and death from any cause were used as secondary outcomes. Other outcomes followed were the most relevant components of the composite endpoints. Randomized controlled trial (RCT) data was linked to Finnish national health and social care registries and electronic health records (EHR). Post-trial eight-year evaluation was conducted using intention-to-treat (ITT) and per-protocol (PP) analysis. Results The composite primary outcome event rate per 100 person years was lower in the intervention group (3.45) than in control group (3.88) in ITT -analysis, but the difference was not statistically significant (hazard ratio in the intervention group 0.87; 95% CI, 0.71 to 1.07; P  = 0.19). In the subgroup (T2D, CAD/CHF) analysis, there were no statistically significant effects. The secondary PP-analysis showed statistically significant benefits for those who participated in the study. Conclusions No statistically significant effect of health coaching on mortality and morbidity was found in intention to treat analysis. The per protocol results suggest, however, that the intervention may be effective among patients who are willing and able to participate in health coaching. More research is needed to identify patients most likely to benefit from low-intensity health coaching. Trial registration NCT00552903 (registration date: the 1st of November 2007, updated the 3rd of February 2009).

Background The aim was to evaluate the effect of a 12-month individualized health coaching intervention by telephony on clinical outcomes. Methods An open-label cluster-randomized parallel groups trial. Pre- and post-intervention anthropometric and blood pressure measurements by trained nurses, laboratory measures from electronic medical records (EMR). A total of 2594 patients filling inclusion criteria (age 45 years or older, with type 2 diabetes, coronary artery disease or congestive heart failure, and unmet treatment goals) were identified from EMRs, and 1535 patients (59%) gave consent and were randomized into intervention or control arm. Final analysis included 1221 (80%) participants with data on primary end-points both at entry and at end. Primary outcomes were systolic and diastolic blood pressure, serum total and LDL cholesterol concentration, waist circumference for all patients, glycated hemoglobin (HbA 1c ) for diabetics and NYHA class in patients with congestive heart failure. The target effect was defined as a 10-percentage point increase in the proportion of patients reaching the treatment goal in the intervention arm. Results The proportion of patients with diastolic blood pressure initially above the target level decreasing to 85 mmHg or lower was 48% in the intervention arm and 37% in the control arm (difference 10.8%, 95% confidence interval 1.5–19.7%). No significant differences emerged between the arms in the other primary end-points. However, the target levels of systolic blood pressure and waist circumference were reached non-significantly more frequently in the intervention arm. Conclusions Individualized health coaching by telephony, as implemented in the trial was unable to achieve majority of the disease management clinical measures. To provide substantial benefits, interventions may need to be more intensive, target specific sub-groups, and/or to be fully integrated into local health care. Trial registration ClinicalTrials.gov Identifier: NCT00552903

Background The burden of chronic disease and multimorbidity is rapidly increasing. Self-management support interventions are effective in reduce cost, especially when targeted at a single disease group; however, economical evidence of such complex interventions remains scarce. The objective of this study was to evaluate a cost-effectiveness analysis of a tele-based health-coaching intervention among patients with type 2 diabetes (T2D), coronary artery disease (CAD) and congestive heart failure (CHF). Methods A total of 1570 patients were blindly randomized to intervention ( n  = 970) and control ( n  = 470) groups. The intervention group received monthly individual health coaching by telephone from a specially trained nurse for 12-months in addition to routine social and healthcare. Patients in the control group received routine social and health care. Quality of life was assessed at the beginning of the intervention and follow-up measurements were made after 12 months health coaching. The cost included all direct health-care costs supplemented with home care and nursing home-care costs in social care. Utility was based on a Health Related Quality of Life (HRQoL) measurement (15D instrument), and cost effectiveness was assessed using incremental cost-effectiveness ratios (ICERs). Results The cost-effectiveness of health coaching was highest in the T2D group (ICER €20,000 per Quality-Adjusted Life Years [QALY]). The ICER for the CAD group was more modest (€40,278 per QALY), and in the CHF group, costs increased with no marked effect on QoL. Probabilistic sensitivity analysis indicated that at the societal willingness to pay threshold of €50,000 per QALY, the probability of health coaching being cost effective was 55% in the whole study group. Conclusions The cost effectiveness of health coaching may vary substantially across patient groups, and thus interventions should be targeted at selected subgroups of chronically ill. Based on the results of this study, health coaching improved the QoL of T2D and CAD patients with moderate costs. However, the results are grounded on a short follow-up period, and more evidence is needed to evaluate the long-term outcomes of health-coaching programs. Trial registration NCT00552903 [Prospectively registered, registration date 1 st November 2007, last updated 3 rd February 2009].

Type 2 Diabetes Prevention in the Real World Three-year results of the GOAL Lifestyle Implementation Trial Pilvikki Absetz , PHD 1 , Brian Oldenburg , PHD 2 , Nelli Hankonen , MSOCSCI 1 , Raisa Valve , PHD 3 , Heikki Heinonen , PHD 1 , Aulikki Nissinen , MD, PHD 1 , Mikael Fogelholm , SCD 4 , Martti Talja , MD, PHD 5 and Antti Uutela , PHD 1 1 National Institute for Health and Welfare, Helsinki, Finland; 2 Monash University, Melbourne, Australia; 3 University of Helsinki, Lahti, Finland; 4 Academy of Finland, Helsinki, Finland; 5 Päijät-Häme Central Hospital, Lahti, Finland. Corresponding author: Pilvikki Absetz, pilvikki.absetz{at}thl.fi . Abstract OBJECTIVE We study the effectiveness of the GOAL Lifestyle Implementation Trial at the 36-month follow-up. RESEARCH DESIGN AND METHODS Participants ( n = 352, type 2 diabetes risk score FINDRISC = 16.2 ± 3.3, BMI 32.6 ± 5.0 kg/m 2 ) received six lifestyle counseling sessions over 8 months. Measurements were at baseline, 12 months (88.6%), and 36 months (77.0%). RESULTS Statistically significant risk reduction at 12 months was maintained at 36 months in weight (−1.0 ± 5.6 kg), BMI (−0.5 ± 2.1 kg/m 2 ), and serum total cholesterol (−0.4 ± 1.1 mmol/l). CONCLUSIONS Maintenance of risk reduction in this “real world” trial proves the intervention's potential for significant public health impact. Footnotes The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact. Received January 9, 2009. Accepted April 23, 2009. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/licenses/by-nc-nd/3.0/ for details. © 2009 by the American Diabetes Association.

\"Real-world\" implementation of lifestyle interventions is a challenge. The Good Ageing in Lahti Region (GOAL) Lifestyle Implementation Trial was designed for the primary health care setting, with lifestyle and risk reduction objectives derived from the major diabetes prevention efficacy trials. We report on the program's effectiveness as well as findings related to the program's reach, adoption, and implementation. A total of 352 middle-aged participants with elevated type 2 diabetes risk were recruited from the health care centers in Päijät-Häme Province in Finland. The intervention included six group counseling sessions, delivered by trained public health nurses. Measurement was conducted at baseline and 12 months. Clinical risk factors were measured by study nurses, and lifestyle outcomes were analyzed from self-reports. Lifestyle outcomes were compared with the outcomes achieved in relevant efficacy trials, and within-subject changes were tested for risk reduction. At baseline, mean BMI was >32 kg/m2, and 25% of the participants had impaired glucose tolerance. At 12 months, 20% of participants achieved at least four of five key lifestyle outcomes, with these results being comparable with the reference trials. However, physical activity and weight loss goals were achieved significantly less frequently (65 vs. 86% and 12 vs. 43%, respectively). Several clinical risk factors decreased, more so among men than women. This trial demonstrates that lifestyle counseling can be effective and is feasible in real-world settings for individuals with elevated risk of type 2 diabetes. To increase program impact, program exposure and treatment intensity need to be increased.

OBJECTIVE: We study the effectiveness of the GOAL Lifestyle Implementation Trial at the 36-month follow-up. RESEARCH DESIGN AND METHODS: Participants (n = 352, type 2 diabetes risk score FINDRISC = 16.2 ± 3.3, BMI 32.6 ± 5.0 kg/m²) received six lifestyle counseling sessions over 8 months. Measurements were at baseline, 12 months (88.6%), and 36 months (77.0%). RESULTS: Statistically significant risk reduction at 12 months was maintained at 36 months in weight (-1.0 ± 5.6 kg), BMI (-0.5 ± 2.1 kg/m²), and serum total cholesterol (-0.4 ± 1.1 mmol/l). CONCLUSIONS: Maintenance of risk reduction in this \"real world\" trial proves the intervention's potential for significant public health impact.

Type 2 Diabetes Prevention in the “Real World” One-year results of the GOAL Implementation Trial Pilvikki Absetz , PHD 1 , Raisa Valve , PHD 2 , Brian Oldenburg , PHD 3 , Heikki Heinonen , PHD 1 , Aulikki Nissinen , MD, PHD 1 , Mikael Fogelholm , SCD 4 , Vesa Ilvesmäki , MD, PHD 5 , Martti Talja , MD, PHD 5 and Antti Uutela , PHD 1 1 Department of Health Promotion and Chronic Disease Prevention, National Public Health Institute, Helsinki, Finland 2 Palmenia Centre for Continuing Education, University of Helsinki, Lahti, Finland 3 Department of Epidemiology, Monash University, Melbourne, Australia 4 UKK Institute for Health Promotion, Tampere, Finland 5 Päijät-Häme Central Hospital, Lahti, Finland Address correspondence and reprint requests to Pilvikki Absetz, Senior Researcher, Health Promotion and Chronic Disease Prevention, National Public Health Institute, Mannerheimintie 166, FI-00300 Helsinki, Finland. E-mail: pilvikki.absetz{at}ktl.fi Abstract OBJECTIVE —“Real-world” implementation of lifestyle interventions is a challenge. The Good Ageing in Lahti Region (GOAL) Lifestyle Implementation Trial was designed for the primary health care setting, with lifestyle and risk reduction objectives derived from the major diabetes prevention efficacy trials. We report on the program's effectiveness as well as findings related to the program's reach, adoption, and implementation. RESEARCH DESIGN AND METHODS —A total of 352 middle-aged participants with elevated type 2 diabetes risk were recruited from the health care centers in Päijät-Häme Province in Finland. The intervention included six group counseling sessions, delivered by trained public health nurses. Measurement was conducted at baseline and 12 months. Clinical risk factors were measured by study nurses, and lifestyle outcomes were analyzed from self-reports. Lifestyle outcomes were compared with the outcomes achieved in relevant efficacy trials, and within-subject changes were tested for risk reduction. RESULTS —At baseline, mean BMI was >32 kg/m 2 , and 25% of the participants had impaired glucose tolerance. At 12 months, 20% of participants achieved at least four of five key lifestyle outcomes, with these results being comparable with the reference trials. However, physical activity and weight loss goals were achieved significantly less frequently (65 vs. 86% and 12 vs. 43%, respectively). Several clinical risk factors decreased, more so among men than women. CONCLUSIONS —This trial demonstrates that lifestyle counseling can be effective and is feasible in real-world settings for individuals with elevated risk of type 2 diabetes. To increase program impact, program exposure and treatment intensity need to be increased. DPS, Finnish Diabetes Prevention Study GOAL, Good Ageing in Lahti Region Footnotes Published ahead of print at http://care.diabetesjournals.org on 22 June 2007. DOI: 10.2337/dc07-0171. Clinical trial reg. no NCT00398060, clinicaltrials.gov. A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances. The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C Section 1734 solely to indicate this fact. Accepted June 19, 2007. Received January 29, 2007. DIABETES CARE

Study objective: To (1) describe the setting and design of the Good Ageing in Lahti Region (GOAL) programme; (2) by using the baseline results of the GOAL cohort study, to examine whether living in urban, semi-urban, or rural communities is related to risk factors for chronic diseases and functional disability in ageing individuals. Design: The baseline data of a cohort study of ageing individuals living in three community types (urban, semi-urban, rural). Data were collected by two questionnaires and laboratory assessments. Setting: Fourteen municipalities in the Lahti region (Päijät-Häme County) in Finland. Participants: A regionally and locally stratified random sample of men and women born in 1946-50, 1936-40, and 1926-30. A total of 4,272 were invited and 2,815 (66%) participated. Main results: Elevated serum cholesterol, obesity, disability, sedentary lifestyle (<2 times/week walking), and high fat intake were more prevalent in rural vs. urban and semiurban communities. After adjustment for sex, age, education, obesity, diet, physical activity, smoking, and alcohol use, rural communities remained the only community type with increased (p<0.05) probability for high BMI (OR 1.33) and high waist circumference (OR 1.43). Conclusions: The unfavourable health and lifestyle profile, together with an old population, makes health promotion for elderly citizens a special challenge for rural communities such as those in Päijät-Häme County, Finland. Most, if not all, of the differences in health between the three community types were explained by educational background, physical activity, and smoking.

Drug-eluting stents are a recent innovation for endovascular and endourethral purposes. The aim of this study was to assess the biocompatibility of new biodegradable drug-eluting stent materials in vivo. Rods made of SR-PLDLA (self-reinforced poly-96L,4D: -lactic acid) covered with P(50L/50D)LA and rods made of 96L/4D SR-PLA and covered with P(50L/50D)LA including indomethacin 3.3 microg/mm(2)or dexamethasone 1.5 microg/mm(2), were inserted into the dorsal muscles of 20 rabbits serving as test animals. Rods made of silicone and organotin-positive polyvinylchloride were used as negative and positive controls. The animals were sacrificed after 1 week, 1 month, 2 months or 4 months. Histological changes attributable to the operative trauma were seen in all specimens at 1 week and 1 month. At 2 months both dexamethasone and indomethacin induced less fibrosis than the plain SR-PLDLA covered with P(50L/50D)LA without drug. At 4 months dexamethasone induced both chronic inflammatory changes and foreign body reaction, whereas the reactions in the indomethacin and drug-free plain SR-PLDLA groups were insignificant. The new biodegradable drug-eluting stent materials are highly biocompatible. Drug-eluting biodegradable stents may offer a promising new treatment modality for vascular and urethral diseases. However, further studies are needed to demonstrate their feasibility and efficacy.

The purpose of this study was to evaluate the biocompatibility, encrustation and biodegradation properties of silver nitrate and ofloxacine blended caprolactone-L-lactide copolymer coated self-reinforced poly-L-lactic acid (SR-PLLA) urospirals in situ in the male rabbit urethra. SR-PLLA urospirals coated with 10% by weight silver nitrate or 5% by weight ofloxacine blended copolymer or pure copolymer were inserted into the posterior urethra of 18 male rabbits. No prophylactic antibiotics were given. The animals were sacrificed 1 or 6 months after insertion. Urethral tissue reactions were histologically scored semiquantitavely and the appearence of the stents assessed using scanning electron microscopy. The biodegradation time of SR-PLLA stents was remarkably reduced by the caprolactone coating. Silver nitrate and ofloxacine blended copolymer coated urospirals caused less tissue reaction than urospirals with a pure copolymer coating. Silver nitrate coating effectively prevented biofilm formation and stent encrustation. Silver nitrate and ofloxacine blended copolymer coated SR-PLLA urospirals had good biocompatibility properties in rabbit urethra. In particular, coating with silver nitrate may provide possibilities of preventing bacterial adhesion to bioabsorbable stents.