Effectiveness of a Lifestyle Modification Program Delivered under Real-World Conditions in a Rural Setting.
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SUBMITTER: Jennings C
PROVIDER: S-EPMC8620632 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Background: Idarucizumab has been included in guidelines for the management of bleeding or surgical procedure in dabigatran-treated patients without need for biological monitoring. The aim of the study was to assess the prognostic value of dabigatran plasma level before reversal to test the hemostatic efficacy of idarucizumab. The secondary objectives were (i) to analyze plasma dabigatran level according to the risk of rebound and (ii) to evaluate the incidence of post-reversal non-favorable clinical outcomes (including thromboembolism, bleeding, antithrombotic, and death) and antithrombotic resumption. Methods and Results: This was an observational multicentric cohort study, which included all French patients who required idarucizumab for dabigatran reversal. Between May 2016 and April 2019, 87 patients from 21 French centers were enrolled. Patients received idarucizumab for overt bleeding (n = 61), urgent procedures (n = 24), or overdose without bleeding (n = 2). Among patients with major bleeding (n = 57), treatment with idarucizumab was considered effective in 44 (77.2%) of them. Patients who did not achieve effective hemostasis after reversal had a significantly higher mean level of plasma dabigatran at baseline (524.5 ± 386 vs. 252.8 ng/mL ± 235, p = 0.033). Furthermore, patients who did not achieve effective hemostasis after reversal had less favorable outcomes during follow-up (46.2 vs. 81.8%, p = 0.027). ROC curve identified a cutoff of 264 ng/mL for dabigatran level at admission to be predictive of ineffective hemostasis. No plasma dabigatran rebound was observed after reversal in patients with dabigatran plasma level < 264 ng/mL at baseline. Conclusion: This retrospective study shows that dabigatran level before reversal could predict hemostatic effectiveness and dabigatran plasma rebound after idarucizumab injection.
| S-EPMC7772865 | biostudies-literature
Project description:BackgroundThis real-world study examined clinical characteristics and dyslipidemia management among patients initiating evolocumab across 12 European countries. Austrian data are reported.MethodsData of consenting adults were collected for ≤ 6 months prior to evolocumab initiation (baseline) and ≤ 30 months post-initiation. Patient characteristics, lipid lowering therapy (LLT, i.e. statin and/or ezetimibe) and lipid values were collected from medical records.ResultsIn Austria, 363 patients were enrolled. At baseline, 52% of patients initiated evolocumab without background LLT; the median (Q1, Q3) initial low-density lipoprotein cholesterol (LDL-C) level was 142 (111, 187) mg/dL. Within 3 months of evolocumab treatment, median LDL‑C decreased by 59% to 58 (37, 91) mg/dL. This reduction was maintained over time, despite consistently infrequent use of background LLT. LDL-C < 55 mg/dL was attained by 65% of patients (76% with, 55% without background LLT). Evolocumab persistence was ≥ 90% at month 12 and month 30.ConclusionIn Austria, patients were initiated on evolocumab at LDL‑C levels almost 3‑times higher than the guideline-recommended clinical goal (< 55 mg/dL). Persistence with evolocumab was very high. Evolocumab led to a rapid and sustained LDL‑C reduction with 65% attaining the LDL‑C goal. Patients using evolocumab in combination with statins and/or ezetimibe were more likely to attain their LDL‑C goal and thus decrease cardiovascular risk.
| S-EPMC10837260 | biostudies-literature
Project description:Rising levels of obesity in South Africa require innovation in community-level lifestyle change programmes. Our aim was to co-develop Impilo neZenkolo ('Health through Faith'), a healthy lifestyle programme for low-income, black South Africans delivered through churches, and evaluate its feasibility, acceptability and potential effectiveness. In the first phase we developed programme materials with church members. In the second phase we trained lay leaders to deliver the programme and assessed feasibility, acceptability (observation, focus groups and interviews) and potential effectiveness (pre and post measurement of weight, hip and waist circumferences, blood pressure, self-reported physical activity, dietary habits, health status, self-esteem, psychological distress). The study was conducted in four churches in urban and rural South Africa. The development workshops led to increased focus on positive benefits of participation, widening inclusion criteria to all adults and greater emphasis on Christian ethos. Challenges to feasibility included: recruitment of churches; scheduling of programme sessions (leading to one church not delivering the programme); attendance at the programme (63% attended more than half of the 12 weekly sessions); and poor programme fidelity (in particular in teaching behaviour change techniques). Aspects of the programme were acceptable, particularly the way in which the programme was aligned with a Christian ethos. There was some indication that amongst the 42/68 (62%) for whom we were obtained pre- and post-programme measurements the programme has potential to support weight loss. We conclude that a healthy lifestyle programme for low-income, black South Africans, delivered through churches, may be viable with extensive re-development of delivery strategies. These include finding external funding for the programme, endorsement from national level denominational organisations and the professionalization of programme leadership, including paid rather than volunteer leaders to ensure sufficient time can be spent in training.
| S-EPMC6668772 | biostudies-literature
Project description:OBJECTIVE To explore the potential long-term health and economic consequences of lifestyle interventions for diabetic patients. RESEARCH DESIGN AND METHODS A literature search was performed to identify interventions for diabetic patients in which lifestyle issues were addressed. We selected recent (2003-2008), randomized controlled trials with a minimum follow-up of 12 months. The long-term outcomes for these interventions, if implemented in the Dutch diabetic population, were simulated with a computer-based model. Costs and effects were discounted at, respectively, 4 and 1.5% annually. A lifelong time horizon was applied. Probabilistic sensitivity analyses were performed, taking account of variability in intervention costs and (long-term) treatment effects. RESULTS Seven trials with 147-5,145 participants met our predefined criteria. All interventions improved cardiovascular risk factors at > or =1 year follow-up and were projected to reduce cardiovascular morbidity over lifetime. The interventions resulted in an average gain of 0.01-0.14 quality-adjusted life-years (QALYs) per participant. Health benefits were generally achieved at reasonable costs (< or =euro50,000/QALY). A self-management education program (X-PERT) and physical activity counseling achieved the best results with > or =0.10 QALYs gained and > or =99% probability to be very cost-effective (< or =euro20,000/QALY). CONCLUSIONS Implementation of lifestyle interventions would probably yield important health benefits at reasonable costs. However, essential evidence for long-term maintenance of health benefits was limited. Future research should be focused on long-term effectiveness and multiple treatment strategies should be compared to determine incremental costs and benefits of one over the other.
| S-EPMC2713648 | biostudies-literature
Project description:PurposeCoronavirus disease 2019 (COVID-19) has highlighted the need for new methods of pharmacovigilance. Here, we use adult community volunteers to obtain systematic information on vaccine effectiveness and the nature and severity of breakthrough infections.MethodsBetween December 15, 2020 and September 16, 2021, 11,826 unpaid community-based volunteers reported the following information to an on-line registry: COVID-19 test results, vaccination (Pfizer, Moderna, or Johnson & Johnson) and COVID-19 symptoms. COVID-19 infections were described based on vaccination status at the time of infection: 1) fully vaccinated, 2) partially vaccinated (received first of two-dose vaccines or were <14 days post-final dose), or 3) unvaccinated.ResultsAmong 8554 participants who received any COVID-19 vaccine, COVID-19 infections were reported by 74 (1.0%) of those who were fully vaccinated and 198 (2.3%) of those who were partially vaccinated at the time of infection. Among the 74 participants who reported a breakthrough infection after full vaccination, the median time from vaccination to reported positive test result was 104.5 days (interquartile range: 77-135 days), with no difference among vaccine manufacturers. One quarter (25.7%) of breakthrough infections in the fully vaccinated cases were asymptomatic and most (>97%) fully vaccinated participants reported no symptoms or only mild symptoms compared to 89.3% of the unvaccinated cases. Only 1.4% of fully vaccinated participants reported experiencing at least 3 moderate-to-severe symptoms compared to 7.8% in the unvaccinated.ConclusionPerson-generated health data, also referred to as patient-reported outcomes, is a useful approach for quantifying breakthrough infections and their severity and for comparing vaccines.Trial registrationClinicaltrials.gov NCT04368065, EU PAS Register EUPAS36240.
| S-EPMC9451035 | biostudies-literature
Project description:Background:The public health crisis of obesity leads to increasing morbidity that are even more profound in certain populations such as rural adults. Live, two-way video-conferencing is a modality that can potentially surmount geographic barriers and staffing shortages. Methods:Patients from the Dartmouth-Hitchcock Weight and Wellness Center were recruited into a pragmatic, single-arm, nonrandomized study of a remotely delivered 16-week evidence-based healthy lifestyle programme. Patients were provided hardware and appropriate software allowing for remote participation in all sessions, outside of the clinic setting. Our primary outcomes were feasibility and acceptability of the telemedicine intervention, as well as potential effectiveness on anthropometric and functional measures. Results:Of 62 participants approached, we enrolled 37, of which 27 completed at least 75% of the 16-week programme sessions (27% attrition). Mean age was 46.9 ± 11.6 years (88.9% female), with a mean body mass index of 41.3 ± 7.1 kg/m2 and mean waist circumference of 120.7 ± 16.8 cm. Mean patient participant satisfaction regarding the telemedicine approach was favourable (4.48 ± 0.58 on 1-5 Likert scale-low to high) and 67.6/75 on standardized questionnaire. Mean weight loss at 16 weeks was 2.22 ± 3.18 kg representing a 2.1% change (P < .001), with a loss in waist circumference of 3.4% (P = .001). Fat mass and visceral fat were significantly lower at 16 weeks (2.9% and 12.5%; both P < .05), with marginal improvement in appendicular skeletal muscle mass (1.7%). In the 30-second sit-to-stand test, a mean improvement of 2.46 stands (P = .005) was observed. Conclusion:A telemedicine-delivered, intensive weight loss intervention is feasible, acceptable, and potentially effective in rural adults seeking weight loss.
| S-EPMC6934425 | biostudies-literature
Project description:PurposeFew evidence-based strategies are specifically tailored for disparity populations such as rural adults. Two-way video-conferencing using telemedicine can potentially surmount geographic barriers that impede participation in high-intensity treatment programs offering frequent visits to clinic facilities. We aimed to understand barriers and facilitators of implementing a telemedicine-delivered tertiary-care, rural academic weight-loss program for the management of obesity.MethodsA single-arm study of a 16-week, weight-loss pilot evaluated barriers and facilitators to program participation and exploratory measures of program adoption and staff confidence in implementation and intervention delivery. A program was delivered using video-conferencing within an existing clinical infrastructure. Elements of Consolidated Framework for Implementation Research (CFIR) provided a basis for assessing intervention characteristics, inner and outer settings, and individual characteristics using surveys and semi-structured interviews. We evaluated elements of the RE-AIM model (reach, adoption) to assess staff barriers to success for future scalability.FindingsThere were 27 patients and 8 staff completing measures. Using CFIR, the intervention was valuable from a patient participant standpoint; staff equally had positive feelings about using telemedicine as useful for patient care. The RE-AIM framework demonstrated limited reach but willingness to adopt was above average. A significant barrier limiting sustainability was physical space for intervention delivery and privacy and dedicated resources for staff. Scheduling stressors were also a challenge in its implementation.ConclusionsThe need to engage staff, enhance organizational culture, and increase reach are major factors for rural health obesity clinics to enhance sustainability of using telemedicine for the management of obesity.Trial registrationClinicaltrials.gov NCT03309787. Registered on 16 October 2017.
| S-EPMC7526351 | biostudies-literature
Project description:BackgroundThe Lifestyle Interventions and Independence for Elders (LIFE) clinical trial demonstrated that a structured program of physical activity (PA) reduced mobility-disability in older adults by up to 28%. It remains unknown whether the benefits of LIFE PA can be translated to older adults at risk for mobility-disability in real-world community-based settings. To address this knowledge gap, we conducted the ENhancing independence using Group-based community interventions for healthy AGing in Elders (ENGAGE) pilot study and examined the safety, feasibility, and preliminary effectiveness of translating LIFE PA to a community-based senior center.MethodsForty older adults with severe lower extremity functional limitations (age: 76.9 ± 7.3 years; body mass index: 32.7 ± 8 kg/m2; 85% female; short physical performance battery score: 6.3 ± 2.2) were randomized to 24 weeks of PA or a health education control intervention.ResultsCommunity-based PA was safe (serious adverse events: PA vs health education, 0:2; nonserious adverse events: PA vs health education, 3:1) and participants successfully adhered to the PA intervention (65.2%). Compared to health education, PA participants who attended ≥25% of scheduled visits had meaningful and sustained short physical performance battery improvements at follow-up (between group short physical performance battery score differences: ~0.7 units).ConclusionsENGAGE has demonstrated the preliminary safety, feasibility, and effectiveness of LIFE PA in a real-world community-based setting. Larger-scale translational studies are needed to further disseminate the benefits of LIFE PA to vulnerable older adults in a variety of community-based settings.
| S-EPMC6521918 | biostudies-literature
Project description:BackgroundGroup-based lifestyle change programs based on the Diabetes Prevention Program (DPP) are associated with clinically significant weight loss and decreases in cardiometabolic risk factors. However, these benefits depend on successful real-world implementation. Studies have examined implementation in community settings, but less is known about integration in healthcare systems, and particularly in large, multi-site systems with the potential for extended reach.ObjectiveTo examine the barriers and facilitators to successful DPP implementation in a large multi-site healthcare system.DesignSemi-structured interviews, based on the RE-AIM framework, were conducted in person for 30-90 min each.ParticipantsPast and present DPP lifestyle coaches in the healthcare system identified using purposive sampling.ApproachThematic analysis of qualitative data to identify key factors influencing the success of DPP implementation. An iterative consensus process was used to model the relationships among factors.Key resultsWe conducted 33 interviews across 20 clinic sites serving 12 counties. Participants described six key factors as potential barriers or facilitators to implementation, including (1) Broader Context, including the surrounding physical and sociodemographic context; (2) Institutional Context, including finances, infrastructure, and personnel; (3) Program Provision, including curriculum, administration, cost, goals, and visibility; (4) Recruitment Process, including screening and referrals; (5) Lifestyle Coaches, including their characteristics, behaviors, and morale; and (6) Cohort, including group attrition/retention and interpersonal dynamics. These factors were both highly interconnected in their impact on implementation and widely variable across sites within the healthcare system, as illustrated in our multi-level conceptual framework.ConclusionsThis study identified key factors that could serve as barriers or facilitators in the implementation of DPP in large healthcare systems, from the perspective of lifestyle coaches. With further examination, the conceptual model presented here may be used for planning and managing the implementation of group-based behavioral interventions in these settings.
| S-EPMC7280375 | biostudies-literature
Project description:IntroductionIn clinical trials, liraglutide has proven to be an effective drug for the treatment of type 2 diabetes mellitus (T2DM). The real-world effectiveness of liraglutide has been investigated in numerous studies. The aim of this systematic literature review is to collate evidence on the real-world clinical effectiveness of liraglutide.MethodsA review of publications from Medline, EMBASE, the Cochrane Library, and conference proceedings was conducted to identify observational studies that assessed the clinical effectiveness of liraglutide in real-world clinical practice. This review was conducted according to the National Institute of Health and Care Excellence (NICE) guidance. No language or time limits were applied, except to the conference proceedings (2013-2015). Endpoints for data extraction were decided a priori. Study quality appraisal was done for full-text journal articles.ResultsOf 124 publications included in the review, 43 were full-text articles. Liraglutide significantly reduces glycated hemoglobin (HbA1c) within 6 months of initiating treatment (mean change in HbA1c from baseline: -0.9% to -2.2%; HbA1c <7.0%: 29.5-65.0%). The NICE composite endpoint (HbA1c reduction ≥1% and weight reduction ≥3%) was met in 16.9-47.0% of patients with liraglutide treatment. Liraglutide therapy led to a mean change in absolute weight from baseline of -1.3 to -8.65 kg. Liraglutide treatment was well tolerated in patients with T2DM. The rate of occurrence of hypoglycemia with liraglutide monotherapy was ≤0.8%. Hypoglycemia was more common in patients taking antidiabetic medications (0.0-15.2%) together with liraglutide. The beneficial glycemic and weight effect of liraglutide therapy in patients with T2DM was maintained for at least 12 months.ConclusionEvidence from observational studies reflecting real-world clinical practice demonstrates that liraglutide therapy improves glycemic control with a low risk of hypoglycemia, and is associated with significant weight loss in patients with T2DM. These observations are consistent with clinical trial findings.FundingNovo Nordisk A/S, Søborg, Denmark.
| S-EPMC5014786 | biostudies-literature