Trials
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Randomized Controlled Trial Multicenter Study
An intervention to improve mental health care for conflict-affected forced migrants in low-resource primary care settings: a WHO MhGAP-based pilot study in Sri Lanka (COM-GAP study).
Inadequacy in mental health care in low and middle income countries has been an important contributor to the rising global burden of disease. The treatment gap is salient in resource-poor settings, especially when providing care for conflict-affected forced migrant populations. Primary care is often the only available service option for the majority of forced migrants, and integration of mental health into primary care is a difficult task. The proposed pilot study aims to explore the feasibility of integrating mental health care into primary care by providing training to primary care practitioners serving displaced populations, in order to improve identification, treatment, and referral of patients with common mental disorders via the World Health Organization Mental Health Gap Action Programme (mhGAP). ⋯ In post-conflict Sri Lanka, an important need exists to provide adequate mental health care to conflict-affected internally displaced persons who are returning to their areas of origin after prolonged displacement. The proposed study will act as a local demonstration project, exploring the feasibility of formulating a larger-scale intervention study in the future, and is envisaged to provide information on engaging PCP, and data on training and evaluation including economic costs, patient recruitment, and acceptance and follow-up rates. The study should provide important information on the WHO mhGAP intervention guide to add to the growing evidence base of its implementation.
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Randomized Controlled Trial
The effect of Baduanjin exercise for physical and psychological wellbeing of college students: study protocol for a randomized controlled trial.
The physical and mental health of college students tends to continuously decline around the world. Since they are in a significant transition period which presents opportunities and challenges in health promotion, it is important to improve their health in this period. As a traditional Chinese exercise form which combines movements with breath and mind, Baduanjin may be one of the selectable effective exercises. However, evidence of Baduanjin exercise for college students has not been completely established. The primary aim of this trial is to evaluate the effectiveness and safety of Baduanjin exercise for physical and mental health of college students through a rigorous randomization, parallel-controlled design. ⋯ This protocol presents an objective design of a randomized, single-blind trial that aims to evaluate the effectiveness and safety of Baduanjin exercise for physical and mental health of college students. If the outcome is positive, the results will provide higher-quality evidence to better inform the college students regarding their selection about whether to receive such exercise.
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Randomized Controlled Trial
A tailored implementation intervention to implement recommendations addressing polypharmacy in multimorbid patients: study protocol of a cluster randomized controlled trial.
Multimorbid patients frequently receive complex medication regimens and are at higher risk for adverse drug reactions and hospitalisations. Managing patients with polypharmacy is demanding, because it requires coordination of multiple prescribers and intensive monitoring. Three evidence-based recommendations addressing polypharmacy in primary care are structured medication counselling, use of medication lists and medication reviews to avoid potentially inappropriate medication (PIM). Although promising to improve patient outcomes, these recommendations are not well implemented in German routine care. Implementation of guidelines is often hindered by specific "determinants of change". "Tailored" interventions are designed to specifically address previously identified determinants. This study examines a tailored intervention to implement the aforementioned recommendations into German primary care practices. This study is part of the European Tailored Interventions for Chronic Diseases project, which aims at contributing knowledge about the methods used for tailoring. ⋯ This study will contribute knowledge about the feasibility of implementing recommendations for managing patients with polypharmacy in primary care practices. Additionally, this study will contribute knowledge about methods for tailoring of implementation interventions.
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Randomized Controlled Trial Multicenter Study Comparative Study
Protocol for the New Medicine Service Study: a randomized controlled trial and economic evaluation with qualitative appraisal comparing the effectiveness and cost effectiveness of the New Medicine Service in community pharmacies in England.
Medication non-adherence is considered an important cause of morbidity and mortality in primary care. This study aims to determine the effectiveness, cost effectiveness and acceptability of a complex intervention delivered by community pharmacists, the New Medicine Service (NMS), compared with current practice in reducing non-adherence to, and problems with, newly prescribed medicines for chronic conditions. ⋯ At the time of submission of this article, 58 community pharmacies have been recruited and the interventions are being delivered. Analysis has not yet been undertaken.
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The burden of cardiovascular disease is rising in sub-Saharan Africa with hypertension being the main risk factor. However, context-specific evidence on effective interventions for primary prevention of cardiovascular diseases in resource-poor settings is limited. This study aims to evaluate the feasibility and cost-effectiveness of one such intervention--the "Sustainable model for cardiovascular health by adjusting lifestyle and treatment with economic perspective in settings of urban poverty". ⋯ The outcomes of the study will be disseminated to local policy makers and health planners.