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Prevalence and correlates of non-adherence to immunosuppressants and to health behaviours in patients after kidney transplantation in Brazil - the ADHERE BRAZIL multicentre study: a cross-sectional study protocol.

ABSTRACT: BACKGROUND:Non-adherence to immunosuppressive therapy is a prevalent risk factor for poor clinical and after kidney transplantation (KT), and has contributed to the lack of improvement in long-term graft survival over the past decade. Understanding the multilevel correlates and risk factors of non-adherence is crucial to determine the optimal level for planning interventions, namely at the patient, health care provider, KT centre, and health care system level. Brazil, having the largest public transplantation program in the world and with regional differences regarding access to health services and service implementation, is in a unique position to study this multilevel approach. Therefore, the Adhere Brazil Study (ADHERE BRAZIL) was designed to assess the prevalence and variability of non-adherence to immunosuppressants and to health behaviours among adult KT recipients in Brazil, and to assess the multilevel correlates of non-adherence to immunosuppressive medication. We describe the rationale, design, and methodology of the ADHERE BRAZIL study. METHODS/DESIGN:This is an observational, cross-sectional, multicentre study that includes 20 Brazilian KT centres. A stratified sampling approach is used, based on strata, with the following characteristics considered: geographical region and transplant activity (number of KTs per year). A random sample of patients (proportional to the size of the centre within each stratum) is selected from each centre. The prevalence of different health behaviours is assessed through self-report. The assessment of multilevel correlates of non-adherence is guided by the ecological model that considers factors at the level of the patient, health-care professional, and transplant centre, using established instruments or instruments developed for this study. Data will be collected over an 18-month period, with information obtained during the regular follow-up visits to the transplant outpatient clinic and directly entered into the Research Electronic Data Capture (RedCap) system. Data entry is performed by a trained professional who is part of the transplant team. The data collection began in December 2015. DISCUSSION:This multicentre study is the first to evaluate multilevel correlates of non-adherence in KT patients and will provide a reliable estimate of non-adherence in Brazilian KT patients. TRIAL REGISTRATION:ClinicalTrials.gov on 10/10/2013, NCT02066935 .

SUBMITTER: Sanders-Pinheiro H

PROVIDER: S-EPMC5819659 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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Prevalence and correlates of non-adherence to immunosuppressants and to health behaviours in patients after kidney transplantation in Brazil - the ADHERE BRAZIL multicentre study: a cross-sectional study protocol.

Sanders-Pinheiro Helady H Colugnati Fernando Antonio Basile FAB Marsicano Elisa Oliveira EO De Geest Sabina S Medina José Osmar Pestana JOP

BMC nephrology 20180220 1

<h4>Background</h4>Non-adherence to immunosuppressive therapy is a prevalent risk factor for poor clinical and after kidney transplantation (KT), and has contributed to the lack of improvement in long-term graft survival over the past decade. Understanding the multilevel correlates and risk factors of non-adherence is crucial to determine the optimal level for planning interventions, namely at the patient, health care provider, KT centre, and health care system level. Brazil, having the largest ...[more]

PMID: 29463231

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Project description:BACKGROUND: The extent to which patients follow treatments as prescribed is pivotal to treatment success. An exceptionally high level (> 95%) of HIV medication adherence is required to suppress viral replication and protect the immune system and a similarly high level (> 80%) of adherence has also been suggested in order to benefit from prescribed exercise programmes. However, in clinical practice, adherence to both often falls below the desirable level. This project aims to investigate a wide range of psychological and personality factors that may lead to adherence/non-adherence to medical treatment and exercise programmes. METHODS: HIV positive patients who are referred to the physiotherapist-led 10-week exercise programme as part of the standard care are continuously recruited. Data on social cognitive variables (attitude, intention, subjective norms, self-efficacy, and outcome beliefs) about the goal and specific behaviours, selected personality factors, perceived quality of life, physical activity, self-reported adherence and physical assessment are collected at baseline, at the end of the exercise programme and again 3 months later. The project incorporates objective measures of both exercise (attendance log and improvement in physical measures such as improved fitness level, weight loss, improved circumferential anthropometric measures) and medication adherence (verified by non-invasive hair analysis). DISCUSSION: The novelty of this project comes from two key aspects, complemented with objective information on exercise and medication adherence. The project assesses beliefs about both the underlying goal such as following prescribed treatment; and about the specific behaviours such as undertaking the exercise or taking the medication, using both implicit and explicit assessments of patients' beliefs and attitudes. We predict that i) the way people think about the underlying goal of their treatments explains medication and exercise behaviours over and above the effects of the behaviour-specific thinking and ii) the relationship between adherence to exercise and to medical treatment is stronger among those with more favourable views about the goal. Results from this study should identify the key contributing factors to inform subsequent adherence research and afford a more streamlined assessment matrix. The project also aims to inform patient care practices. UK CLINICAL RESEARCH NETWORK REGISTRATION NUMBER: UKCRN 7842.

Project description:IntroductionIn heart transplant recipients (HTRs), non-adherence (NA) to immunosuppressive (IS) medication and to recommended lifestyle behaviours are a common phenomenon and associated with higher risk of allograft rejection, organ loss and mortality. Risk factors for NA are highly diverse and still insufficiently researched. Precise measures of NA and an accurate understanding of its aetiology are of undisputable importance to detect patients at risk and intervene accordingly. The aim of this study is to assess the accuracy and concordance of different measures for NA as well as to determine potential risk factors.Methods and analysisThis is a single-centre prospective observational trial. HTRs who are at least aged 18 are no less than 6 months post-transplant and receive tacrolimus (Prograf or Advagraf), cyclosporine (Sandimmun) or everolimus (Certican) as their prescribed IS medication are eligible for participation. We only include patients during the phase of medication implementation. At study enrolment, we assess depression, health-related quality of life, self-efficacy, social support, attachment, experiences and attitudes towards IS medication, emotional responses after transplantation, satisfaction with information about IS medication and perceptions and beliefs about medications. We further ask patients to rate their lifestyle behaviours concerning alcohol, smoking, diet, physical activity, sun protection and appointment keeping via questionnaires. Three different measurement methods for NA are applied at T0: self-reports, physician's estimates and IS trough levels. NA is monitored prospectively using an electronic multicompartment pillbox (MEMS, VAICA) over a 3-month period. Meanwhile, participants receive phone calls every second week to obtain additional self-reports, resulting in a total of seven measurement points.Ethics and disseminationThe study was approved by the Clinical Ethics Committee of the University Hospital Erlangen (Friedrich-Alexander-University, Erlangen-Nürnberg). Written informed consent is attained from all participants. The results of this study will be published in peer-reviewed journals and presented at conferences.Trial registration numberDRKS00020496.

Project description:BACKGROUND:Insufficient physical activity, short sleep duration, and excessive recreational screen time are increasing globally. Currently, there are little to no data describing prevalences and correlates of movement behaviours among children in low-middle-income countries. The few available reports do not include both urban and rural respondents, despite the large proportion of rural populations in low-middle-income countries. We compared the prevalence of meeting 24-h movement guidelines and examined correlates of meeting the guidelines in a sample of urban and rural Mozambican schoolchildren. METHODS:This is cross-sectional study of 9-11?year-old children (n?=?683) recruited from 10 urban and 7 rural schools in Mozambique. Moderate- to vigorous-intensity physical activity (MVPA) and sleep duration were measured by waist-worn Actigraph GT3X+ accelerometers. Accelerometers were worn 24?h/day for up to 8 days. Recreational screen time was self-reported. Potential correlates of meeting 24-h movement guidelines were directly measured or obtained from validated items of context-adapted questionnaires. Multilevel multivariable logit models were used to determine the correlates of movement behaviours. Meeting 24-h movement guidelines was defined as ?60?min/day of MVPA, ?2?h/day of recreational screen time, and between 9 and 11?h/night of sleep. RESULTS:More rural (17.7%) than urban (3.6%) children met all three 24-h movement guidelines. Mean MVPA was lower (82.9?±?29.5?min/day) among urban than rural children (96.7?±?31.8?min/day). Rural children had longer sleep duration (8.9?±?0.7?h/night) and shorter recreational screen time (2.7?±?1.9?h/day) than their urban counterparts (8.7?±?0.9?h/night and 5.0?±?2.3?h/day respectively). Parental education (OR: 0.37; CI: 0.16-0.87), school location (OR: 0.21; CI: 0.09-0.52), and outdoor time (OR: 0.67; CI: 0.53-0.85) were significant correlates of meeting all three 24-h movement guidelines. CONCLUSIONS:Prevalence and correlates of meeting movement guidelines differed between urban and rural schoolchildren in Mozambique. On average, both groups had higher daily MVPA minutes, shorter sleep duration, and higher recreational screen time than the 24-h movement guidelines recommend. These findings (e.g., higher than recommended mean daily MVPA minutes) differ from those from high-income countries and highlight the need to sample from both urban and rural areas.

Project description:ObjectivesIt is important that the outcomes of advance care planning (ACP) conversations are documented and available at the point of care. Advance care directives (ACDs) are a subset of ACP documentation and refer to structured documents that are completed and signed by competent adults. Other ACP documentation includes informal documentation by the person or on behalf of the person by someone else (eg, clinician, family). The primary objectives were to describe the prevalence and correlates of ACDs among Australians aged 65 and over accessing health and residential aged care services. The secondary aim was to describe the prevalence of other ACP documentation.Design and settingA prospective multicentre health record audit in general practices (n=13), hospitals (n=12) and residential aged care facilities (RACFs; n=26).Participants503 people attending general practice, 574 people admitted to hospitals and 1208 people in RACFs.Primary and secondary outcome measuresPrevalence of one or more ACDs; prevalence of other ACP documentation.Results29.8% of people had at least one ACD on file. The majority were non-statutory documents (20.9%). ACD prevalence was significantly higher in RACFs (47.7%) than hospitals (15.7%) and general practices (3.2%) (p<0.001), and varied across jurisdictions. Multivariate logistic regression showed that the odds of having an ACD were positively associated with greater functional impairment and being in an RACF or hospital compared with general practice. 21.6% of people had other ACP documentation.ConclusionsIn this study, 30% of people had ACDs accessible and a further 20% had other ACP documentation, suggesting that approximately half of participants had some form of ACP. Correlates of ACD completion were greater impairment and being in an RACF or hospital. Greater efforts to promote and standardise ACDs across jurisdictions may help to assist older people to navigate and complete ACDs and to receive care consistent with their preferences.Trial registration numberACTRN12617000743369.

Dataset Information

Prevalence and correlates of non-adherence to immunosuppressants and to health behaviours in patients after kidney transplantation in Brazil - the ADHERE BRAZIL multicentre study: a cross-sectional study protocol.

Publications

Prevalence and correlates of non-adherence to immunosuppressants and to health behaviours in patients after kidney transplantation in Brazil - the ADHERE BRAZIL multicentre study: a cross-sectional study protocol.

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