The devil is in the detail - a multifactorial intervention to reduce blood pressure in co-existing diabetes and chronic kidney disease: a single blind, randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>About 30-60% of individuals are non-adherent to their prescribed medications and this risk increases as the number of prescribed medications increases. This paper outlines the development of a consumer-centred <it>Me</it>dicine <it>S</it>elf-<it>M</it>anagement <it>I</it>ntervention (MESMI), designed to improve blood pressure control and medication adherence in consumers with diabetes and chronic kidney disease recruited from specialist outpatients' clinics.</p> <p>Methods</p> <p>We developed a multifactorial intervention consisting of Self Blood Pressure Monitoring (SBPM), medication review, a twenty-minute interactive Digital Versatile Disc (DVD), and follow-up support telephone calls to help consumers improve their blood pressure control and take their medications as prescribed. The intervention is novel in that it has been developed from analysis of consumer and health professional views, and includes consumer video exemplars in the DVD. The primary outcome measure was a drop of 3-6 mmHg systolic blood pressure at three months after completion of the intervention. Secondary outcome measures included: assessment of medication adherence, medication self-efficacy and general wellbeing. Consumers' adherence to their prescribed medications was measured by manual pill count, self-report of medication adherence, and surrogate biochemical markers of disease control.</p> <p>Discussion</p> <p>The management of complex health problems is an increasing component of health care practice, and requires interventions that improve patient outcomes. We describe the preparatory work and baseline data of a single blind, randomized controlled trial involving consumers requiring cross-specialty care with a follow-up period extending to 12 months post-baseline.</p> <p>Trial Registration</p> <p>The trial was registered with the Australian and New Zealand Clinical Trials Register (ACTRN12607000044426).</p

Action-specific Cognitions of Planned and Preparatory Behaviors of Condom Use among Dutch Adolescents

Many adolescents fail to use condoms, even when they are motivated to do so. An important reason for their failure to use condoms is that they do not prepare themselves for potential sexual encounters. The present study examined the circumstances under which Dutch adolescents were likely to prepare themselves for condom use (buying and carrying). In a sample of 399 secondary school students, including students with and without sexual experience, it was found that intended condom use was not sufficient to ensure that adolescents plan and prepare for condom use. It was found that having the goal of condom use did not necessarily result in preparatory behavior, such as condom buying and condom carrying. The data showed that action-specific social-cognitive factors of preparatory behavior explained preparatory behavior, beyond the decision to use condoms. This suggests that interventions aimed at promoting condom use should focus not only on condom use itself, but should also motivate and encourage adolescents to buy and carry condoms

Impact of a parent-child sexual communication campaign: results from a controlled efficacy trial of parents

<p>Abstract</p> <p>Background</p> <p>Prior research supports the notion that parents have the ability to influence their children's decisions regarding sexual behavior. Yet parent-based approaches to curbing teen pregnancy and STDs have been relatively unexplored. The Parents Speak Up National Campaign (PSUNC) is a multimedia campaign that attempts to fill this void by targeting parents of teens to encourage parent-child communication about waiting to have sex. The campaign follows a theoretical framework that identifies cognitions that are targeted in campaign messages and theorized to influence parent-child communication. While a previous experimental study showed PSUNC messages to be effective in increasing parent-child communication, it did not address how these effects manifest through the PSUNC theoretical framework. The current study examines the PSUNC theoretical framework by 1) estimating the impact of PSUNC on specific cognitions identified in the theoretical framework and 2) examining whether those cognitions are indeed associated with parent-child communication</p> <p>Methods</p> <p>Our study consists of a randomized efficacy trial of PSUNC messages under controlled conditions. A sample of 1,969 parents was randomly assigned to treatment (PSUNC exposure) and control (no exposure) conditions. Parents were surveyed at baseline, 4 weeks, 6 months, 12 months, and 18 months post-baseline. Linear regression procedures were used in our analyses. Outcome variables included self-efficacy to communicate with child, long-term outcome expectations that communication would be successful, and norms on appropriate age for sexual initiation. We first estimated multivariable models to test whether these cognitive variables predict parent-child communication longitudinally. Longitudinal change in each cognitive variable was then estimated as a function of treatment condition, controlling for baseline individual characteristics.</p> <p>Results</p> <p>Norms related to appropriate age for sexual initiation and outcome expectations that communication would be successful were predictive of parent-child communication among both mothers and fathers. Treatment condition mothers exhibited larger changes than control mothers in both of these cognitive variables. Fathers exhibited no exposure effects.</p> <p>Conclusions</p> <p>Results suggest that within a controlled setting, the "wait until older norm" and long-term outcome expectations were appropriate cognitions to target and the PSUNC media materials were successful in impacting them, particularly among mothers. This study highlights the importance of theoretical frameworks for parent-focused campaigns that identify appropriate behavioral precursors that are both predictive of a campaign's distal behavioral outcome and sensitive to campaign messages.</p

Healthcare professionals' intentions and behaviours: A systematic review of studies based on social cognitive theories

<p>Abstract</p> <p>Background</p> <p>There is an important gap between the implications of clinical research evidence and the routine clinical practice of healthcare professionals. Because individual decisions are often central to adoption of a clinical-related behaviour, more information about the cognitive mechanisms underlying behaviours is needed to improve behaviour change interventions targeting healthcare professionals. The aim of this study was to systematically review the published scientific literature about factors influencing health professionals' behaviours based on social cognitive theories. These theories refer to theories where individual cognitions/thoughts are viewed as processes intervening between observable stimuli and responses in real world situations.</p> <p>Methods</p> <p>We searched psycINFO, MEDLINE, EMBASE, CIHNAL, Index to theses, PROQUEST dissertations and theses and Current Contents for articles published in English only. We included studies that aimed to predict healthcare professionals' intentions and behaviours with a clear specification of relying on a social cognitive theory. Information on percent of explained variance (R²) was used to compute the overall frequency-weighted mean R²to evaluate the efficacy of prediction in several contexts and according to different methodological aspects. The cognitive factors most consistently associated with prediction of healthcare professionals' intention and behaviours were documented.</p> <p>Results</p> <p>Seventy eight studies met the inclusion criteria. Among these studies, 72 provided information on the determinants of intention and 16 prospective studies provided information on the determinants of behaviour. The theory most often used as reference was the Theory of Reasoned Action (TRA) or its extension the Theory of Planned Behaviour (TPB). An overall frequency-weighted mean R²of 0.31 was observed for the prediction of behaviour; 0.59 for the prediction of intention. A number of moderators influenced the efficacy of prediction; frequency-weighted mean R²varied from 0.001 to 0.58 for behaviour and 0.19 to 0.81 for intention.</p> <p>Conclusion</p> <p>Our results suggest that the TPB appears to be an appropriate theory to predict behaviour whereas other theories better capture the dynamic underlying intention. In addition, given the variations in efficacy of prediction, special care should be given to methodological issues, especially to better define the context of behaviour performance.</p

Do interventions to improve adherence to antiretroviral therapy recognise diversity? A systematic review

People living with HIV (PLWH) are often culturally and linguistically diverse populations; these differences are associated with differing barriers to antiretroviral therapy (ART) adherence. Cultural competence measures the extent to which trial design recognises this diversity. This systematic review aimed to determine whether adherence trial participants represent the diversity of PLWH. Randomised Controlled Trials in Organisation for Economic Co-operation and Development countries to improve ART adherence were eligible. We searched MEDLINE, EMBASE, and Cochrane Database of Systematic Reviews. For all included trials, we searched for their development, testing and evaluation studies. We compared trial participant characteristics with nationally reported PLWH data. We appraised trial cultural competence against ten criteria; scoring each criterion as 0, 1 or 2 indicating cultural blindness, pre-competence or competence respectively. For 80 included trials, a further 13 studies presenting development/testing/evaluation data for the included trials were identified. Only one of the 80 included studies reported trial participants representative of the country's population of PLWH. The median (IQ) cultural competence score was 2.5 (1.0, 4.0) out of 20. HIV adherence trial participants are not reflective of the population with HIV, which may be due to limited adoption of culturally competent research methods

Self-management education for adults with poorly controlled epilepsy (SMILE (UK)): statistical, economic and qualitative analysis plan for a randomised controlled trial

BACKGROUND: There is a need to test the effectiveness of new educational interventions for people with poorly controlled epilepsy. The SMILE (self-management education for adults with poorly controlled epilepsy) trial evaluates a complex service intervention that involves a 2-day self-management course with the aim of improving quality of life and clinical outcomes. This article describes the statistical, economic, and qualitative analysis plan for the trial. METHODS AND DESIGN: SMILE is a pragmatic, parallel design, two-arm, multi-centre randomised controlled superiority trial of a group-based interactive course compared with treatment as usual for people who have experienced two or more seizures in the past 12 months. RESULTS: A summary of the objectives and design of the trial are reported as well as the manner in which the data will be summarised and inferentially analysed. This includes the type of modelling that will be employed for each of the primary and secondary outcomes and the methods by which the assumptions of these models will be checked. Strategies are described for handling clustering of outcome data, missing observations, and treatment non-compliance. CONCLUSION: This update to the previously published trial protocol provides a description of the trial analysis which is transparent and specified before any outcome data are available. It also provides guidance to those planning the analysis of similar trials. TRIAL REGISTRATION: Current Controlled Trials ISRCTN57937389; date assigned: 27 March 2013

Evaluation of a real-time virtual intervention to empower persons living with HIV to use therapy self-management: study protocol for an online randomized controlled trial

Background: Living with HIV makes considerable demands on a person in terms of self-management, especially as regards adherence to treatment and coping with adverse side-effects. The online HIV Treatment, Virtual Nursing Assistance and Education (Virus de I'immunodeficience Humaine-Traitement Assistance Virtuelle Infirmiere et Enseignement; VIH-TAVIE (TM)) intervention was developed to provide persons living with HIV (PLHIV) with personalized follow-up and real-time support in managing their medication intake on a daily basis. An online randomized controlled trial (RCT) will be conducted to evaluate the efficacy of this intervention primarily in optimizing adherence to combination anti-retroviral therapy (ART) among PLHIV.Methods/design: A convenience sample of 232 PLHIV will be split evenly and randomly between an experimental group that will use the web application, and a control group that will be handed a list of websites of interest. Participants must be aged 18 years or older, have been on ART for at least 6 months, and have internet access. The intervention is composed of four interactive computer sessions of 20 to 30 minutes hosted by a virtual nurse who engages the PLHIV in a skills-learning process aimed at improving self-management of medication intake. Adherence constitutes the principal outcome, and is defined as the intake of at least 95% of the prescribed tablets. The following intermediary measures will be assessed: self-efficacy and attitude towards antiretroviral medication, symptom-related discomfort, and emotional support. There will be three measurement times: baseline (T0), after 3 months (T3) and 6 months (T6) of baseline measurement. The principal analyses will focus on comparing the two groups in terms of treatment adherence at the end of follow-up at T6. An intention-to-treat (ITT) analysis will be carried out to evaluate the true value of the intervention in a real context.Discussion: Carrying out this online RCT poses various challenges in terms of recruitment, ethics, and data collection, including participant follow-up over an extended period. Collaboration between researchers from clinical disciplines (nursing, medicine), and experts in behavioral sciences information technology and media will be crucial to the development of innovative solutions to supplying and delivering health services