Development and Evaluation of a Psychosocial Intervention for Children and Teenagers Experiencing Diabetes (DEPICTED): a protocol for a cluster randomised controlled trial of the effectiveness of a communication skills training programme for healthcare professionals working with young people with type 1 diabetes

Background Diabetes is the third most common chronic condition in childhood and poor glycaemic control leads to serious short-term and life-limiting long-term complications. In addition to optimal medical management, it is widely recognised that psychosocial and educational factors play a key role in improving outcomes for young people with diabetes. Recent systematic reviews of psycho-educational interventions recognise the need for new methods to be developed in consultation with key stakeholders including patients, their families and the multidisciplinary diabetes healthcare team. Methods/design Following a development phase involving key stakeholders, a psychosocial intervention for use by paediatric diabetes staff and not requiring input from trained psychologists has been developed, incorporating a communication skills training programme for health professionals and a shared agenda-setting tool. The effectiveness of the intervention will be evaluated in a cluster-randomised controlled trial (RCT). The primary outcome, to be measured in children aged 4-15 years diagnosed with type 1 diabetes for at least one year, is the effect on glycaemic control (HbA1c) during the year after training of the healthcare team is completed. Secondary outcomes include quality of life for patients and carers and cost-effectiveness. Patient and carer preferences for service delivery will also be assessed. Twenty-six paediatric diabetes teams are participating in the trial, recruiting a total of 700 patients for evaluation of outcome measures. Half the participating teams will be randomised to receive the intervention at the beginning of the trial and remaining centres offered the training package at the end of the one year trial period. Discussion The primary aim of the trial is to determine whether a communication skills training intervention for specialist paediatric diabetes teams will improve clinical and psychological outcomes for young people with type 1 diabetes. Previous research indicates the effectiveness of specialist psychological interventions in achieving sustained improvements in glycaemic control. This trial will evaluate an intervention which does not require the involvement of trained psychologists, maximising the potential feasibility of delivery in a wider NHS context. Trial registration Current Controlled Trials ISRCTN61568050

Patients' understandings of heart attack: implications for prevention of recurrence

Patients' willingness to undertake secondary preventive strategies following heart attack are likely to be affected by their understandings of their condition. This qualitative study explored patients' understandings of heart attack in order to contribute to the design of effective secondary prevention services. In-depth interviews were conducted with 25 patients with myocardial infarction (MI). These data indicate that information received from health professionals encourages patients to view heart attack as an acute event rather than a symptom of a chronic condition and that this understanding provides patients with low motivation for long-term lifestyle change. Patients may benefit from understanding a heart attack as an acute symptom of an underlying disease process which long-term medication and behavioural change can help to check. In order to achieve this, health professionals need to examine patients' understandings of their heart attack and recovery and to provide information about lifestyle which engages with these understandings

The effect of a brief action planning intervention on adherence to double-blind study medication, compared to a standard trial protocol, in the Atorvastatin in Factorial with Omega EE90 Risk Reduction in Diabetes (AFORRD) clinical trial: a cluster randomised sub-study

Aims: Clinical trial patients are highly motivated but may encounter difficulty in taking study medication regularly when treatment burden is substantial. We assessed a brief behavioural intervention, given in addition to a standard trial protocol. Methods: We performed a two-arm adherence sub-study, within a twelve-month randomised controlled drug trial evaluating the impact of statin and/or omega-3 EE90 treatment in 800 patients with type 2 diabetes, in 59 United Kingdom general practices cluster-randomised to action-planning or control groups. The former delivered an initial written exercise prompting participants to formulate action-plans to take study medication regularly, with brief nurse encouragement to use actionplans at later visits, whilst the latter followed the standard trial protocol. The primary outcome was proportion of days on which study medication were taken as intended measured by electronic medication containers. Results: Adjusted mean (95% CI) proportion of days with medication taken as intended was 79.3% (76.3% to 82.3%) for the 30 action-planning practices (321 participants), compared with 78.5% (75.8% to 81.1%) for the 29 control group practices (479 participants, with a mean intervention effect of 0.9% (95%CI -3.1% to +4.9%, p=0.67). Adjusted odds ratios for ≥80% trial medication adherence for actionplanning compared with control practices were 1.29 (0.90 to 1.84) and 1.38 (0.96 to 1.99) respectively. Conclusions: Low-intensity action-planning interventions used alone are unlikely to have a clinically important impact on medication adherence. These findings, do not exclude their contribution, as part of a multifactorial intervention, to improving treatment adherence

Paediatric nursing and research ethics: is there a conflict?

•This paper briefly outlines the major ethical issues which need to be considered when conducting paediatric research.•An overview of ethical theories and principles will highlight the difficulties which may be experienced when making decisions about children's competency to consent to participate in research.•The congruency of the paediatric nurse as ‘researcher’ and ‘practitioner’ will be examined. Does the nurse involved in paediatric research experience a conflict between a commitment to research and safeguarding the interests and well-being of the child