Lorraine Martin-Stacey

The face of equipoise - delivering a structured education programme within a randomized controlled trial: qualitative study

BackgroundIn trials of behavioural interventions, the individuals who deliver the intervention are in a position of key influence on the success of the trial. Their fidelity to the intervention is crucial. Yet little is understood about the experiences of this group of trial personnel. This study aimed to investigate the views and experiences of educators who delivered a structured education intervention to people with type 2 diabetes, which incorporated training in self-monitoring of either blood glucose (SMBG) or urine glucose (SMUG) as part of a randomized controlled trial (RCT).MethodsEducators’ views were explored through focus groups before and after training (N = 18) and approximately 1 year into the trial (N = 14), and semi-structured telephone interviews at approximately 2 years (N = 7). Analysis was based on the constant comparative method.ResultsEducators held preferences regarding the intervention variants; thus, they were not in individual equipoise. Training raised awareness of preferences and their potential to impact on delivery. Educators were confident in their unbiased delivery, but acknowledged the challenges involved. Concealing their preferences was helped by a sense of professionalism, the patient-centred nature of the intervention, and concessions in the trial protocol (enabling participants to swap monitoring methods if needed). Commitment to unbiased delivery was explained through a desire for evidence-based knowledge in the contentious area of SMBG.ConclusionsThe findings provide insight into a previously unexplored group of trial personnel - intervention deliverers in trials of behavioural interventions - which will be useful to those designing and running similar trials. Rather than individual equipoise, it is intervention deliverers’ awareness of personal preferences and their potential impact on the trial outcome that facilitates unbiased delivery. Further, awareness of community equipoise, the need for evidence, and relevance to the individual enhance commitment to the RCT.Trial registrationISRCTN95696668

A study protocol for a pilot randomised trial of a structured education programme for the self-management of type 2 diabetes for adults with intellectual disabilities

BackgroundThe need for structured education programmes for type 2 diabetes is a high priority for many governments around the world. One such national education programme in the United Kingdom is the DESMOND Programme, which has been shown to be robust and effective for patients in general. However, these programmes are not generally targeted to people with intellectual disabilities (ID), and robust evidence on their effects for this population is lacking. We have adapted the DESMOND Programme for people with ID and type 2 diabetes to produce an amended programme known as DESMOND-ID.This protocol is for a pilot trial to determine whether a large-scale randomised trial is feasible, to test if DESMOND-ID is more effective than usual care in adults with ID for self-management of their type 2 diabetes, in particular as a means to reduce glycated haemoglobin (Hb1Ac), improve psychological wellbeing and quality of life and promote a healthier lifestyle. This protocol describes the rationale, methods, proposed analysis plan and organisational and administrative details.Methods/DesignThis trial is a two arm, individually randomised, pilot trial for adults with ID and type 2 diabetes, and their family and/or paid carers. It compares the DESMOND-ID programme with usual care. Approximately 36 adults with mild to moderate ID will be recruited from three countries in the United Kingdom. Family and/or paid carers may also participate in the study. Participants will be randomly assigned to one of two conditions using a secure computerised system with robust allocation concealment. A range of data will be collected from the adults with ID (biomedical, psychosocial and self-management strategies) and from their carers. Focus groups with all the participants will assess the acceptability of the intervention and the trial.DiscussionThe lack of appropriate structured education programmes and educational materials for this population leads to secondary health conditions and may lead to premature deaths. There are significant benefits to be gained globally, if structured education programmes are adapted and shown to be successful for people with ID and other cognitive impairments.Trial registrationRegistered with International Standard Randomised Controlled Trial (identifier: ISRCTN93185560) on 10 November 2014.

Does self monitoring of blood glucose as opposed to urinalysis provide additional benefit in patients newly diagnosed with type 2 diabetes receiving structured education? The DESMOND SMBG randomised controlled trial protocol

BackgroundThe benefit of self-monitoring of blood glucose (SMBG) in people with type 2 diabetes on diet or oral agents other than sulphonylureas remains uncertain. Trials of interventions incorporating education about self-monitoring of blood glucose have reported mixed results. A recent systematic review concluded that SMBG was not cost-effective. However, what was unclear was whether a cheaper method of self-monitoring (such as urine glucose monitoring) could produce comparable benefit and patient acceptability for less cost.Methods/DesignThe DESMOND SMBG trial is comparing two monitoring strategies (blood glucose monitoring and urine testing) over 18 months when incorporated into a comprehensive self-management structured education programme. It is a multi-site cluster randomised controlled trial, conducted across 8 sites (7 primary care trusts) in England, UK involving individuals with newly diagnosed Type 2 diabetes.The trial has 80% power to demonstrate equivalence in mean HbA1c (the primary end-point) at 18 months of within ± 0.5% assuming 20% drop out and 20% non-consent. Secondary end-points include blood pressure, lipids, body weight and psychosocial measures as well as a qualitative sub-study.Practices were randomised to one of two arms: participants attend a DESMOND programme incorporating a module on self-monitoring of either urine or blood glucose. The programme is delivered by accredited educators who received specific training about equipoise. Biomedical data are collected and psychosocial scales completed at baseline, and 6, 12, and 18 months post programme. Qualitative research with participants and educators will explore views and experiences of the trial and preferences for methods of monitoring.DiscussionThe DESMOND SMBG trial is designed to provide evidence to inform the debate about the value of self-monitoring of blood glucose in people with newly diagnosed type 2 diabetes. Strengths include a setting in primary care, a cluster design, a health economic analysis, a comparison of different methods of monitoring while controlling for other components of training within the context of a quality assured structured education programme and a qualitative sub-study.Trial registrationISRCTN: ISRCTN95696668.

Using an interactive DVD about type 2 diabetes and insulin therapy in a UK South Asian community and in patient education and healthcare provider training

OBJECTIVES To develop and pilot-test the feasibility and effectiveness of an interactive DVD about misconceptions within South Asian communities regarding insulin treatment in type 2 diabetes, for educating patients and community members and training healthcare providers. METHODS The project setting was a South Asian (mainly Indian) community in Leicester, UK. Qualitative evidence from our previous studies was used to inform the content of the DVD script and accompanying resources. The intervention involved three components: facilitating DVD viewings for people with/without diabetes in community settings; training healthcare providers involved in managing South Asian patients with diabetes in primary care; and using the DVD and resources in primary care patient consultations. Evaluation involved a range of approaches including face-to-face interviews, telephone feedback and questionnaires. RESULTS Analysis of questionnaires and qualitative feedback from community participants showed some significant changes in attitudes and understanding about insulin and high acceptability of the DVD. Healthcare providers who attended the training found it informative and perceived the DVD and visual resources as potentially useful for facilitating acceptance of insulin. Primary care patient recruitment was challenging, but participants described the DVD as an acceptable and informative way of learning about insulin therapy. CONCLUSION The DVD intervention was effective and feasible at community and healthcare provider levels. PRACTICE IMPLICATIONS Although based on a small sample, at patient level our findings suggested that the DVD worked at different levels helping some to accept the need for insulin and others to consolidate a decision to commence this treatment. Consideration needs to be given to patient engagement strategies for implementation in primary care consultations.

Pilot feasibility study examining a structured self‐management diabetes education programme, DESMOND‐ID, targeting HbA1c in adults with intellectual disabilities

To report on the outcomes of a pilot feasibility study of a structured self‐management diabetes education programme targeting HbA1c.

‘A Safer Ramadan’: developing an integrated approach to support safer fasting and feasting for people with type 2 diabetes

In the United Kingdom, it is estimated that there are over 300 000 Muslim people with diabetes. Observance of Ramadan is an integral part of being a Muslim that involves abstinence from food and drink from dawn till dusk. In the UK over the next 10 years, Ramadan will fall in the heart of the summer months, resulting in longer fasting periods. For people with diabetes fasting can be problematic, yet few individuals receive advice from health care professionals on how to manage their diabetes during the Ramadan period. A ‘whole systems’ approach, involving community awareness, health care professional training and patient education, was used to develop and implement an educational intervention to address the needs of individuals with type 2 diabetes during the Ramadan period.