"What's the Point?": Understanding Why People With Type 2 Diabetes Decline Structured Education.

Structured diabetes education (SDE) is an evidence-based intervention that supports self-management in people with type 2 diabetes. In the United Kingdom, health care providers working in primary care settings are responsible for referring people with type 2 diabetes to SDE programs. However, national audits record a high percentage of nonattenders. We explored the personal experience of living with type 2 diabetes that led to individuals declining invitations to attend SDE programs. The themes suggested that emotional, cognitive, and social issues related to diagnosis and living with diabetes may be responsible for declining to attend SDE and that these factors may be masked by explanations of practical barriers. A person-centered approach to understanding the personal meaning of being diagnosed and living with type 2 diabetes may help to identify individuals' psychosocial barriers to attending SDE.

Structured lifestyle education for people with schizophrenia, schizoaffective disorder and first-episode psychosis (STEPWISE): randomised controlled trial.

BACKGROUND: Obesity is a major challenge for people with schizophrenia.AimsWe assessed whether STEPWISE, a theory-based, group structured lifestyle education programme could support weight reduction in people with schizophrenia. METHOD: In this randomised controlled trial (study registration: ISRCTN19447796), we recruited adults with schizophrenia, schizoaffective disorder or first-episode psychosis from ten mental health organisations in England. Participants were randomly allocated to the STEPWISE intervention or treatment as usual. The 12-month intervention comprised four 2.5 h weekly group sessions, followed by 2-weekly maintenance contact and group sessions at 4, 7 and 10 months. The primary outcome was weight change after 12 months. Key secondary outcomes included diet, physical activity, biomedical measures and patient-related outcome measures. Cost-effectiveness was assessed and a mixed-methods process evaluation was included. RESULTS: Between 10 March 2015 and 31 March 2016, we recruited 414 people (intervention 208, usual care 206) with 341 (84.4%) participants completing the trial. At 12 months, weight reduction did not differ between groups (mean difference 0.0 kg, 95% CI -1.6 to 1.7, P = 0.963); physical activity, dietary intake and biochemical measures were unchanged. STEPWISE was well-received by participants and facilitators. The healthcare perspective incremental cost-effectiveness ratio was £246 921 per quality-adjusted life-year gained. CONCLUSIONS: Participants were successfully recruited and retained, indicating a strong interest in weight interventions; however, the STEPWISE intervention was neither clinically nor cost-effective. Further research is needed to determine how to manage overweight and obesity in people with schizophrenia.Declaration of interestR.I.G.H. received fees for lecturing, consultancy work and attendance at conferences from the following: Boehringer Ingelheim, Eli Lilly, Janssen, Lundbeck, Novo Nordisk, Novartis, Otsuka, Sanofi, Sunovion, Takeda, MSD. M.J.D. reports personal fees from Novo Nordisk, Sanofi-Aventis, Lilly, Merck Sharp & Dohme, Boehringer Ingelheim, AstraZeneca, Janssen, Servier, Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceuticals International Inc.; and, grants from Novo Nordisk, Sanofi-Aventis, Lilly, Boehringer Ingelheim, Janssen. K.K. has received fees for consultancy and speaker for Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Servier and Merck Sharp & Dohme. He has received grants in support of investigator and investigator-initiated trials from Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Pfizer, Boehringer Ingelheim and Merck Sharp & Dohme. K.K. has received funds for research, honoraria for speaking at meetings and has served on advisory boards for Lilly, Sanofi-Aventis, Merck Sharp & Dohme and Novo Nordisk. D.Sh. is expert advisor to the NICE Centre for guidelines; board member of the National Collaborating Centre for Mental Health (NCCMH); clinical advisor (paid consultancy basis) to National Clinical Audit of Psychosis (NCAP); views are personal and not those of NICE, NCCMH or NCAP. J.P. received personal fees for involvement in the study from a National Institute for Health Research (NIHR) grant. M.E.C. and Y.D. report grants from NIHR Health Technology Assessment, during the conduct of the study; and The Leicester Diabetes Centre, an organisation (employer) jointly hosted by an NHS Hospital Trust and the University of Leicester and who is holder (through the University of Leicester) of the copyright of the STEPWISE programme and of the DESMOND suite of programmes, training and intervention fidelity framework that were used in this study. S.R. has received honorarium from Lundbeck for lecturing. F.G. reports personal fees from Otsuka and Lundbeck, personal fees and non-financial support from Sunovion, outside the submitted work; and has a family member with professional links to Lilly and GSK, including shares. F.G. is in part funded by the National Institute for Health Research Collaboration for Leadership in Applied Health Research & Care Funding scheme, by the Maudsley Charity and by the Stanley Medical Research Institute and is supported by the by the Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London.

Using qualitative data to enhance our understanding of the reasons young people decline Structured Diabetes Education programmes.

AIM: To explore the reasons young people with type 1 diabetes decline Structured Diabetes Education from the perspectives of the young people themselves, their parents and diabetes educators. BACKGROUND: Structured Diabetes Education programmes that are evidence based and quality assured are a key component to empowering people with diabetes to self-manage effectively. However, research reveals that uptake of structured education programmes is disappointingly low. DESIGN: Qualitative cross-sectional study involving participants from Northern Ireland and England. METHODS: Twenty young people with type 1 diabetes (13-22 years) who had declined Structured Diabetes Education within the past 2 years, 17 parents of a young person with type 1 diabetes and 16 diabetes educators participated in semistructured interviews and focus groups. RESULTS: Three main themes emerged from across all three groups: timing, access and communication issues. In addition, a lack of understanding by the referrer was cited by some young people and their parents. Diabetes educators were sympathetic and understood many of the reasons why Structured Diabetes Education was declined. Solutions were proposed to overcome expressed barriers. CONCLUSIONS: Although the expressed reasons for declining might suggest that the young people simply did not prioritise education, this study adds a more nuanced scenario to the debate. The interviews revealed the tensions that exist between people's daily commitments and their need to self-manage their diabetes. The young people and their parents must be given a much stronger sense of the importance of Structured Diabetes Education and ways to accommodate attendance must be sought. Diabetes educators must be able to better promote the importance of Structured Diabetes Education. RELEVANCE TO CLINICAL PRACTICE: As optimal glycaemic control is so vital for long-term health, there is an urgent need to understand how to respond more fully to the needs of young people who have type 1 diabetes.

The development of a self-management intervention for stroke survivors - My Life After Stroke (MLAS).

PURPOSE: Long-term needs of stroke survivors (especially psychosocial needs and stroke prevention) are not adequately addressed. Self-management programmes exist but the optimal content and delivery approach is unclear. We aim to describe the process undertook to develop a structured self-management programme to address these unmet needs. MATERIALS AND METHODS: Based on the Medical Research Council framework for complex interventions, the development involved three phases: "Exploring the idea": Evidence synthesis and patient and public involvement (PPI) with stroke survivors, carers and healthcare professionals. "The iterative phase": Development and iterative refinement of the format, content, underpinning theories and philosophy of the self-management programme My Life After Stroke (MLAS), with PPI. MLAS consists of two individual appointments and four group sessions over nine weeks, delivered interactively by two trained facilitators. It aims to build independence, confidence and hope and focusses on stroke prevention, maximising physical potential, social support and managing emotional responses. MLAS is grounded in the narrative approach and social learning theory. "Ready for research": The refinement of a facilitator curriculum and participant resources to support programme delivery. RESULTS: Through a systematic process, we developed an evidence- and theory-based self-management programme for stroke survivors. CONCLUSIONS: MLAS warrants evaluation in a feasibility study.Implications for rehabilitationMy Life After Stroke(MLAS) has been developed using a systematic process, to address the unmet needs of stroke survivors.This systematic process, involved utilising evidence, theories, patient and public involvement, expertise and guidelines from other long-term conditions. This may further help the development of similar self-management programme within the field of stroke.MLAS warrants further evaluation within a feasibility study.

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.

BACKGROUND: The 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/DESIGN: The 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. DISCUSSION: The 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 REGISTRATION: ISRCTN: ISRCTN95696668.

Should glycated haemoglobin (HbA1c) be used to detect people with type 2 diabetes mellitus and impaired glucose regulation?

There is a need to simplify screening tests for type 2 diabetes mellitus (T2DM) so patients can be identified earlier and more efficiently. Glycated haemoglobin (HbA1c) has been recommended by some international organisations as a diagnostic tool for detecting T2DM and impaired glucose regulation (IGR, also termed prediabetes and includes impaired fasting glucose and/or impaired glucose tolerance). The HbA1c cut-point of ≥6.5% (48 mmol/mol) has been selected as diagnostic for T2DM, while the cut-points for IGR are debated by the different international organisations: an International Expert Committee has suggested using HbA1c 6.0-6.4% (42-46 mmol/mol); however, the American Diabetes Association has recommended using HbA1c 5.7-6.4% (39-46 mmol/mol). Some countries will adopt a new method of reporting HbA1c values in millimoles per mole (mmol/mol). Use of HbA1c has some logistical advantages over using an oral glucose tolerance test (OGTT). As patients do not need to fast, appointments do not need to be limited to the morning. The HbA1c result reflects longer term glycaemia and is less affected by recent physical/emotional stress. However, there is some debate as to whether HbA1c should replace fasting plasma glucose or the OGTT. As the two tests detect different people, some individuals with diabetes detected on OGTT will no longer be classified as having T2DM using HbA1c ≥6.5% criteria. Furthermore, some medical conditions can result in HbA1c assay measurements not reflecting glycaemic control over the last 2-3 months; these include haematological disorders, renal failure, and chronic excess alcohol consumption.

Declining structured diabetes education in those with type 2 diabetes: A plethora of individual and organisational reasons.

OBJECTIVE: to identify the expressed reasons adults with type 2 diabetes decline structured diabetes education (SDE). METHODS: cross sectional survey of 335 adults with type 2 diabetes who had declined SDE within the past two years, from across Northern Ireland and England. Standardised instruments comprising The Diabetes Attitude Scale, Diabetes Empowerment Scale (Short Form), and Diabetes Knowledge Test plus a questionnaire to elicit the reasons for declining SDE were used. RESULTS: Mean age 57.6 years (±21.1) 50.7% males, predominantly of White ethnicity (85.7%). They were most frequently invited to attend by a diabetes specialist nurse (36%), general practitioner (27%) or practice nurse (19%). Although a diversity of reasons for declining SDE were cited the most common were; 'The course was too long' (47.2%), 'I have other health problems' (41.2%) and they had other priorities (33.4%). Hierarchical cluster analysis revealed that expressed reasons for declining SDE were highly individualised. CONCLUSION: The wide range of reasons that impeded attendance suggests there is no simple solution that will improve attendance rates. PRACTICE IMPLICATIONS: In the same way that medical treatment for diabetes is becoming increasingly individualised, educational provision should be encouraged to move away from a one size fits all model.

Assessing the effectiveness of a goal-setting session as part of a structured group self-management education programme for people with type 2 diabetes.

OBJECTIVES: To measure the number of people who have identified a behaviour change goal and completed an action-plan to meet their goal on completion of a diabetes self-management education programme (DSME) and level of success in sustaining their action-plan. The DSME people attended was Diabetes Education and Self-Management for Ongoing and Newly Diagnosed (DESMOND). METHODS: Copies of action-plans were collected from participants. Postal questionnaires were sent to participants one week and three months following DESMOND to assess factors associated with setting and sustaining action-plans. RESULTS: 92% (253/275) of participants completed an action-plan. Reducing weight was the area most targeted. Physical activity was the most common goal. 68% (187/275) returned a three month questionnaire. 96% indicated they were still working on their action plan, with 87% reporting they were always/usually meeting their action-plan. 22% said they had discussed their goal with a health care professional (HCP) following DESMOND. CONCLUSIONS: Goal-setting as part of a DSME can lead to behaviour change. PRACTICE IMPLICATIONS: Goal-setting as part of a DSME enables participants to set and attain behaviour change goals. Informing HCPs of a person's action-plan following a DSME may further support a person undertaking behaviour change.

Reducing weight gain in people with schizophrenia, schizoaffective disorder, and first episode psychosis: describing the process of developing the STructured lifestyle Education for People With SchizophrEnia (STEPWISE) intervention.

BACKGROUND: Obesity is twice as common in people with schizophrenia as the general population and associated with significantly worsened psychiatric and physical health. Despite National Institute for Health and Care Excellence guidelines for the management of psychosis recommending that mental health services offer lifestyle programmes to people with schizophrenia to improve physical health, this is not currently occurring. The aim of the STEPWISE research programme was to develop a lifestyle intervention addressing obesity and preventing weight gain in people with schizophrenia, schizoaffective disorder, or first episode psychosis taking antipsychotic medication, through an approach and fundamental principles drawn from existing diabetes and diabetes prevention interventions. This paper describes the often under-reported process of developing such an intervention from first principles. METHODS: Following an extensive literature review, an iterative cycle of development with input from people with schizophrenia, mental healthcare professionals, facilitators, and other stakeholders, a new weight management intervention for the target group was developed. A set of four core weekly sessions was piloted in Sheffield, followed at 3-monthly intervals by three booster sessions and telephone support contact once every 2 weeks, to form an intervention lasting 12 months. Facilitators were provided with a 4-day training package to support delivery of the intervention. RESULTS: This paper reports the process of development, including challenges and how these were addressed. It describes how user input influenced the structure, topics, and approach of the intervention. The outcome of this process was a feasible and acceptable lifestyle intervention to support people with schizophrenia, schizoaffective disorder, or first episode psychosis to manage their weight. This pilot provided opportunities for refinement of the intervention and facilitator training prior to testing in a multi-centre randomised controlled trial. Key findings from the pilot were linked to accessibility, focus, uptake, and retention, which influenced session length, travel arrangements, refreshment, breaks, and supporting tools to incentivise participants. CONCLUSIONS: The STEPWISE intervention has been evaluated in a randomised controlled trial in 10 mental health trusts in England, and the results will be published in the British Journal of Psychiatry and the NIHR Journals Library. TRIAL REGISTRATION: ISRCTN19447796. Date registered: 20/03/2014.

Structured lifestyle education to support weight loss for people with schizophrenia, schizoaffective disorder and first episode psychosis: the STEPWISE RCT.

BACKGROUND: Obesity is twice as common in people with schizophrenia as in the general population. The National Institute for Health and Care Excellence guidance recommends that people with psychosis or schizophrenia, especially those taking antipsychotics, be offered a healthy eating and physical activity programme by their mental health care provider. There is insufficient evidence to inform how these lifestyle services should be commissioned. OBJECTIVES: To develop a lifestyle intervention for people with first episode psychosis or schizophrenia and to evaluate its clinical effectiveness, cost-effectiveness, delivery and acceptability. DESIGN: A two-arm, analyst-blind, parallel-group, randomised controlled trial, with a 1 : 1 allocation ratio, using web-based randomisation; a mixed-methods process evaluation, including qualitative case study methods and logic modelling; and a cost-utility analysis. SETTING: Ten community mental health trusts in England. PARTICIPANTS: People with first episode psychosis, schizophrenia or schizoaffective disorder. INTERVENTIONS: Intervention group: (1) four 2.5-hour group-based structured lifestyle self-management education sessions, 1 week apart; (2) multimodal fortnightly support contacts; (3) three 2.5-hour group booster sessions at 3-monthly intervals, post core sessions. Control group: usual care assessed through a longitudinal survey. All participants received standard written lifestyle information. MAIN OUTCOME MEASURES: The primary outcome was change in weight (kg) at 12 months post randomisation. The key secondary outcomes measured at 3 and 12 months included self-reported nutrition (measured with the Dietary Instrument for Nutrition Education questionnaire), objectively measured physical activity measured by accelerometry [GENEActiv (Activinsights, Kimbolton, UK)], biomedical measures, adverse events, patient-reported outcome measures and a health economic assessment. RESULTS: The trial recruited 414 participants (intervention arm: 208 participants; usual care: 206 participants) between 10 March 2015 and 31 March 2016. A total of 341 participants (81.6%) completed the trial. A total of 412 participants were analysed. After 12 months, weight change did not differ between the groups (mean difference 0.0 kg, 95% confidence interval -1.59 to 1.67 kg; p = 0.964); physical activity, dietary intake and biochemical measures were unchanged. Glycated haemoglobin, fasting glucose and lipid profile were unchanged by the intervention. Quality of life, psychiatric symptoms and illness perception did not change during the trial. There were three deaths, but none was related to the intervention. Most adverse events were expected and related to the psychiatric illness. The process evaluation showed that the intervention was acceptable, with participants valuing the opportunity to interact with others facing similar challenges. Session feedback indicated that 87.2% of participants agreed that the sessions had met their needs. Some indicated the desire for more ongoing support. Professionals felt that the intervention was under-resourced and questioned the long-term sustainability within current NHS settings. Professionals would have preferred greater access to participants' behaviour data to tailor the intervention better. The incremental cost-effectiveness ratio from the health-care perspective is £246,921 per quality-adjusted life-year (QALY) gained and the incremental cost-effectiveness ratio from the societal perspective is £367,543 per QALY gained. CONCLUSIONS: Despite the challenges of undertaking clinical research in this population, the trial successfully recruited and retained participants, indicating a high level of interest in weight management interventions; however, the STEPWISE intervention was neither clinically effective nor cost-effective. Further research will be required to define how overweight and obesity in people with schizophrenia should be managed. The trial results suggest that lifestyle programmes for people with schizophrenia may need greater resourcing than for other populations, and interventions that have been shown to be effective in other populations, such as people with diabetes mellitus, are not necessarily effective in people with schizophrenia. TRIAL REGISTRATION: Current Controlled Trials ISRCTN19447796. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 65. See the NIHR Journals Library website for further project information.

Is diabetes self-management education still the Cinderella of diabetes care?

This paper reflects on the status of diabetes self-management education (DSME) as a branch of diabetology in Europe and discusses some opportunities for better supporting DSME delivery. DSME (also commonly known as Therapeutic Patient Education) has been evolving as a therapy for diabetes for decades. As a continent, Europe is fortunate to have nurtured many pioneers in DSME, and currently has many experts in the field progressing the knowledge base and striving to improve access to DSME for people with diabetes. While there is a wide variety of DSME programmes being delivered throughout Europe, for most people diabetes education is not truly embedded in routine clinical care, being seen as more of an optional add-on to conventional therapies. In comparison to drugs and devices, DSME lacks investment, and funding for DSME research lags far behind other therapies. The rigour with which forms of DSME are developed and evaluated varies, and there is a lack of European quality standards. To try to address some of these deficiencies, greater pan-European collaboration and leadership is required.

Diabetes Education and Self-Management for Ongoing and Newly Diagnosed (DESMOND): process modelling of pilot study.

OBJECTIVE: To determine the effects of a structured education program on illness beliefs, quality of life and physical activity in people newly diagnosed with Type 2 diabetes. METHODS: Individuals attending a diabetes education and self-management for ongoing and newly diagnosed (DESMOND) program in 12 Primary Care Trusts completed questionnaire booklets assessing illness beliefs and quality of life at baseline and 3-month follow-up, metabolic control being assessed through assay of HbA1c. RESULTS: Two hundred and thirty-six individuals attended the structured self-management education sessions, with 97% and 64% completing baseline and 3-month follow-up questionnaires. At 3 months, individuals were more likely to: understand their diabetes; agree it is a chronic illness; agree it is a serious condition, and that they can affect its course. Individuals achieving a greater reduction in HbA1c over the first 3 months were more likely to agree they could control their diabetes at 3 months (r=0.24; p=0.05), and less likely to agree that diabetes would have a major impact on their day to day life (r=0.35; p=0.006). CONCLUSION: Pilot data indicate the DESMOND program for individuals newly diagnosed with Type 2 diabetes changes key illness beliefs and that these changes predict quality of life and metabolic control at 3-month follow-up. PRACTICE IMPLICATIONS: Newly diagnosed individuals are open to attending self-management programs and, if the program is theoretically driven, can successfully engage with the true, serious nature of diabetes.

STEPWISE - STructured lifestyle Education for People WIth SchizophrEnia: a study protocol for a randomised controlled trial.

BACKGROUND: People with schizophrenia are two to three times more likely to be overweight than the general population. The UK National Institute of Health and Care Excellence (NICE) recommends an annual physical health review with signposting to, or provision of, a lifestyle programme to address weight concerns and obesity. The purpose of this randomised controlled trial is to assess whether a group-based structured education programme can help people with schizophrenia to lose weight. METHODS: Design: a randomised controlled trial of a group-based structured education programme. SETTING: 10 UK community mental health trusts. PARTICIPANTS: 396 adults with schizophrenia, schizoaffective, or first-episode psychosis who are prescribed antipsychotic medication will be recruited. Participants will be overweight, obese or be concerned about their weight. INTERVENTION: participants will be randomised to either the intervention or treatment as usual (TAU). The intervention arm will receive TAU plus four 2.5-h weekly sessions of theory-based lifestyle structured group education, with maintenance contact every 2 weeks and 'booster' sessions every 3 months. All participants will receive standardised written information about healthy eating, physical activity, alcohol and smoking. OUTCOMES: the primary outcome is weight (kg) change at 1 year post randomisation. Secondary outcomes, which will be assessed at 3 and 12 months, include: the proportion of participants who maintained or reduced their weight; waist circumference; body mass index; objectively measured physical activity (wrist accelerometer); self-reported diet; blood pressure; fasting plasma glucose, lipid profile and HbA1c (baseline and 1 year only); health-related quality of life (EQ-5D-5L and RAND SF-36); (adapted) brief illness perception questionnaire; the Brief Psychiatric Rating Scale; the Client Service Receipt Inventory; medication use; smoking status; adverse events; depression symptoms (Patient Health Questionnaire-9); use of weight-loss programmes; and session feedback (intervention only). Outcome assessors will be blind to trial group allocation. Qualitative interviews with a subsample of facilitators and invention-arm participants will provide data on intervention feasibility and acceptability. Assessment of intervention fidelity will also be performed. DISCUSSION: The STEPWISE trial will provide evidence for the clinical and cost-effectiveness of a tailored intervention, which, if successful, could be implemented rapidly in the NHS. TRIAL REGISTRATION: ISRCTN19447796 , registered on 20 March 2014.

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.

BACKGROUND: The 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/DESIGN: This 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. DISCUSSION: The 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 REGISTRATION: Registered with International Standard Randomised Controlled Trial (identifier: ISRCTN93185560 ) on 10 November 2014.

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.

Diabetes in people with intellectual disabilities: A systematic review of the literature.

OBJECTIVE: To present an analysis of the evidence related to the prevalence of diabetes in people with intellectual disabilities (ID), their experiences of their condition and treatment and those of their carers. MATERIALS AND METHODS: A systematic literature review was conducted. A total of 22 studies exploring diabetes prevalence and 5 exploring views and experiences of diabetes in people with ID were identified and included. A narrative synthesis approach was utilised to amalgamate data extracted from the included studies regarding some 49,046 participants with ID and diabetes and 31 care professionals and family members across Europe, North America, New Zealand, Australia, China and Hong Kong. RESULTS: Prevalence rates of diabetes in people with ID were highly varied, ranging from 0.4% to 25%. 7 studies reported significantly higher rates of diabetes in people with ID than the general population. People with ID reported a basic understanding of diabetes and wanted to know more. Carers reported that they lack diabetes knowledge and do not routinely encourage diabetes self-management skills. Several studies neglected to report vital demographic information such as participants' level of ID (13 studies) and diabetes type (16 studies) and the quality of included prevalence studies was variable. CONCLUSIONS: Further research in this field is required, notably prevalence studies which control for participant demographics and personal situations to obtain more accurate diabetes prevalence rates in this population group. People with ID and diabetes should be encouraged to participate in future research and we recommend exploring the feasibility of adapting current mainstream diabetes management programmes for these individuals.

Developing and piloting a structured, stepped approach to patient education.

The DESMOND initiative aims to provide patients with Type 2 diabetes with ongoing education about their condition from the point of diagnosis. The programme is in the process of developing a structured education curriculum that, combined with clinical management, will offer an integrated care pathway to patients.

Effectiveness of a diabetes education and self management programme (DESMOND) for people with newly diagnosed type 2 diabetes mellitus: three year follow-up of a cluster randomised controlled trial in primary care.

OBJECTIVE: To measure whether the benefits of a single education and self management structured programme for people with newly diagnosed type 2 diabetes mellitus are sustained at three years. DESIGN: Three year follow-up of a multicentre cluster randomised controlled trial in primary care, with randomisation at practice level. SETTING: 207 general practices in 13 primary care sites in the United Kingdom. PARTICIPANTS: 731 of the 824 participants included in the original trial were eligible for follow-up. Biomedical data were collected on 604 (82.6%) and questionnaire data on 513 (70.1%) participants. INTERVENTION: A structured group education programme for six hours delivered in the community by two trained healthcare professional educators compared with usual care. MAIN OUTCOME MEASURES: The primary outcome was glycated haemoglobin (HbA(1c)) levels. The secondary outcomes were blood pressure, weight, blood lipid levels, smoking status, physical activity, quality of life, beliefs about illness, depression, emotional impact of diabetes, and drug use at three years. RESULTS: HbA(1c) levels at three years had decreased in both groups. After adjusting for baseline and cluster the difference was not significant (difference -0.02, 95% confidence interval -0.22 to 0.17). The groups did not differ for the other biomedical and lifestyle outcomes and drug use. The significant benefits in the intervention group across four out of five health beliefs seen at 12 months were sustained at three years (P<0.01). Depression scores and quality of life did not differ at three years. CONCLUSION: A single programme for people with newly diagnosed type 2 diabetes mellitus showed no difference in biomedical or lifestyle outcomes at three years although there were sustained improvements in some illness beliefs. TRIAL REGISTRATION: Current Controlled Trials ISRCTN17844016.