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The aims of this study were to assess cognitions relating to hypoglycaemia in adults with type 1 diabetes and impaired awareness of hypoglycaemia before and after the multimodal HypoCOMPaSS intervention, and to determine cognitive predictors of incomplete response (one or more severe hypoglycaemic episodes over 24 months).This analysis included 91 adults with type 1 diabetes and impaired awareness of hypoglycaemia who completed the Attitudes to Awareness of Hypoglycaemia (A2A) questionnaire before, 24 weeks and 24 months after the intervention, which comprised a short psycho-educational programme with optimisation of insulin therapy and glucose monitoring.The age and diabetes duration of the participants were 48±12 and 29±12 years, respectively (mean±SD). At baseline, 91% reported one or more severe hypoglycaemic episodes over the preceding 12 months; this decreased to20% at 24 weeks and after 24 months (p=0.001). The attitudinal barrier 'hyperglycaemia avoidance prioritised' (ηParticipation in the HypoCOMPaSS RCT was associated with improvements in hypoglycaemia-associated cognitions, with 'hyperglycaemia avoidance prioritised' most prevalent. Incomplete prevention of subsequent severe hypoglycaemia episodes was associated with persistence of the cognition 'asymptomatic hypoglycaemia normalised'. Understanding and addressing cognitive barriers to hypoglycaemia avoidance is important in individuals prone to severe hypoglycaemia episodes.www.isrctn.org : ISRCTN52164803 and https://eudract.ema.europa.eu : EudraCT2009-015396-27.

Impaired awareness of hypoglycaemia (IAH) is a major risk for severe hypoglycaemia in insulin treatment of type 1 diabetes (T1D). To explore the hypothesis that unhelpful health beliefs create barriers to regaining awareness, we conducted a multi-centre, randomised, parallel, two-arm trial (ClinicalTrials.gov NCT02940873) in adults with T1D and treatment-resistant IAH and severe hypoglycaemia, with blinded analysis of 12-month recall of severe hypoglycaemia at 12 and/or 24 months the primary outcome. Secondary outcomes included cognitive and emotional measures. Adults with T1D, IAH and severe hypoglycaemia despite structured education in insulin adjustment, +/− diabetes technologies, were randomised to the “Hypoglycaemia Awareness Restoration Programme despite optimised self-care” (HARPdoc, n = 49), a psychoeducation programme uniquely focussing on changing cognitive barriers to avoiding hypoglycaemia, or the evidence-based “Blood Glucose Awareness Training” (BGAT, n = 50), both delivered over six weeks. Median [IQR] severe hypoglycaemia at baseline was 5[2–12] per patient/year, 1[0–5] at 12 months and 0[0–2] at 24 months, with no superiority for HARPdoc (HARPdoc vs BGAT incident rate ratios [95% CI] 1.25[0.51, 3.09], p = 0.62 and 1.26[0.48, 3.35], p = 0.64 respectively), nor for changes in hypoglycaemia awareness scores or fear. Compared to BGAT, HARPdoc significantly reduced endorsement of unhelpful cognitions (Estimated Mean Difference for Attitudes to Awareness scores at 24 months, −2.07 [−3.37,−0.560], p = 0.01) and reduced scores for diabetes distress (−6.70[−12.50,−0.89], p = 0.02); depression (−1.86[−3.30, −0.43], p = 0.01) and anxiety (−1.89[−3.32, −0.47], p = 0.01). Despite positive impact on cognitive barriers around hypoglycaemia avoidance and on diabetes-related and general emotional distress scores, HARPdoc was not more effective than BGAT at reducing severe hypoglycaemia.

OBJECTIVE The Hypoglycemia Fear Survey-II (HFS-II) is a well-validated measure of fear of hypoglycemia in people with type 1 diabetes. The aim of this study was to explore the relationships between hypoglycemia worries, behaviors, and cognitive barriers to hypoglycemia avoidance and hypoglycemia awareness status, severe hypoglycemia, and HbA1c. RESEARCH DESIGN AND METHODS Participants with type 1 diabetes (n = 178), with the study population enriched for people at risk for severe hypoglycemia (49%), completed questionnaires for assessing hypoglycemia fear (HFS-II), hyperglycemia avoidance (Hyperglycemia Avoidance Scale [HAS]), diabetes distress (Problem Areas In Diabetes [PAID]), and cognitive barriers to hypoglycemia avoidance (Attitudes to Awareness of Hypoglycemia [A2A]). Exploratory factor analysis was applied to the HFS-II. We sought to establish clusters based on HFS-II, A2A, Gold, HAS, and PAID using k-means clustering. RESULTS Four HFS-II factors were identified: Sought Safety, Restricted Activity, Ran High, and Worry. While Sought Safety, Restricted Activity, and Worry increased with progressively impaired awareness and recurrent severe hypoglycemia, Ran High did not. With cluster analysis we outlined four clusters: two clusters with preserved hypoglycemia awareness were differentiated by low fear/low cognitive barriers to hypoglycemia avoidance (cluster 1) versus high fear and distress and increased Ran High behaviors (cluster 2). Two clusters with impaired hypoglycemia awareness were differentiated by low fear/high cognitive barriers (cluster 3) as well as high fear/low cognitive barriers (cluster 4). CONCLUSIONS This is the first study to define clusters of hypoglycemia experience by worry, behaviors, and cognitive barriers to hypoglycemia avoidance. The resulting subtypes may be important in understanding and treating problematic hypoglycemia.

OBJECTIVE Impaired awareness of hypoglycemia (IAH) and recurrent severe hypoglycemia (RSH) remain problematic for people with type 1 diabetes (T1D), despite major therapeutic advances. We explored beliefs around hypo- and hyperglycemia in adults with T1D with, and without, IAH and RSH. RESEARCH DESIGN AND METHODS A cross-sectional U.S. multicenter survey included Attitudes to Awareness of Hypoglycemia (A2A; a 19-item questionnaire concerning beliefs about hypoglycemia), the Gold score (single item: awareness of hypoglycemia), and a question about severe hypoglycemia over the preceding year. The survey was emailed to 6,200 adult participants of the annual T1D Exchange clinic registry data collection. A2A data were subjected to principal component analysis with varimax rotation. RESULTS Among 1,978 respondents (response rate 32%), 61.7% were women, mean ± SD age was 39.6 ± 16.3 years, and T1D duration was 23.1 ± 13.8 years. Thirty-seven percent reported IAH, 16% RSH, and 9% both. A2A items segregated into three factors, differently distributed by hypoglycemia experience. Respondents with IAH or RSH expressed appropriate concern about hypoglycemia, but those with IAH were more likely to prioritize hyperglycemia concerns than those with intact awareness (P = 0.002). Those with RSH showed greater normalization of asymptomatic hypoglycemia than those without (P = 0.019) and trended toward prioritizing hyperglycemia concerns (P = 0.097), driven by those with both IAH and RSH. CONCLUSIONS Adults with T1D with IAH and RSH report specific cognitions about hypoglycemia and hyperglycemia, which may act as barriers to hypoglycemia avoidance and recovery of awareness. These may be modifiable and present a target for enhancing engagement of vulnerable people with strategies to avoid future hypoglycemia.

Background People with type 1 diabetes who attend structured education training in self-management using flexible intensive therapy achieve improved blood glucose control and experience fewer episodes of severe hypoglycaemia. However, many struggle to sustain these improvements over time. To inform the design of more effective follow-up support we undertook a review of qualitative studies which have identified factors that influence and inform participants’ self-management behaviours after attending structured education and their need for support to sustain improvements in glycaemic control. Methods We undertook a meta-ethnography of relevant qualitative studies, identified using systematic search methods. Studies were included which focused on participants’ experiences of self-managing type 1 diabetes after attending structured education which incorporated training in flexible intensive insulin therapy. A line of argument approach was used to synthesise the findings. Results The search identified 18 papers from six studies. The studies included were judged to be of high methodological quality. The line of argument synthesis developed the Follow-Up Support for Effective type 1 Diabetes self-management (FUSED) model. This model outlines the challenges participants encounter in maintaining diabetes self-management practices after attending structured education, and describes how participants try to address these barriers by adapting, simplifying or personalising the self-management approaches they have learned. To help participants maintain the skills taught during courses, the FUSED model presents ten recommendations abstracted from the included papers to provide a logic model for a programme of individualised and responsive follow-up support. Conclusions This meta-ethnography highlights how providing skills training using structured education to people with type 1 diabetes does not necessarily result in participants adopting and sustaining recommended changes in behaviour. To help people sustain diabetes self-management skills after attending structured education, it is recommended that support be provided over the longer-term by appropriately trained healthcare professionals which is responsive to individuals’ needs. Although developed to inform support for people with type 1 diabetes, the FUSED model provides a framework that could also be applied to support individuals with other long term conditions which require complex self-management skills to be learned and sustained over time. Trial registration PROSPERO registration: CRD42017067961. Electronic supplementary material The online version of this article (10.1186/s12913-018-3655-z) contains supplementary material, which is available to authorized users.

Aims Self‐management programmes for type 1 diabetes, such as the UK’s Dose Adjustment for Normal Eating (DAFNE), improve short‐term clinical outcomes but difficulties maintaining behavioural changes attenuate long‐term impact. This study used the Behaviour Change Wheel (BCW) framework to revise the DAFNE intervention to support sustained behaviour change. Methods A four‐step method was based on the BCW intervention development approach: 1) Identifying self‐management behaviours and barriers/enablers to maintaining them via stakeholder consultation and evidence synthesis, and mapping barriers/enablers to the Capability, Opportunity, Motivation‐Behaviour (COM‐B) model. 2) Specifying behaviour change techniques (BCTs) in the existing DAFNE intervention using the Behaviour Change Techniques Taxonomy (BCTTv1). 3) Identifying additional BCTs to target the barriers/enablers using the BCW and BCTTv1. 4) Parallel stakeholder consultation to generate recommendations for intervention revision. Revised materials were co‐designed by stakeholders (diabetologists, psychologists, specialist nurses and dietitians). Results Thirty‐four barriers and five enablers to sustaining self‐management post‐DAFNE, were identified. The existing DAFNE intervention contained 24 BCTs, which partially addressed the enablers. Twenty‐seven BCTs were added, including ‘Habit formation’, ‘Credible source’ and ‘Conserving mental resources’. Fifteen stakeholder‐agreed recommendations for content and delivery were incorporated into the final DAFNEplus intervention, comprising three co‐designed components: (1) face‐to‐face group learning course, (2) individual structured follow‐up sessions, (3) technological support, including blood glucose data management. Conclusions This method provided a systematic approach to specifying and revising a behaviour change intervention incorporating stakeholder input. The revised DAFNEplus intervention aims to support the maintenance of behavioural changes by targeting barriers and enablers to sustaining self‐management behaviours.

IntroductionThe successful treatment of type 1 diabetes (T1D) requires those affected to employ insulin therapy to maintain their blood glucose levels as close to normal to avoid complications in the long-term. The Dose Adjustment For Normal Eating (DAFNE) intervention is a group education course designed to help adults with T1D develop and sustain the complex self-management skills needed to adjust insulin in everyday life. It leads to improved glucose levels in the short term (manifest by falls in glycated haemoglobin, HbA1c), reduced rates of hypoglycaemia and sustained improvements in quality of life but overall glucose levels remain well above national targets. The DAFNEplus intervention is a development of DAFNE designed to incorporate behavioural change techniques, technology and longer-term structured support from healthcare professionals (HCPs).Methods and analysisA pragmatic cluster randomised controlled trial in adults with T1D, delivered in diabetes centres in National Health Service secondary care hospitals in the UK. Centres will be randomised on a 1:1 basis to standard DAFNE or DAFNEplus. Primary clinical outcome is the change in HbA1c and the primary endpoint is HbA1c at 12 months, in those entering the trial with HbA1c >7.5% (58 mmol/mol), and HbA1c at 6 months is the secondary endpoint. Sample size is 662 participants (approximately 47 per centre); 92% power to detect a 0.5% difference in the primary outcome of HbA1c between treatment groups. The trial also measures rates of hypoglycaemia, psychological outcomes, an economic evaluation and process evaluation.Ethics and disseminationEthics approval was granted by South West-Exeter Research Ethics Committee (REC ref: 18/SW/0100) on 14 May 2018. The results of the trial will be published in a National Institute for Health Research monograph and relevant high-impact journals.Trial registration numberISRCTN42908016.

Aims\ud \ud Sustained engagement in type 1 diabetes self‐management behaviours is a critical element in achieving improvements in glycated haemoglobin (HbA1c) and minimising risk of complications. Evaluations of self‐management programmes, such as Dose Adjustment for Normal Eating (DAFNE), typically find that initial improvements are rarely sustained beyond 12 months. This study identified behaviours involved in sustained type 1 diabetes self‐management, their influences and relationships to each other.\ud \ud \ud Methods\ud \ud A mixed‐methods study was conducted following the first two steps of the Behaviour Change Wheel framework. First, an expert stakeholder consultation identified behaviours involved in self‐management of type 1 diabetes. Second, three evidence sources (systematic review, healthcare provider‐generated ‘red flags’ and participant‐generated ‘frequently asked questions’) were analysed to identify and synthesise modifiable barriers and enablers to sustained self‐management. These were characterised according to the Capability‐Opportunity‐Motivation‐Behaviour (COM‐B) model.\ud \ud \ud Results\ud \ud 150 distinct behaviours were identified and organised into three self‐regulatory behavioural cycles, reflecting different temporal and situational aspects of diabetes self‐management: Routine (e.g. checking blood glucose), Reactive (e.g. treating hypoglycaemia) and Reflective (e.g. reviewing blood glucose data to identify patterns). Thirty‐four barriers and five enablers were identified: 10 relating to Capability, 20 to Opportunity and nine to Motivation.\ud \ud \ud Conclusions\ud \ud Multiple behaviours within three self‐management cycles are involved in sustained type 1 diabetes self‐management. There are a wide range of barriers and enablers that should be addressed to support self‐management behaviours and improve clinical outcomes. The present study provides an evidence base for refining and developing type 1 diabetes self‐management programmes.

Background Motivational interviewing (MI) enhanced with behaviour change techniques (BCTs) and deployed by health trainers targeting multiple risk factors for cardiovascular disease (CVD) may be more effective than interventions targeting a single risk factor. Objectives The clinical effectiveness and cost-effectiveness of an enhanced lifestyle motivational interviewing intervention for patients at high risk of CVD in group settings versus individual settings and usual care (UC) in reducing weight and increasing physical activity (PA) were tested. Design This was a three-arm, single-blind, parallel randomised controlled trial. Setting A total of 135 general practices across all 12 South London Clinical Commissioning Groups were recruited. Participants A total of 1742 participants aged 40–74 years with a ≥ 20.0% risk of a CVD event in the following 10 years were randomised. Interventions The intervention was designed to integrate MI and cognitive–behavioural therapy (CBT), delivered by trained healthy lifestyle facilitators in 10 sessions over 1 year, in group or individual format. The control group received UC. Randomisation Simple randomisation was used with computer-generated randomisation blocks. In each block, 10 participants were randomised to the group, individual or UC arm in a 4 : 3 : 3 ratio. Researchers were blind to the allocation. Main outcome measures The primary outcomes are change in weight (kg) from baseline and change in PA (average number of steps per day over 1 week) from baseline at the 24-month follow-up, with an interim follow-up at 12 months. An economic evaluation estimates the relative cost-effectiveness of each intervention. Secondary outcomes include changes in low-density lipoprotein cholesterol and CVD risk score. Results The mean age of participants was 69.75 years (standard deviation 4.11 years), 85.5% were male and 89.4% were white. At the 24-month follow-up, the group and individual intervention arms were not more effective than UC in increasing PA [mean 70.05 steps, 95% confidence interval (CI) –288 to 147.9 steps, and mean 7.24 steps, 95% CI –224.01 to 238.5 steps, respectively] or in reducing weight (mean –0.03 kg, 95% CI –0.49 to 0.44 kg, and mean –0.42 kg, 95% CI –0.93 to 0.09 kg, respectively). At the 12-month follow-up, the group and individual intervention arms were not more effective than UC in increasing PA (mean 131.1 steps, 95% CI –85.28 to 347.48 steps, and mean 210.22 steps, 95% CI –19.46 to 439.91 steps, respectively), but there were reductions in weight for the group and individual intervention arms compared with UC (mean –0.52 kg, 95% CI –0.90 to –0.13 kg, and mean –0.55 kg, 95% CI –0.95 to –0.14 kg, respectively). The group intervention arm was not more effective than the individual intervention arm in improving outcomes at either follow-up point. The group and individual interventions were not cost-effective. Conclusions Enhanced MI, in group or individual formats, targeted at members of the general population with high CVD risk is not effective in reducing weight or increasing PA compared with UC. Future work should focus on ensuring objective evidence of high competency in BCTs, identifying those with modifiable factors for CVD risk and improving engagement of patients and primary care. Trial registration Current Controlled Trials ISRCTN84864870. 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. 23, No. 69. See the NIHR Journals Library website for further project information. This research was part-funded by the NIHR Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King’s College London.

Background Competencies in psychological techniques delivered by primary care nurses to support diabetes self-management were compared between the intervention and control arms of a cluster randomised controlled trial as part of a process evaluation. The trial was pragmatic and designed to assess effectiveness. This article addresses the question of whether the care that was delivered in the intervention and control trial arms represented high fidelity treatment and attention control, respectively. Methods Twenty-three primary care nurses were either trained in motivational interviewing (MI) and cognitive behavioural therapy (CBT) skills or delivered attention control. Nurses’ skills in these treatments were evaluated soon after training (treatment arm) and treatment fidelity was assessed after treatment delivery for sessions midway through regimen (both arms) using the Motivational Interviewing Treatment Integrity (MITI) domains and Behaviour Change Counselling Index (BECCI) based on consultations with 151 participants (45% of those who entered the study). The MITI Global Spirit subscale measured demonstration of MI principles: evocation, collaboration, autonomy/support. Results After training, median MITI MI-Adherence was 86.2% (IQR 76.9–100%) and mean MITI Empathy was 4.09 (SD 1.04). During delivery of treatment, in the intervention arm mean MITI Spirit was 4.03 (SD 1.05), mean Empathy was 4.23 (SD 0.89), and median Percentage Complex Reflections was 53.8% (IQR 40.0–71.4%). In the attention control arm mean Empathy was 3.40 (SD 0.98) and median Percentage Complex Reflections was 55.6% (IQR 41.9–71.4%). Conclusions After MI and CBT skills training, detailed assessment showed that nurses had basic competencies in some psychological techniques. There appeared to be some delivery of elements of psychological treatment by nurses in the control arm. This model of training and delivery of MI and CBT skills integrated into routine nursing care to support diabetes self-management in primary care was not associated with high competency levels in all skills. Trial registration ISRCTN75776892; date registered: 19/05/2010.

Objective Severe hypoglycemia complicates insulin therapy for type 1 diabetes, with impaired awareness of hypoglycemia (IAH) being a major risk factor. We explored associations between the personality traits, alexithymia and perfectionism, and cognitive barriers to hypoglycemia avoidance described in IAH, and evaluated their prevalence in people with and without IAH. Methods Cross-sectional exploratory study. Ninety adults with type 1 diabetes, 54 hypoglycemia aware and 36 with IAH, completed validated questionnaires exploring alexithymia (Total Alexithymia Scale [TAS-20]) and perfectionism (Frost Multidimensional Perfectionism Scale [FMPS]); and cognitive barriers related to hypoglycemia avoidance (Attitudes to Awareness Questionnaire [A2A]. Results Alexithymia and perfectionism scores correlated positively with cognitive barriers associated with IAH. Specifically, alexthymia scores correlated with the ‘Hyperglycaemia Avoidance Prioritised’ factor (r = 0.265; p = .02, n = 77) and the ‘Asymptomatic Hypoglycemia Normalised’ factor (r = 0.252–0.255; p = .03, n = 77). Perfectionism scores correlated with the ‘Hyperglycaemia Avoidance Prioritised’ factor (r = 0.525; p, Highlights • Impaired awareness of hypoglycemia is a major problem in type 1 diabetes. • There is evidence for cognitive barriers to hypoglycemia avoidance in this condition. • Alexithymia and perfectionism may be associated with these cognitive barriers. • Identifying those with predispositions may help target psychological intervention.

IntroductionSevere hypoglycaemia (SH), when blood glucose falls too low to support brain function, is the most feared acute complication of insulin therapy for type 1 diabetes mellitus (T1DM). 10% of people with T1DM contribute nearly 70% of all episodes, with impaired awareness of hypoglycaemia (IAH) a major risk factor. People with IAH may be refractory to conventional approaches to reduce SH, with evidence for cognitive barriers to hypoglycaemia avoidance. This paper describes the protocol for the Hypoglycaemia Awareness Restoration Programme for People with Type 1 Diabetes and Problematic Hypoglycaemia Persisting Despite Optimised Self-care (HARPdoc) study, a trial to assess the impact on hypoglycaemia experience of a novel intervention that addresses cognitive barriers to hypoglycaemia avoidance, compared with an existing control intervention, recommended by the National Institute of Health and Care Excellence.Methods and analysisA randomised parallel two-arm trial of two group therapies: HARPdoc versus Blood Glucose Awareness Training, among 96 adults with T1DM and problematic hypoglycaemia, despite attendance at education with or without technology use, in four centres providing specialist T1DM services. The primary outcome will be the SH rate at 12 and/or 24 months after randomisation to either course. Secondary outcomes include rates of SH requiring parenteral therapy, involving unconsciousness or needing emergency services; hypoglycaemia awareness status, overall diabetes control and quality of life measures. An implementation study to evaluate how the interventions are delivered and how implementation impacts on clinical effectiveness is planned as a parallel study, with its own protocol.Ethics and disseminationThe protocol was approved by the London Dulwich Research Ethics Committee, the Health Research Authority, National Health Service R&D and the Institutional Review Board of the Joslin Diabetes Center in the USA. Study findings will be disseminated to study participants and through peer-reviewed publications and conference presentations, including user groups.Trial registration numberNCY02940873; Pre-results.

Background The increasing prevalence of type 2 diabetes and suboptimal glycaemic control in Kuwait requires novel, wide-reaching, low-cost interventions to motivate and mobilise individuals towards more effective self-management. More than 2 million people in Kuwait own mobile phones. We will test whether automated personalised health text messages based on principles of motivational interviewing and are responsive to biodata delivered remotely is potentially effective in improving glycaemic control compared to usual care. Methods This is a two-arm parallel single-blind randomised controlled trial of 572 individuals with type 2 diabetes in Kuwait. We will develop a culturally appropriate database of text messages supporting positive lifestyle changes in type 2 diabetes. A computer programme will deliver over 400 text messages over a 12-month period using algorithms which provide participants with information on diet and physical activity as well as personalised messages regarding motivators to change behaviours. Individuals aged 18–75 years with established type 2 diabetes who are fluent in Arabic or English and officially resident in Kuwait will be identified via screening of hospital diabetes clinic and primary care practices and invited to participate. A sample of 572 participants will be randomised to usual care or usual care plus the DATES text message intervention. Randomisation will be conducted by an independent Clinical Trials Unit and researchers collecting baseline and outcome data will be blinded to treatment allocation. The primary outcome is change in HbA1c and weight at 12 months in both study arms. Secondary outcomes will include changes in physical activity, fasting lipids and quality of life in both study arms. Discussion The potential of mobile phones in improving diabetes self-care in settings with a high prevalence of diabetes and widespread mobile phone usage has face validity. Mobile phones and text messaging are an understudied virtual communication media which can deliver discrete focused psychological support to motivate and enable diabetes self-care changes. Trial registration ISRCTN10342151. 11/03/2015. Electronic supplementary material The online version of this article (10.1186/s12889-018-6136-8) contains supplementary material, which is available to authorized users.

Background Randomised controlled trials (RCTs) of complex interventions often begin with a pilot phase to test the proposed methods and refine the intervention before it is trialled. Although the Medical Research Council (MRC) recommends regular communication between the practitioners delivering the intervention and the researchers evaluating it during the pilot phase, there is a lack of practical guidance about how to undertake this aspect of pre-trial work. This paper describes a novel structured process for collaborative working, which we developed to iteratively refine a complex intervention prior to an RCT. We also describe an in-built qualitative study to learn lessons about how this approach could be used by future study teams. Methods This work forms part of a broader research programme to develop and trial a complex intervention for people with type 1 diabetes, called DAFNEplus. The intervention is being piloted in three National Health Service (NHS) diabetes centres in two waves, with refinements being incrementally implemented between each wave in response to real-time, collective learning (combining practitioner experience, process evaluation data and patient and public involvement via an advisory group). A structured ‘Collaborative Working Group’ (CWG) process, comprising monthly teleconferences and four strategically timed face-to-face meetings, is being used to identify and respond systematically to emerging implementation challenges and research findings. The group involves 25 members of the study team, including the multi-disciplinary practitioners delivering the intervention, the research teams conducting the process evaluation, the study manager and Chief Investigator. An in-built qualitative study comprising documentary analysis of meeting materials, discourse analysis of meeting transcripts, reflexive note taking, and thematic analysis of focus groups and interviews with CWG members is being undertaken to explore how the CWG works and how its processes and procedures might be improved. Discussion The CWG process offers a potential model for collaborative working in future pre-trial pilot phases and intervention development studies that operationalises MRC guidance to progressively develop a complex intervention and foster shared ownership through genuine collaboration. The findings from the qualitative study will provide insight into how to best support collaborative working to achieve optimal intervention design.

BackgroundSuboptimal glycaemic control in type 2 diabetes (T2D) is common and associated with psychological barriers.AimTo investigate whether it was possible to train practice nurses in six psychological skills (Diabetes-6 [D6]) based on motivational interviewing (MI) and basic cognitive behaviour therapy (CBT), and whether integrating these with diabetes care was associated with improved glycaemic control over 18 months compared with standard care.Design and settingTwo-arm, single-blind, parallel cluster randomised controlled trial in primary care.MethodAdult participants (n = 334) with T2D and persistent HbA1c ≥69.4 mmol/mol were randomised to receive 12 sessions of either the D6 intervention or standard care over 12 months. Practice nurses were trained in the six psychological skills and their competencies were measured by standardised rating scales. Primary outcome was a change in HbA1c level at 18 months from randomisation. Secondary outcomes were changes in systolic and diastolic blood pressure, body mass index, waist circumference, depressive symptoms, harmful alcohol intake, diabetes-specific distress, and cost-effectiveness.ResultsUsing intention-to-treat analysis, there was no significant difference between D6 intervention and standard care in HbA1c (mean difference −0.79 mmol/mol, 95% confidence interval [CI] = −5.75 to 4.18) or for any of the secondary outcomes. The competency level of D6 nurses was below the beginner proficiency level and similar to the standard-care nurses.ConclusionTraining nurses in MI and basic CBT to support self-management did not lead to improvements in glycaemic control or other secondary outcomes in people with T2D at 18 months. It was also unlikely to be cost-effective. Furthermore, the increased contact with standard-care nurses did not improve glycaemic control.

Aims Impaired awareness of hypoglycaemia (IAH) in people with type 1 diabetes is a dangerous condition that is associated with a six-fold greater risk of severe hypoglycaemia than for people with awareness. A new psychoeducational programme, DAFNE-HART, has been specifically designed to address persistent IAH. The initial pilot showed promising outcomes including fewer hypoglycaemic episodes and improved hypoglycaemia awareness. This aim of this paper is to report the development and qualitative evaluation of DAFNE-HART from participant interviews. Methods DAFNE-HART incorporates diabetes education with two psychological approaches that have demonstrated efficacy in long-term health conditions: motivational interviewing and cognitive behaviour therapy. The course, delivered across two UK locations included both group and individual support over a 6-week period facilitated by DAFNE educators, trained and supervised by a clinical psychologist. Semi-structured interviews were conducted with 19 participants immediately after their courses and the interviews were analysed using grounded theory. Results Five main themes emerged which describe the behavioural changes people made to their diabetes management, the development of new attitudes and beliefs, their experiences of regaining hypoglycaemia cues, reactions to the course format and the significance of the relationship with their care provider. Participants provide insights into how the course changed their view of IAH and led to practical changes in minimising hypoglycaemia. Conclusions Integration of psychological techniques into diabetes education can address the cognitive and motivational barriers to restoring awareness and optimal diabetes management. It is suggested that further research is needed to evaluate this programme in a larger sample, over a longer time frame.

Objectives The effects of heart attack, or myocardial infarction (MI), across psychosocial domains may be particularly acute in younger adults, for whom serious health events are non-normative. MI morbidity is declining in Western countries, but in England MI numbers have plateaued for the under-45 cohort, where approximately 90% of patients are male. Qualitative research on younger adults’ experience of MI is limited, and no study has sampled exclusively under-45s. This study aimed to understand how a sample of men under 45 adjusted to and made sense of MI. Design Qualitative research design based on semi-structured in-depth interviews. Methods Ten men aged under 45 who had experienced MI in the past 3–6 months were purposively recruited and interviewed. Interviews were transcribed verbatim and analysed using interpretative phenomenological analysis. Results Seven superordinate themes were identified. This article focuses in depth on the three most original themes: (1) ‘I'm less of a man’, which described experiences of losing ‘maleness’ (strength, independence, ability to provide) post-MI; (2) ‘Shortened horizons’, which covered participants’ sense of foreshortened future and consequent reprioritization; and (3) ‘Life loses its colour’, describing the loss of pleasure from lifestyle-related changes. Conclusion Themes broadly overlapped with the qualitative literature on younger adult MI. However, some themes (e.g., loss of ‘maleness’ post-MI, and ambivalence towards MI risk factors) appeared unique to this study. Themes were also discussed in relation to risk factors for anxiety and depression and how this might inform clinical care for a younger, male population. Statement of contribution What is already known on this subject? Myocardial infarction (MI) morbidity is not declining in England for under-45s. Adjustment to MI is particularly challenging for younger adults, perhaps because it is non-normative. However, little is known about the experience of MI in younger adults. What does this study add? This is the first qualitative study to sample MI patients exclusively under 45, thereby mapping to epidemiological trends. Further support is provided for some themes identified in the existing young adult MI literature. New themes are identified here which can provide insights relevant to clinical care in this population.

BackgroundMany adults with type 1 diabetes cannot self-manage their diabetes effectively and die prematurely with diabetic complications as a result of poor glucose control. Following the positive results obtained from a randomised controlled trial (RCT) by the Dose Adjustment For Normal Eating (DAFNE) group, published in 2002, structured training is recommended for all adults with type 1 diabetes in the UK.AimWith evidence that blood glucose control is not always improved or sustained, we sought to determine factors explaining why some patients benefit from training more than other patients, identifying barriers to successful self-management, while developing other models to make skills training more accessible and effective.FindingsWe confirmed that glycaemic outcomes are not always improved or sustained when the DAFNE programme is delivered routinely, although improvements in psychosocial outcomes are maintained. DAFNE courses and follow-up support is needed to help participants instil and habituate key self-management practices such as regular diary/record keeping. DAFNE graduates need structured professional support following training. This is currently either unavailable or provided ad hoc without a supporting evidence base. Demographic and psychosocial characteristics had minimal explanatory power in predicting glycaemic control but good explanatory power in predicting diabetes-specific quality of life over the following year. We developed a DAFNE course delivered for 1 day per week over 5 weeks. There were no major differences in outcomes between this and a standard 1-week DAFNE course; in both arms of a RCT, glycaemic control improved by less than in the original DAFNE trial. We piloted a course delivering both the DAFNE programme and pump training. The pilot demonstrated the feasibility of a full multicentre RCT and resulted in us obtaining subsequent Health Technology Assessment programme funding. In collaboration with the National Institute for Health Research (NIHR) Diabetes Research Programme at King’s College Hospital (RG-PG-0606-1142), London, an intervention for patients with hypoglycaemic problems, DAFNE HART (Dose Adjustment for Normal Eating Hypoglycaemia Awareness Restoration Training), improved impaired hypoglycaemia awareness and is worthy of a formal trial. The health economic work developed a new type 1 diabetes model and confirmed that the DAFNE programme is cost-effective compared with no structured education; indeed, it is cost-saving in the majority of our analyses despite limited glycated haemoglobin benefit. Users made important contributions but this could have been maximised by involving them with grant writing, delaying training until the group was established and funding users’ time off work to maximise attendance. Collecting routine clinical data to conduct continuing evaluated roll-out is possible but to do this effectively requires additional administrator support and/or routine electronic data capture.ConclusionsWe propose that, in future work, we should modify the current DAFNE curricula to incorporate emerging understanding of behaviour change principles to instil and habituate key self-management behaviours that include key DAFNE competencies. An assessment of numeracy, critical for insulin dose adjustment, may help to determine whether or not additional input/support is required both before and after training. Models of structured support involving professionals should be developed and evaluated, incorporating technological interventions to help overcome the barriers identified above and enable participants to build effective self-management behaviours into their everyday lives.Trial registrationClinicalTrials.gov NCT01069393.FundingThe NIHR Programme Grants for Applied Research programme.

Many people with type 1 diabetes do not achieve optimal treatment targets despite high patient and professional input. To investigate the reasons underlying suboptimal control we have studied clinical characteristics and self-management behaviours in adults with type 1 diabetes attending a large treatment centre.A questionnaire-based enquiry into self-care behaviours of 380 patients with type 1 diabetes (mean age: 48 (±15) years and mean duration of diabetes: 26 (±15) years), linked with validated measures of impact of treatment on perceived health and hypoglycaemia recognition (Insulin Treatment Satisfaction Questionnaire; and EuroQoL EQ-5D, Gold score) and retrospective case note review of biomedical parameters. The data were analysed using chi-square test, ANOVA, ANCOVA and post-hoc procedures (Tukey's-b) in SPSS-version 18. The minimum significance level was accepted as 0.05.Sixty three percent of participants used multiple daily injections; 36% continuous subcutaneous insulin infusion. Mean HbA1c was 7.7% (±1.2) [61±-10mmol/mol]; 30% had impaired hypoglycaemia awareness (IHA). Factors significantly related to poor glycaemic control with IHA were longer duration of diabetes (p=0.01); less frequent glucose self-monitoring (p=0.05); and low level of patient-set glucose targets (p0.001). Patients with IHA and poorer control had significantly lower insulin treatment satisfaction (p0.001); and perceived health (p0.001).Suboptimal biomedical outcomes in adults with type 1 diabetes attending a specialist intensified insulin therapy clinic are associated with longer duration of diabetes, fewer self-management behaviours and a trend towards poorer perceived health. These data suggest a need for greater emphasis on integration of psychological and self-management support with intensive medical management of type 1 diabetes.

OBJECTIVE To develop and pilot a novel intervention addressing motivational and cognitive barriers to avoiding hypoglycemia in people with type 1 diabetes and persistent impaired awareness of hypoglycemia (IAH) despite training in flexible insulin therapy. RESEARCH DESIGN AND METHODS A 6-week intervention using motivational interviewing and cognitive behavioral techniques was designed. Diabetes educators were trained and supported in its delivery to 23 people with IAH (Gold score ≥4). RESULTS Twelve months postcourse, hypoglycemia awareness had improved (P < 0.001). Median (range) rates of severe hypoglycemia (SH) fell from 3 (0–104) to 0 (0–3) per person per year (P < 0.0001) and moderate from 14 (0–100) to 0 (0–18) per person per 6 weeks (P < 0.001). Worry and behavior around hyperglycemia improved. HbA1c was unchanged. CONCLUSIONS A pilot intervention targeting motivation and cognitions around hypoglycemia engaged patients with resistant IAH and recurrent SH and was associated with significant improvement, supporting the hypothesis that these factors underpin problematic hypoglycemia.

We investigated the adherence of mental health professionals to a Mindfulness-Based Cognitive Therapy (MBCT) programme as well as the impact of MBCT on mindful awareness and attention, psychological well-being and distress, state and trait anxiety, worry and satisfaction with life. The design comprised of a prospective uncontrolled intervention study with pre- and post-measurements of meditation adherence and measures of psychological well-being. Twenty-seven mental health professionals participated in an 8-week MBCT programme for relapse prevention of depression, modified for healthy individuals. Their homework, mindful awareness and attention (Mindful Awareness and Attention Scale), general psychological well-being (General Health Questionnaire), state and trait anxiety (State-Trait Anxiety Inventory), satisfaction with life (Satisfaction with Life Scale), general psychopathology (Brief Symptom Inventory) as well as worry (Penn State Worry Questionnaire) were measured at week 1 and 8 during the intervention and at week 20 as follow-up. Twenty four of 27 (88 %) mental health professionals completed the course and were included in the analysis. Of these, 75 % (18 of 24) were female with a mean age of 36 years and a mean experience in cognitive behavioural therapy (CBT) of 6 years. Sixty-three per cent (15 of 24) reported continued practice at 20-week follow-up. A statistically significant improvement of mindful awareness and psychological well-being, with significant reduction in worry, trait anxiety and general psychopathology, was observed in participants who continued some form of meditation practice during the follow-up period. The majority of mental health professionals adhered to the MBCT meditation practice, and the more they practised mindfulness meditation, the more they experienced an increase in mindful awareness and attention, general psychological well-being and a decrease in general psychopathology, trait anxiety and worry. © 2012 Springer Science+Business Media, LLC.

OBJECTIVE Hypoglycemia unawareness (HU) affects ∼25% of people with type 1 diabetes. People with HU are often reliant on family to detect hypoglycemia and treat severe episodes. We explored the impact of HU on family members’ lives, their involvement in preventing and managing hypoglycemia, and their information and support needs. RESEARCH DESIGN AND METHODS This study employed an exploratory, qualitative design comprising in-depth interviews with 24 adult family members of persons with type 1 diabetes and HU. RESULTS Family members described restricting their lives so that they could help the person with HU detect and treat hypoglycemia. Some described being very physically afraid of their partner/relative when they had a hypoglycemic episode due to their aggressive and argumentative behavior and personality changes; this could also make treatment administration difficult. Family members also reported feeling anxious and worried about the safety of the person with HU, particularly when they were left unsupervised. These concerns were often precipitated by traumatic events, such as discovering the person with HU in a coma. Family members could neglect their own health and well-being to care for the person with HU and resentment could build up over time. Family members highlighted extensive, unmet needs for information and emotional support; however, some struggled to recognize and accept their own need for help. CONCLUSIONS Our findings reveal a caregiver group currently “in the shadow of the patient” and in urgent need of information and emotional support. Raising awareness among health care professionals is essential, and developing proactive support for family should be considered.

The aims of this study were (a) to explore the long-term impact of attending a Mindfulness Based Cognitive Therapy (MBCT) programme upon the personal and professional lives of a sample of clinical psychologists and (b) to assess how their experiences might inform existing theoretical and practical discussions around training for MBCT facilitators. Semi-structured interviews were conducted with seven clinical psychologists who had attended an MBCT programme some 18 months earlier. The transcribed interviews were analysed using Interpretative Phenomenological Analysis. None of the participants was following a regular, formal, meditation practice and for most this was a barrier to facilitating their own groups. Instead, participants described using mindfulness in a more informal, ad hoc, way to enhance pleasant experiences and/or deal with stressful situations. Mindfulness was associated with being able to de-centre from strong emotions and feel more grounded, although some equated this with avoidance. Participants used elements of MBCT with their clients tentatively. The results suggest that attending an MBCT programme is associated with perceived benefits for clinical psychologists. However, some core principles of MBCT such as non-judgemental awareness, compassion, and regular formal practice seem more elusive from these accounts. Further research is needed to establish the importance of these elements and their impact on the training requirements for MCBT facilitators.

Background Antipsychotic depot medications improve medication adherence by reducing covert nonadherence, but some clinicians believe that they are unacceptable to patients. This cross-sectional study investigated patients' perspectives on factors influencing adherence to antipsychotics, from both those taking depots and those taking tablets in ongoing voluntary outpatient care. The study is novel in also encompassing such factors as injection phobia and perceived coercion regarding medication in relation to self-reported adherence. Method Seventy-three patients with schizophrenia/schizoaffective disorder (ICD-10 criteria) completed structured clinical interviews that included the Rating of Medication Influences (ROMI) scale as well as instruments that assessed patients' functioning, psychopathology, insight, extrapyramidal symptoms, quality of life, needle anxiety, experience of coercion, and beliefs about medication. Results Participants taking depot (vs. oral) medication had higher ROMI noncompliance mean scores (15.7 vs. 14.4, p = .019). Predictive factors for influences on noncompliance included certain beliefs regarding medication (concern and overuse) but not extrapyramidal symptoms. There were no differences between the 2 formulation groups on the ROMI compliance subscale. Further predictive factors associated with influences on compliance included perceived necessity. Conclusions Previously, side effects were considered to be a reason for nonadherence to depot more than for oral medications, but our findings do not support this. Rather, beliefs and attitudes are more important than side effects in predicting self-reported adherence and influencing factors thereof. Prescribing a depot medication to enhance relapse prevention will not in itself ensure adherence and therefore must also be accompanied by discussion regarding adherence and associated personal benefits.

BACKGROUND: Interventions targeting multiple risk factors for cardiovascular disease (CVD), including poor diet and physical inactivity, are more effective than interventions targeting a single risk factor. A motivational interviewing (MI) intervention can provide modest dietary improvements and physical activity increases, while adding cognitive behaviour therapy (CBT) skills may enhance the effects of MI. We designed a randomised controlled trial (RCT) to examine whether specific behaviour change techniques integrating MI and CBT result in favourable changes in weight and physical activity in those at high risk of CVD. A group and individual intervention will be compared to usual care. A group intervention offers potential benefits from social support and may be more cost effective. METHODS/DESIGN: Individuals aged between 40 and 74 years in 11 South London Clinical Commissioning Groups who are at high risk of developing CVD (≥20%) in the next 10 years will be recruited. A sample of 1,704 participants will be randomised to receive the enhanced MI intervention, delivered by trained healthy lifestyle facilitators (HLFs), in group or individual formats, in 10 sessions (plus an introductory session) over one year, or usual care. Randomisation will be conducted by King's College London Clinical Trials Unit and researchers collecting outcome data will be blinded to treatment allocation. At 12-month and 24-month follow-up assessments, primary outcomes will be change in weight and physical activity (average steps per day). Secondary outcomes include changes in low-density lipoprotein cholesterol and CVD risk score. Incidence of CVD events since baseline will be recorded. A process evaluation will be conducted to evaluate factors which impact on delivery, adherence and outcome. An economic evaluation will estimate relative cost-effectiveness of each type of intervention delivery. DISCUSSION: This RCT assesses the effectiveness of a healthy lifestyle intervention for people at high risk of CVD. Benefits of the study include the ethnic and socioeconomic diversity of the study population and that, via social support within the group setting and long-term follow-up period, the intervention offers the potential to support maintenance of a healthy lifestyle. TRIAL REGISTRATION: This trial is registered with the ISRCTN registry (identifier: ISRCTN84864870, registered 15 May 2012).