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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 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.