Nicole de Zoysa

A Psychoeducational Program to Restore Hypoglycemia Awareness: The DAFNE-HART Pilot Study

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.

Experiences, Views, and Support Needs of Family Members of People With Hypoglycemia Unawareness: Interview Study

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.

Poorer glycaemic control in type 1 diabetes is associated with reduced self-management and poorer perceived health: A cross-sectional study

AIMS 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. METHODS 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 (Tukeys-b) in SPSS-version 18. The minimum significance level was accepted as 0.05. RESULTS 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 (p<0.001). Patients with IHA and poorer control had significantly lower insulin treatment satisfaction (p<0.001); and perceived health (p<0.001). CONCLUSIONS 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.

Comparing the effectiveness of an enhanced MOtiVational intErviewing InTervention (MOVE IT) with usual care for reducing cardiovascular risk in high risk subjects: study protocol for a randomised controlled trial

BackgroundInterventions 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/DesignIndividuals 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.DiscussionThis 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 registrationThis trial is registered with the ISRCTN registry (identifier: ISRCTN84864870, registered 15 May 2012).

Nurse-led psychological intervention for type 2 diabetes: a cluster randomised controlled trial (Diabetes-6 study) in primary care

BACKGROUND Suboptimal glycaemic control in type 2 diabetes (T2D) is common and associated with psychological barriers. AIM To 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 SETTING Two-arm, single-blind, parallel cluster randomised controlled trial in primary care. METHOD Adult 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. RESULTS Using 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. CONCLUSION Training 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.

A qualitative evaluation of DAFNE-HART: A psychoeducational programme to restore hypoglycaemia awareness

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.

Mobilising knowledge between practitioners and researchers to iteratively refine a complex intervention (DAFNEplus) pre-trial: protocol for a structured, collaborative working group process.

BackgroundRandomised 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.MethodsThis 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.DiscussionThe 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.

Assessing treatment fidelity and contamination in a cluster randomised controlled trial of motivational interviewing and cognitive behavioural therapy skills in type 2 diabetes

BackgroundCompetencies 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.MethodsTwenty-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.ResultsAfter 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%).ConclusionsAfter 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 registrationISRCTN75776892; date registered: 19/05/2010.

A qualitative evaluation of DAFNE-HART

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.