Initiation of antidepressant medication in people with type 2 diabetes living in the UK – a retrospective cohort study

INTRODUCTION: Depression is a common comorbidity in people with type 2 diabetes and it is associated with poorer outcomes. There is limited data on the treatments used for depression in this population. The aim of this study was to explore the rates of initiation of antidepressant prescriptions in people with type 2 diabetes in the UK and identify those most at risk of needing such treatment. RESEARCH DESIGN AND METHODS: This was a retrospective cohort study using data from IQVIA Medical Research Data (IMRD)-UK data. Data from general practices in IMRD-UK between January 2008 and December 2017 were used for this study. RESULTS: The overall rates of antidepressant prescribing were stable over the study period. The rate of initiation of antidepressant medication in people with type 2 diabetes was 22.93 per 1000 person years at risk (PYAR) with a 95%CI 22.48 to 23.39 compared to 16.89 per 1000 PYAR (95%CI 16.77 to 17.01) in an age and gender matched cohort. The risk of being prescribed anti-depressant medication with age had a U-shaped distribution with the lowest risk in the 65-69 age group. The peak age for antidepressant initiation in men and women was 40-44, with a rate in men of 32.78 per 1000 PYAR (95% CI 29.57 to 36.34) and a rate in women of 46.80 per 1000 PYAR (95% CI 41.90 to 52.26). People with type 2 diabetes with in the least deprived quintile had an initiation rate of 19.66 per 1000 PYAR (95%CI 18.67 to 20.70) compared to 27.19 per 1000 PYAR (95%CI 25.50 to 28.93) in the most deprived quintile, with a 32% increase in the risk of starting antidepressant medication (95%CI 1.22 to 1.43). CONCLUSIONS: People with type 2 diabetes were 30% more likely to be started on antidepressant medication than people without type 2 diabetes. Women with type 2 diabetes were 35% more likely than men to be prescribed antidepressants and the risks increased with deprivation and in younger or older adults, with the lowest rates in the 65-69 year age band. The rates of antidepressant prescribing were broadly stable over the 10-year period in this study. The anti-depressant medications prescribed changed slightly over time with sertraline becoming more widely used and fewer prescriptions of citalopram

Incident type 2 diabetes and risk of fracture: a comparative cohort analysis using UK primary care records

Objective: To estimate risk of fracture in men and women with recent diagnosis of type 2 diabetes compared to individuals without diabetes. Research Design and Methods: In this cohort study we used routinely-collected UK primary care data from The Health Improvement Network. In adults (>35 years) diagnosed with type 2 diabetes between 2004-2013 fractures sustained until 2019 were identified and compared to fractures sustained in individuals without diabetes. Multivariable models estimated time to first fracture following diagnosis of diabetes. Annual prevalence rates included at least one fracture in a given year. Results: Among 174,244 individuals with incident type 2 diabetes and 747,290 without diabetes, there was no increased risk of fracture among males with diabetes (adjusted hazards ratio (aHR) 0.97 (95%CI 0.94, 1.00)) and a small reduced risk among females (aHR 0.94, (95%CI 0.92, 0.96)). In those aged 85 years and over those in the diabetes cohort were at significantly lower risk of incident fracture (Males: aHR 0.85, 95%CI 0.71, 1.00; Females: aHR 0.85, 95%CI 0.78, 0.94). For those in the most deprived areas, aHRs were 0.90 (95%CI 0.83, 0.98) for males and 0.91 (95%CI 0.85, 0.97) for females. Annual fracture prevalence rates, by sex, were similar for those with and without type 2 diabetes.Conclusion: We found no evidence to suggest a higher risk of fracture following diagnosis of type 2 diabetes. After a diagnosis of type 2 diabetes individuals should be encouraged to make positive lifestyle changes, including undertaking weight-bearing physical activities that improve bone health

Developing an implementation strategy for a digital health intervention: an example in routine healthcare.

BACKGROUND: Evidence on how to implement new interventions into complex healthcare environments is often poorly reported and indexed, reducing its potential to inform initiatives to improve healthcare services. Using the implementation of a digital intervention within routine National Health Service (NHS) practice, we provide an example of how to develop a theoretically based implementation plan and how to report it transparently. In doing so we also highlight some of the challenges to implementation in routine healthcare. METHODS: The implemented intervention was HeLP-Diabetes, a digital self-management programme for people with Type 2 Diabetes, which was effective in improving diabetes control. The target setting for the implementation was an inner city London Clinical Commissioning Group in the NHS comprised of 34 general practices. HeLP-Diabetes was designed to be offered to patients as part of routine diabetes care across England. Evidence synthesis, engagement of local stakeholders, a theory of implementation (Normalization Process Theory), feedback, qualitative interviews and usage data were used to develop an implementation plan. RESULTS: A new implementation plan was developed to implement HeLP-Diabetes within routine practice. Individual component strategies were selected and developed informed by Normalization Process Theory. These strategies included: engagement of local opinion leaders, provision of educational materials, educational visits, educational meetings, audit and feedback and reminders. Additional strategies were introduced iteratively to address barriers that arose during the implementation. Barriers largely related to difficulties in allocating resources to implement the intervention within routine care. CONCLUSION: This paper provides a worked example of implementing a digital health intervention. The learning from this work can inform others undertaking the work of planning and executing implementation activities in routine healthcare. Of particular importance is: the selection of appropriate theory to guide the implementation process and selection of strategies; ensuring that enough attention is paid to planning implementation; and a flexible approach that allows response to emerging barriers

Health care professionals' views towards self-management and self-management education for people with type 2 diabetes

OBJECTIVES: Significant problems with patients engaging with diabetes self-management education (DSME) exist. The role of healthcare professionals (HCPs) has been highlighted, with a lack of enthusiasm, inadequate information provision and poor promotion of available programmes all cited as affecting patients' decisions to attend. However, little is known about HCPs' views towards DSME. This study investigates the views of HCPs towards self-management generally and self-management in the context of DSME more specifically. DESIGN: A qualitative study using semi-structured interviews to investigate HCPs views of type 2 diabetes self-management and DSME. Data were analysed thematically and emergent themes were mapped on to the constructs of Normalisation Process Theory (NPT). SETTING: Two boroughs in London, UK. PARTICIPANTS: Sampling was purposive to recruit a diverse range of professional roles including GPs, practice nurses, diabetes specialist nurses, healthcare assistants (HCAs), receptionists and commissioners of care. RESULTS: Interviews were conducted with 22 participants. The NPT analysis demonstrated that while a self-management approach to diabetes care was viewed by HCPs as necessary and, in principle, valuable, the reality is much more complex. HCPs expressed ambivalence about pushing certain patients into self-managing, preferring to retain responsibility. There was a lack of awareness among HCPs about the content of DSME and benefits to patients. Commitment to and engagement with DSME was tempered by concerns about suitability for some patients. There was little evidence of communication between providers of group-based DSME and HCPs or of HCPs engaging in work to follow-up non-attenders. CONCLUSIONS: HCPs have concerns about the appropriateness of DSME for all patients and discussed challenges to engaging with and performing the tasks required to embed the approach within practice. DSME, as a means of supporting self-management, was considered important in theory, but there was little evidence of HCPs seeing their role as extending beyond providing referrals

HeLP-Diabetes:randomised controlled trial protocol

Background: Type 2 Diabetes Mellitus (T2DM) is common, affecting nearly 400 million people worldwide. Achieving good health for people with T2DM requires active self-management; however, uptake of self-management education is poor, and there is an urgent need to find better, more acceptable, cost-effective methods of providing self-management support. Web-based self-management support has many potential benefits for patients and health services. The aim of this trial is to determine the effectiveness and cost-effectiveness of a web-based self-management support programme for people with T2DM.Methods: This will be a multi-centre individually randomised controlled trial in primary care, recruiting adults with T2DM who are registered with participating general practices in England. Participants will be randomised to receive either an evidence-based, theoretically informed, web-based self-management programme for people with T2DM which addresses medical, emotional, and role management, called Healthy Living for People with type 2 Diabetes (HeLP-Diabetes) or a simple information website. The joint primary outcomes are glycated haemoglobin (HbA1c) and diabetes-related distress, measured by the Problem Areas In Diabetes (PAID) questionnaire. Secondary outcomes include cardiovascular risk factors, depression and anxiety, and self-efficacy for self-management of diabetes. Health economic data include health service use, costs due to the intervention, and EQ-5D for calculation of Quality Adjusted Life Years (QALYS). Data will be collected at baseline, 3 months and 12 months, with the primary endpoint at 12 months. Practice nurses, blinded to patient allocation, collect clinical data; patients complete online questionnaires for patient reported measures. A sample size of 350 recruited participants allows for attrition of up to 15 % and will provide 90 % power of detecting at a 5 % significance level a true average difference in the PAID score of 4.0 and 0.25 % change in HbA1c (both small effect sizes). The analysis will follow a pre-specified analysis plan, based on comparing the groups as randomised (intention-to-treat).Discussion: The findings of this trial are likely to be of interest to policy makers, clinicians, and commissioners, all of whom are actively seeking additional forms of self-management support for people with T2DM.Trial registration: The Trial Registration number is ISRCTN 02123133; date of registration 14.2.13.<br/

A digital self-management intervention for adults with type 2 diabetes: Combining theory, data and participatory design to develop HeLP-Diabetes.

BACKGROUND: Digital health interventions have potential to contribute to better health outcomes, better healthcare and lower costs. However, evidence for their effectiveness is variable. The development and content of digital health interventions are often not described in enough detail to enable others to replicate the research or improve on previous interventions. This has led to a call for transparent reporting of intervention content and development. PURPOSE: To describe the development process and content of a digital self-management intervention for people with type 2 diabetes (HeLP-Diabetes) that has been found to achieve its target clinical outcome, the reduction of HbA1c, a measure of glycaemic control. METHOD: We synthesised theory, data from existing research evidence and international guidelines, and new qualitative data from target users to identify the determinants of self-management and the content to be included in HeLP-Diabetes. Using an ongoing iterative participatory design approach the content of the intervention was written, produced, reviewed and changed. CONCLUSION: It is possible to develop and transparently report self-management programmes for long-term conditions, which reflect current best evidence, theoretical underpinning and user involvement. We intend that reporting the development process and content will inform future digital intervention development

Web-based self-management support for people with type 2 diabetes (HeLP-Diabetes):randomised controlled trial in English primary care

Objective: To determine the effectiveness of a web-based self-management programme for people with type 2 diabetes in improving glycaemic control and reducing diabetes-related distress. Methods Design: Individually randomised two-arm controlled trial Setting: 21 General Practices in England Participants: Adults aged 18 or over with a diagnosis of type 2 diabetes registered with participating general practices Intervention and comparator: Usual care plus either HeLP-Diabetes, an interactive, theoretically informed, web-based self-management programme or a simple, text-based website containing basic information only. Outcomes and data collection: Joint primary outcomes were glycated haemoglobin (HbA1c) and diabetes-related distress, measured by the Problem Areas in Diabetes (PAID) scale, collected at 3 and 12 months after randomisation, with 12 months the primary outcome point. Research nurses, blind to allocation collected clinical data; participants completed self-report questionnaires online. Analysis: The analysis compared groups as randomised (intention to treat) using a linear mixed effects model, adjusted for baseline data with multiple imputation of missing values. Results Of the 374 participants randomised between September 2013 and December 2014, 185 were allocated to the intervention and 189 to the control. Final (12 month) follow up data for HbA1c were available for 318 (85%) and for PAID 337 (90%) of participants. Of these, 291 (78%) and 321 (86%) responses were recorded within the pre-defined “window” of 10-14 months. Participants in the intervention group had lower HbA1c than those in the control (mean difference -0.24%; 95% Confidence Interval -0.44 to -0.049; p=0.014). There was no significant overall difference between groups in the mean PAID score (p=0.21), but pre-specified subgroup analysis of participants who had had diabetes for less than 7 years showed a beneficial impact of the intervention in this group (p = 0.004). There were no reported harms. Conclusions Access to HeLP-Diabetes improved glycaemic control over 12 months