Initiation of antidepressant medication in people with type 2 diabetes living in the United Kingdom-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 antidepressant 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 antidepressant medications prescribed changed slightly over time with sertraline becoming more widely used and fewer prescriptions of citalopram.

Mild cognitive impairment and progression to dementia in people with diabetes, prediabetes and metabolic syndrome: a systematic review and meta-analysis.

PURPOSE: We aimed to quantify the relative risk of progression from mild cognitive impairment (MCI) to dementia in people with and without diabetes, and with and without the MetS (MetS); and to identify potential modifiers of the risk of progression from MCI to dementia in people with diabetes or MetS. METHODS: We searched Medline, Embase, PsycINFO, PsycArticles and Web of Science from inception through to 20th March 2018. Where possible, the results from three or more studies were pooled in a meta-analysis, while other findings have been described narratively. RESULTS: We included 15 articles reporting 12 studies (6865 participants). The overall unadjusted pooled odds ratio for the progression of MCI to dementia in people with diabetes/MetS was 1.67 (95% CI 1.27-2.19); the pooled odds ratio for progression in diabetes + MCI was 1.53 (95% CI 1.20-1.97) and in people with MetS + MCI was 2.95 (95% CI 1.23-7.05). There was moderate heterogeneity in the included studies (I2 < 60%). In diabetes, a longer duration of diabetes and the presence of retinopathy were associated with an increased risk of progression, while the use of statins and oral hypoglycaemic agents reduced the risk. Having multiple cardiovascular risk factors was a significant risk factor for progression from MCI to dementia in people with MetS. CONCLUSIONS: Diabetes and MetS were both associated with an increased incidence of dementia when co-existing with MCI. Intensive cardiovascular risk reduction and lifestyle changes for patients presenting with MCI and diabetes, prediabetes or MetS may be important in reducing incidence of dementia in this high risk population.

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.

Digital Health Interventions for Adults With Type 2 Diabetes: Qualitative Study of Patient Perspectives on Diabetes Self-Management Education and Support.

BACKGROUND: The prevalence of type 2 diabetes is increasing globally, and health services in many countries are struggling with the morbidity, mortality, and costs associated with the complications of this long-term condition. Diabetes self-management education (DSME) and behavioral support can reduce the risks of developing diabetes-related complications and improve glycemic control. However, their uptake is low. Digital health interventions (DHI) can provide sustained support and may overcome challenges associated with attending diabetes self-management sessions. They have the potential for delivery at multiple locations at convenient times, anonymity, and presentation of content in attractive and tailored formats. This study investigates the needs and wants of patients with type 2 diabetes to inform the development of digital self-management education and support. OBJECTIVE: The objective of this study was to explore patient perspectives on unmet needs for self-management and support and the role of DHI in adults living with type 2 diabetes. METHODS: This study used a qualitative approach based on data generated from 4 focus groups with 20 patients. RESULTS: The data generated by the focus groups illustrated the significant burden that the diagnosis of diabetes places on many patients and the negative impacts on their emotional well-being, work, social life, and physical health. Although patients' experiences of the health care services varied, there was agreement that even the best services were unable to meet all users' needs to support the emotional regulation, psychological adjustment, and behavioral changes needed for successful self-management. CONCLUSIONS: By focusing on medical management and information provision, existing health care services and education programs may not be adequately meeting all the needs of patients with type 2 diabetes. DHIs have the potential to improve access to DSME and behavioral support and extend the range of content offered by health services to fit with a wider range of patient needs. Features that could help DHIs address some of the unmet needs described by participants in this study included placing an emphasis on emotional and role management, being available at all times, having up-to-date evidence-based guidance for patients, and providing access to peer-generated and professional advice.

Cost-Effectiveness of Facilitated Access to a Self-Management Website, Compared to Usual Care, for Patients With Type 2 Diabetes (HeLP-Diabetes): Randomized Controlled Trial.

BACKGROUND: Type 2 diabetes mellitus is one of the most common long-term conditions, and costs health services approximately 10% of their total budget. Active self-management by patients improves outcomes and reduces health service costs. While the existing evidence suggested that uptake of self-management education was low, the development of internet-based technology might improve the situation. OBJECTIVE: To establish the cost-effectiveness of a Web-based self-management program for people with type 2 diabetes (HeLP-Diabetes) compared to usual care. METHODS: An incremental cost-effectiveness analysis was conducted, from a National Health Service and personal and social services perspective, based on data collected from a multi-center, two-arm individually randomized controlled trial over 12 months. Adults aged 18 or over with a diagnosis of type 2 diabetes and registered with the 21 participating general practices (primary care) in England, UK, were approached. People who were unable to provide informed consent or to use the intervention, terminally ill, or currently participating in a trial of an alternative self-management intervention, were excluded. The participants were then randomized to either usual care plus HeLP-Diabetes, an interactive, theoretically-informed Web-based self-management program, or to usual care plus access to a comparator website containing basic information only. The participants' intervention costs and wider health care resource use were collected as well as two health-related quality of life measures: the Problem Areas in Diabetes (PAID) Scale and EQ-5D-3L. EQ-5D-3L was then used to calculate quality-adjusted life years (QALYs). The primary analysis was based on intention-to-treat, using multiple imputation to handle the missing data. RESULTS: In total, 374 participants were randomized, with 185 in the intervention group and 189 in the control group. The primary analysis showed incremental cost-effectiveness ratios of £58 (95% CI -411 to 587) per unit improvement on PAID scale and £5550 (95% CI -21,077 to 52,356) per QALY gained by HeLP-Diabetes, compared to the control. The complete case analysis showed less cost-effectiveness and higher uncertainty with incremental cost-effectiveness ratios of £116 (95% CI -1299 to 1690) per unit improvement on PAID scale and £18,500 (95% CI -203,949 to 190,267) per QALY. The cost-effectiveness acceptability curve showed an 87% probability of cost-effectiveness at £20,000 per QALY willingness-to-pay threshold. The one-way sensitivity analyses estimated 363 users would be needed to use the intervention for it to become less costly than usual care. CONCLUSIONS: Facilitated access to HeLP-Diabetes is cost-effective, compared to usual care, under the recommended threshold of £20,000 to £30,000 per QALY by National Institute of Health and Care Excellence. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN) 02123133; http://www.controlled-trials.com/ISRCTN02123133 (Archived by WebCite at http://www.webcitation.org/6zqjhmn00).

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.

Evaluating the implementation of HeLP-Diabetes within NHS services: study protocol.

BACKGROUND: Self-management by people with type 2 diabetes is central to good health outcomes and the prevention of associated complications. Structured education to teach self-management is recommended by the National Institute for Heath and Clinical Excellence; however, only a small proportion of patients report being offered this education and even fewer attend. This study aims to evaluate the implementation of a new internet-based self-management intervention: HeLP-Diabetes (Healthy Living for People with type 2 Diabetes) within the National Health Service. Specific objectives are to a) determine the uptake and use of HeLP-Diabetes by services and patients; b) identify the factors which inhibit or facilitate use; c) identify the resources needed for effective implementation; d) explore possible effects of HeLP-Diabetes use on self-reported patient outcome measures. METHODS/DESIGN: This study will use an iterative design to implement HeLP-Diabetes into existing health services within the National Health Service. A two stage implementation process will be taken, whereby batches of General Practice surgeries and diabetes clinics will be offered HeLP-Diabetes and will subsequently be asked to participate in evaluating the implementation. We will collect data to describe the number of services and patients who sign up to HeLP-Diabetes, the types of services and patients who sign up and the implementation costs. Semi-structured interviews will be conducted with patients and health professionals and cohorts of patient participants will be asked to complete self-report measures at baseline, 3 months, and 12 months. DISCUSSION: This study will evaluate the implementation of a new online self-management intervention and describe what happens when it is made available to existing National Health Services and patients with type 2 diabetes. We will collect data to describe the uptake and use of the intervention and the resources needed for widespread implementation. We will report on patient benefits from using HeLP-Diabetes and the resources needed to achieve these in routine practice. Interviews with key stake holders will identify, define and explain factors that promote or inhibit the normalization of new patterns of patient and professional activity arising from HeLP-Diabetes.

Computer-based diabetes self-management interventions for adults with type 2 diabetes mellitus.

BACKGROUND: Diabetes is one of the commonest chronic medical conditions, affecting around 347 million adults worldwide. Structured patient education programmes reduce the risk of diabetes-related complications four-fold. Internet-based self-management programmes have been shown to be effective for a number of long-term conditions, but it is unclear what are the essential or effective components of such programmes. If computer-based self-management interventions improve outcomes in type 2 diabetes, they could potentially provide a cost-effective option for reducing the burdens placed on patients and healthcare systems by this long-term condition. OBJECTIVES: To assess the effects on health status and health-related quality of life of computer-based diabetes self-management interventions for adults with type 2 diabetes mellitus. SEARCH METHODS: We searched six electronic bibliographic databases for published articles and conference proceedings and three online databases for theses (all up to November 2011). Reference lists of relevant reports and reviews were also screened. SELECTION CRITERIA: Randomised controlled trials of computer-based self-management interventions for adults with type 2 diabetes, i.e. computer-based software applications that respond to user input and aim to generate tailored content to improve one or more self-management domains through feedback, tailored advice, reinforcement and rewards, patient decision support, goal setting or reminders. DATA COLLECTION AND ANALYSIS: Two review authors independently screened the abstracts and extracted data. A taxonomy for behaviour change techniques was used to describe the active ingredients of the intervention. MAIN RESULTS: We identified 16 randomised controlled trials with 3578 participants that fitted our inclusion criteria. These studies included a wide spectrum of interventions covering clinic-based brief interventions, Internet-based interventions that could be used from home and mobile phone-based interventions. The mean age of participants was between 46 to 67 years old and mean time since diagnosis was 6 to 13 years. The duration of the interventions varied between 1 to 12 months. There were three reported deaths out of 3578 participants.Computer-based diabetes self-management interventions currently have limited effectiveness. They appear to have small benefits on glycaemic control (pooled effect on glycosylated haemoglobin A1c (HbA1c): -2.3 mmol/mol or -0.2% (95% confidence interval (CI) -0.4 to -0.1; P = 0.009; 2637 participants; 11 trials). The effect size on HbA1c was larger in the mobile phone subgroup (subgroup analysis: mean difference in HbA1c -5.5 mmol/mol or -0.5% (95% CI -0.7 to -0.3); P < 0.00001; 280 participants; three trials). Current interventions do not show adequate evidence for improving depression, health-related quality of life or weight. Four (out of 10) interventions showed beneficial effects on lipid profile.One participant withdrew because of anxiety but there were no other documented adverse effects. Two studies provided limited cost-effectiveness data - with one study suggesting costs per patient of less than $140 (in 1997) or 105 EURO and another study showed no change in health behaviour and resource utilisation. AUTHORS' CONCLUSIONS: Computer-based diabetes self-management interventions to manage type 2 diabetes appear to have a small beneficial effect on blood glucose control and the effect was larger in the mobile phone subgroup. There is no evidence to show benefits in other biological outcomes or any cognitive, behavioural or emotional outcomes.

Web-Based Structured Education for Type 2 Diabetes: Interdisciplinary User-Centered Design Approach.

BACKGROUND: Digital health research encompasses methods from human-computer interaction and health research. OBJECTIVE: This paper aims to describe how these methods were combined to develop HeLP-Diabetes: Starting Out, a web-based structured education program for people newly diagnosed with type 2 diabetes. METHODS: The development process consisted of three phases: initial design for effectiveness, optimization for usability, and in the wild testing in the National Health Service with people newly diagnosed with type 2 diabetes, and further revisions. We adopted an iterative user-centered approach and followed steps from the human-computer interaction design life cycle and the Medical Research Council guidelines on developing and evaluating complex interventions. RESULTS: The initial design process resulted in an 8-session program containing information and behavior change techniques targeting weight loss, being more active, and taking medication. The usability testing was highlighted at an early stage, where changes needed to be made to the language and layout of the program. The in the wild testing provided data on uptake of and barriers to use. The study suggested low uptake and completion of the program, but those who used it seemed to benefit from it. The qualitative findings suggested that barriers to use included an expectation that the program would take too long. This informed refinements to the program. CONCLUSIONS: The use of interdisciplinary methods resulted in an iterative development process and refinements to the program that were based on user needs and data on uptake. The final intervention was more suitable for a definitive evaluation than the initial version. The description of our approach informs other digital health researchers on how to make interventions more sensitive to user needs.

Time trends in the incidence of clinically diagnosed type 2 diabetes and pre-diabetes in the UK 2009-2018: a retrospective cohort study.

INTRODUCTION: To describe recent trends in the incidence of clinically diagnosed type 2 diabetes and pre-diabetes in people seen in UK general practice. RESEARCH DESIGN AND METHODS: A retrospective cohort study using IQVIA Medical Research Data looking at people newly diagnosed with type 2 diabetes and pre-diabetes through primary care registers in the UK between 1 January 2009 and 31 December 2018. RESULTS: A cohort of 426 717 people were clinically diagnosed with type 2 diabetes and 418 656 people met the criteria for a diagnosis of pre-diabetes in that time period. The incidence of clinically diagnosed type 2 diabetes per 1000 person years at risk (PYAR) in men decreased from a peak of 5.06 per 1000 PYAR (95% CI 4.97 to 5.15) in 2013 to 3.56 per 1000 PYAR (95% CI 3.46 to 3.66) by 2018. For women, the incidence of clinically diagnosed type 2 diabetes per 1000 PYAR decreased from 4.45 (95% CI 4.37 to 4.54) in 2013 to 2.85 (2.76 to 2.93) in 2018. The incidence rate of pre-diabetes tripled by the end of the same study period in men and women. CONCLUSIONS: Between 2009 and 2018, the incidence rate of new clinical diagnoses of type 2 diabetes recorded in a UK primary care database decreased by a third from its peak in 2013-2014, while the incidence of pre-diabetes has tripled. The implications of this on timely treatment, complication rates and mortality need further longer term exploration.

Cardiovascular outcomes of type 2 diabetic patients treated with DPP­4 inhibitors versus sulphonylureas as add-on to metformin in clinical practice.

DPP-4 inhibitors (DPP-4i) and sulphonylureas remain the most widely prescribed add-on treatments after metformin. However, there is limited evidence from clinical practice comparing major adverse cardiovascular events (MACE) in patients prescribed these treatments, particularly among those without prior history of MACE and from vulnerable population groups. Using electronic health records from UK primary care, we undertook a retrospective cohort study with people diagnosed type-2 diabetes mellitus, comparing incidence of MACE (myocardial infarction, stroke, major cardiovascular surgery, unstable angina) and all-cause mortality among those prescribed DPP-4i versus sulphonylureas as add-on to metformin. We stratified analysis by history of MACE, age, social deprivation and comorbidities and adjusted for HbA1c, weight, smoking-status, comorbidities and medications. We identified 17,570 patients prescribed sulphonylureas and 6,267 prescribed DPP-4i between 2008-2017. Of these, 16.3% had pre-existing MACE. Primary incidence of MACE was similar in patients prescribed DPP-4i and sulphonylureas (10.3 vs 8.5 events per 1000 person-years; adjusted Hazard Ratio (adjHR): 0.94; 95%CI 0.80-1.14). For those with pre-existing MACE, rates for recurrence were higher overall, but similar between the two groups (21.8 vs 17.2 events per 1000 person-years; adjHR: 0.93; 95%CI 0.69-1.24). For those aged over 75 and with BMI less than 25 kg/m2 there was a protective effect for DPP-I, warranting further investigation. Patients initiating a DPP-4i had similar risk of cardiovascular outcomes to those initiating a sulphonylurea. This indicates the choice should be based on safety and cost, not cardiovascular prognosis, when deciding between a DPP-4i or sulphonylurea as add-on to metformin.

Incident Type 2 Diabetes and Risk of Fracture: A Comparative Cohort Analysis Using U.K. Primary Care Records.

OBJECTIVE: To estimate risk of fracture in men and women with recent diagnosis of type 2 diabetes compared with individuals without diabetes. RESEARCH DESIGN AND METHODS: In this cohort study, we used routinely collected U.K. primary care data from The Health Improvement Network. In adults (>35 years) diagnosed with type 2 diabetes between 2004 and 2013, fractures sustained until 2019 were identified and compared with 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 hazard 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, 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. CONCLUSIONS: 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.

Use of the TIDieR checklist to describe an online structured education programme for type 2 diabetes.

OBJECTIVES: The aim of structured education for type 2 diabetes is to improve knowledge, skills and confidence in self-management. It is recommended in the UK for everyone who is newly diagnosed with type 2 diabetes. We developed an on-line programme called HeLP-Diabetes: Starting Out to address poor uptake of face-to-face structured education. The aim of this paper is to describe the intervention in line with the Template for Intervention Description and Replication guide, which calls for better reporting of interventions. METHODS: The Template for Intervention Description and Replication guide provided the item headings for the description. These included the theoretical underpinning, materials, procedures, providers, and mode of delivery. RESULTS: The programme was developed to meet NICE requirements for structured education and therefore followed a structured curriculum with four sessions covering content such as what diabetes is and how it is treated, possible complications, and how lifestyle changes can improve health. Content was delivered in text, images and video, and behaviour change techniques, self-assessment and feedback were used to help people target key health behaviours. The programme was delivered entirely online, but the team were available for support via telephone. Email feedback and reminders were sent. CONCLUSIONS: The TIDieR checklist allowed us to provide a clear structure for the description of the intervention. However, it could not capture the full complexity of the programme, and intervention developers considering using it in the future may find that it needs to be adapted to make it more specific to their intervention.

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.

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.

Promoting Engagement With a Digital Health Intervention (HeLP-Diabetes) Using Email and Text Message Prompts: Mixed-Methods Study.

BACKGROUND: Engagement with digital health interventions (DHIs) may be regarded as a prerequisite for the intervention to achieve positive health or behavior change outcomes. One method employed to promote engagement is the use of prompts such as emails and text messages. However, little is known about the characteristics of prompts that promote engagement. This study explored the association between the content and delivery mode of prompts and the users' engagement with HeLP-Diabetes (Healthy Living for People with type 2 Diabetes), a DHI that aimed to promote self-management in adults with type 2 diabetes. OBJECTIVE: The objective of this study was to identify the characteristics of prompts, specifically the content and delivery mode, which were associated with increased engagement. METHODS: This was a mixed-methods study. Email and text message prompts were sent to the registered users of HeLP-Diabetes. Use of the intervention was recorded and examined to identify which email and text message prompts were associated with subsequent visits to the DHI. Characteristics of prompts that were identified as particularly effective or ineffective were explored through think-aloud interviews with the participants. RESULTS: Of a total of 39 email prompts, 49% (19/39) prompts showed a significant association with subsequent visits to the DHI. However, none of the text message prompts were associated with subsequent visits to the DHI. Furthermore, think-aloud interviews were carried out with 6 experienced participants with type 2 diabetes. The findings suggest that these participants preferred email prompts that were clear, relatively short, and empowering; used nondirective advice; included health professional references; were visually appealing; and contained news and updates. CONCLUSIONS: The findings of this study contribute to the existing evidence supporting the role of email prompts in promoting and maintaining engagement with DHIs. This study described the content of prompts that may be engaging. However, the results should be interpreted with caution, as prompts may be context-specific interventions and the results may not be generalizable across other DHIs or other types of interventions targeting self-management of type 2 diabetes.

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 AND 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 Healthy Living for People with Diabetes (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 predefined window of 10-14 months. Participants in the intervention group had lower HbA1c than those in the control (mean difference -0.24%; 95% CI -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 prespecified subgroup analysis of participants who had been more recently diagnosed with diabetes 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. TRIAL REGISTRATION NUMBER: ISRCTN02123133.

Patient reactions to a web-based cardiovascular risk calculator in type 2 diabetes: a qualitative study in primary care.

BACKGROUND: Use of risk calculators for specific diseases is increasing, with an underlying assumption that they promote risk reduction as users become better informed and motivated to take preventive action. Empirical data to support this are, however, sparse and contradictory. AIM: To explore user reactions to a cardiovascular risk calculator for people with type 2 diabetes. Objectives were to identify cognitive and emotional reactions to the presentation of risk, with a view to understanding whether and how such a calculator could help motivate users to adopt healthier behaviours and/or improve adherence to medication. DESIGN AND SETTING: Qualitative study combining data from focus groups and individual user experience. Adults with type 2 diabetes were recruited through website advertisements and posters displayed at local GP practices and diabetes groups. METHOD: Participants used a risk calculator that provided individualised estimates of cardiovascular risk. Estimates were based on UK Prospective Diabetes Study (UKPDS) data, supplemented with data from trials and systematic reviews. Risk information was presented using natural frequencies, visual displays, and a range of formats. Data were recorded and transcribed, then analysed by a multidisciplinary group. RESULTS: Thirty-six participants contributed data. Users demonstrated a range of complex cognitive and emotional responses, which might explain the lack of change in health behaviours demonstrated in the literature. CONCLUSION: Cardiovascular risk calculators for people with diabetes may best be used in conjunction with health professionals who can guide the user through the calculator and help them use the resulting risk information as a source of motivation and encouragement.

Computer-based interventions to improve self-management in adults with type 2 diabetes: a systematic review and meta-analysis.

OBJECTIVE: Structured patient education programs can reduce the risk of diabetes-related complications. However, people appear to have difficulties attending face-to-face education and alternatives are needed. This review looked at the impact of computer-based diabetes self-management interventions on health status, cardiovascular risk factors, and quality of life of adults with type 2 diabetes. RESEARCH DESIGN AND METHODS: We searched The Cochrane Library, Medline, Embase, PsycINFO, Web of Science, and CINAHL for relevant trials from inception to November 2011. Reference lists from relevant published studies were screened and authors contacted for further information when required. Two authors independently extracted relevant data using standard data extraction templates. RESULTS: Sixteen randomized controlled trials with 3,578 participants met the inclusion criteria. Interventions were delivered via clinics, the Internet, and mobile phones. Computer-based diabetes self-management interventions appear to have small benefits on glycemic control: the pooled effect on HbA1c was -0.2% (-2.3 mmol/mol [95% CI -0.4 to -0.1%]). A subgroup analysis on mobile phone-based interventions showed a larger effect: the pooled effect on HbA1c from three studies was -0.50% (-5.46 mmol/mol [95% CI -0.7 to -0.3%]). There was no evidence of improvement in depression, quality of life, blood pressure, serum lipids, or weight. There was no evidence of significant adverse effects. CONCLUSIONS: Computer-based diabetes self-management interventions to manage type 2 diabetes appear to have a small beneficial effect on blood glucose control, and this effect was larger in the mobile phone subgroup. There was no evidence of benefit for other biological, cognitive, behavioral, or emotional outcomes.