Kingshuk Pal

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.

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.

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

BackgroundSelf-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/DesignThis 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.DiscussionThis 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.

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.

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.

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.

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)

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

BackgroundEvidence 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.MethodsThe 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.ResultsA 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.ConclusionThis 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.