A qualitative analysis of the needs and wishes of people with type 2 diabetes and healthcare professionals for optimal diabetes care.

AIM: Globally, type 2 diabetes care is often fragmented and still organised in a provider-centred way, resulting in suboptimal care for many individuals. As healthcare systems seek to implement digital care innovations, it is timely to reassess stakeholders' priorities to guide the redesign of diabetes care. This study aimed to identify the needs and wishes of people with type 2 diabetes, and specialist and primary care teams regarding optimal diabetes care to explore how to better support people with diabetes in a metropolitan healthcare service in Australia. METHODS: Our project was guided by a Participatory Design approach and this paper reports part of the first step, identification of needs. We conducted four focus groups and 16 interviews (November 2019-January 2020) with 17 adults with type 2 diabetes and seven specialist clinicians from a diabetes outpatient clinic in Brisbane, Australia, and seven primary care professionals from different clinics in Brisbane. Data were analysed using reflexive thematic analysis, building on the Capability, Opportunity, Motivation and Behaviour model. RESULTS: People with diabetes expressed the wish to be equipped, supported and recognised for their efforts in a holistic way, receive personalised care at the right time and improved access to connected services. Healthcare professionals agreed and expressed their own burden regarding their challenging work. Overall, both groups desired holistic, personalised, supportive, proactive and coordinated care pathways. CONCLUSIONS: We conclude that there is an alignment of the perceived needs and wishes for improved diabetes care among key stakeholders, however, important gaps remain in the healthcare system.

Same goals, different challenges: A systematic review of perspectives of people with diabetes and healthcare professionals on Type 2 diabetes care.

AIMS: To identify the views of people with Type 2 diabetes (PWD) and healthcare professionals (HCP) about diabetes care. METHODS: A systematic review of qualitative studies reporting both groups' views using thematic synthesis frameworked by the eHealth Enhanced Chronic Care Model was conducted. RESULTS: We searched six electronic databases between 2010 and 2020, identified 6999 studies and included 21. Thirty themes were identified with in general complementary views between PWD and HCP. PWD and HCP find lifestyle changes challenging and get frustrated when PWD struggle to achieve it. Good self-management requires a trustful PWD-HCP relationship. Diabetes causes distress and often HCP focus on clinical aspects. They value diabetes education. PWD require broader, tailored, consistent and ongoing information, but HCPs do not have enough time for providing it. There is need for diabetes training for primary HCP. Shared decision making can mitigate PWD's fears. Different sources of social support can influence PWD's ability to self-manage and PWD/HCP suggest online peer groups. PWD/HCP indicate lack of communication and collaboration between HCP. PWD's and HCP's views about quality in diabetes care differ. They believe that comprehensive, multidisciplinary and locally provided care can help to achieve better outcomes. They recognise digital health benefits, with room for personal interaction (PWD) and eHealth literacy improvements (HCP). Evidence-based guidelines are important but can detract from personalised care. CONCLUSION: We hypothesise that including PWD's and HCP's complementary views, multidisciplinary teams and digital tools in the redesign of Type 2 diabetes care can help with overcoming some of the challenges and achieving common goals.

My Diabetes Coach, a Mobile App-Based Interactive Conversational Agent to Support Type 2 Diabetes Self-Management: Randomized Effectiveness-Implementation Trial.

BACKGROUND: Delivering self-management support to people with type 2 diabetes mellitus is essential to reduce the health system burden and to empower people with the skills, knowledge, and confidence needed to take an active role in managing their own health. OBJECTIVE: This study aims to evaluate the adoption, use, and effectiveness of the My Diabetes Coach (MDC) program, an app-based interactive embodied conversational agent, Laura, designed to support diabetes self-management in the home setting over 12 months. METHODS: This randomized controlled trial evaluated both the implementation and effectiveness of the MDC program. Adults with type 2 diabetes in Australia were recruited and randomized to the intervention arm (MDC) or the control arm (usual care). Program use was tracked over 12 months. Coprimary outcomes included changes in glycated hemoglobin (HbA1c) and health-related quality of life (HRQoL). Data were assessed at baseline and at 6 and 12 months, and analyzed using linear mixed-effects regression models. RESULTS: A total of 187 adults with type 2 diabetes (mean 57 years, SD 10 years; 41.7% women) were recruited and randomly allocated to the intervention (n=93) and control (n=94) arms. MDC program users (92/93 participants) completed 1942 chats with Laura, averaging 243 min (SD 212) per person over 12 months. Compared with baseline, the mean estimated HbA1c decreased in both arms at 12 months (intervention: 0.33% and control: 0.20%), but the net differences between the two arms in change of HbA1c (-0.04%, 95% CI -0.45 to 0.36; P=.83) was not statistically significant. At 12 months, HRQoL utility scores improved in the intervention arm, compared with the control arm (between-arm difference: 0.04, 95% CI 0.00 to 0.07; P=.04). CONCLUSIONS: The MDC program was successfully adopted and used by individuals with type 2 diabetes and significantly improved the users' HRQoL. These findings suggest the potential for wider implementation of technology-enabled conversation-based programs for supporting diabetes self-management. Future studies should focus on strategies to maintain program usage and HbA1c improvement. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry (ACTRN) 12614001229662; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12614001229662.

Diabetes Care in the Digital Era: a Synoptic Overview.

PURPOSE OF REVIEW: Diabetes care is undergoing a remarkable transformation by the advancements in information and communications technology (ICT). The aim of this review is to provide a general overview of various ICT-based interventions for diabetes care, challenges of their adoption, and consider future directions. RECENT FINDINGS: A number of systematic reviews have examined studies on various aspects of telemedicine and eHealth for diabetes care, but they are generally focused on one specific type of technology application for diabetes care. A wide range of solutions from manual or automated telephone calls, short message services, websites, mobile health apps, remote monitoring devices, and sophisticated artificial intelligence systems has been studied in different settings and scopes with mixed results. However, despite the promising results of research studies, such innovative solutions are not widely adopted by health systems worldwide. Lack of supportive policy and legislation, unsustainable reimbursement, inefficient business models, and concerns regarding the security and privacy of health data are among the most problematic barriers.

User Experience of an Innovative Mobile Health Program to Assist in Insulin Dose Adjustment: Outcomes of a Proof-Of-Concept Trial.

BACKGROUND: Many patients with diabetes require insulin therapy to achieve optimal glycemic control. Initiation and titration of insulin often require an insulin dose adjustment (IDA) program, involving frequent exchange of blood glucose levels (BGLs) and insulin prescription advice between the patient and healthcare team. This process is time consuming with logistical barriers. OBJECTIVE: To develop an innovative mobile health (m-Health) mobile-based IDA program (mIDA) and evaluate the user adherence and experience through a proof-of-concept trial. METHODS: In the program, an m-Health system was designed to be integrated within a clinical IDA service, comprising a Bluetooth-enabled glucose meter, smartphone application, and clinician portal. Insulin-requiring patients with type-2 diabetes mellitus and stable BGL were recruited to use the m-Health system to record and exchange BGL entries, insulin dosages, and clinical messages for 2 weeks. The user experience was evaluated by a Likert scale questionnaire. RESULTS: Nine participants, aged 58 ± 14 years (mean ± SD), completed the trial with average daily records of 3.1 BGL entries and 1.2 insulin dosage entries. The participants recognized the potential value of the clinical messages. They felt confident about managing their diabetes and were positive regarding ease of use and family support of the system, but disagreed that there were no technical issues. Finally, they were satisfied with the program and would continue to use it if possible. CONCLUSIONS: The m-Health system for IDA showed promising levels of adherence, usability, perception of usefulness, and satisfaction. Further research is required to assess the feasibility and cost-effectiveness of using this system in outpatient settings.

Working Together to Improve Type 2 Diabetes Care: A Participatory Design Project to Address Identified Needs of People With Diabetes and Their Health-care Professionals.

OBJECTIVES: Diabetes care in Australia is often fragmented and provider-centred, resulting in suboptimal care. Innovative solutions are needed to bridge the evidence-practice gap, and technology can facilitate the redesign of type 2 diabetes care. We used participatory design to increase the chances of fulfilling stakeholders' needs. Using this method, we explored solutions aimed at redesigning diabetes care, focussing on the previously identified needs. METHODS: The participatory design project was guided by stakeholders' contributions. Stakeholders of this project included people with type 2 diabetes, health-care professionals, technology developers, and researchers. Information uncovered at each step influenced the next: 1) identification of needs, 2) generation of solutions, and 3) testing of solutions. Here, we present steps 2 and 3. In step 2, we presented previously identified issues and elicited creative solutions. In step 3, we obtained stakeholders' feedback on the solutions from step 2, presented as care pathways. RESULTS: Suggested solutions included a multidisciplinary wellness centre, a mobile app, increased access to education, improved care coordination, increased support for general practitioners, and a better funding model. The revised care pathways featured accessible community resources, a tailored self-management and educational app, a care coordinator, a digital dashboard, and specialized support for primary care to deal with complex cases. CONCLUSIONS: Using a participatory design, we successfully identified multiple innovative solutions with the potential to improve person-centred and integrated type 2 diabetes care in Australia. These solutions will inform the implementation and evaluation of a redesigned care model by our team.

Randomised controlled trial of an automated, interactive telephone intervention (TLC Diabetes) to improve type 2 diabetes management: baseline findings and six-month outcomes.

BACKGROUND: Effective self-management of diabetes is essential for the reduction of diabetes-related complications, as global rates of diabetes escalate. METHODS: Randomised controlled trial. Adults with type 2 diabetes (n = 120), with HbA1c greater than or equal to 7.5 %, were randomly allocated (4 × 4 block randomised block design) to receive an automated, interactive telephone-delivered management intervention or usual routine care. Baseline sociodemographic, behavioural and medical history data were collected by self-administered questionnaires and biological data were obtained during hospital appointments. Health-related quality of life (HRQL) was measured using the SF-36. RESULTS: The mean age of participants was 57.4 (SD 8.3), 63% of whom were male. There were no differences in demographic, socioeconomic and behavioural variables between the study arms at baseline. Over the six-month period from baseline, participants receiving the Australian TLC (Telephone-Linked Care) Diabetes program showed a 0.8% decrease in geometric mean HbA(1c) from 8.7% to 7.9%, compared with a 0.2% HbA(1c) reduction (8.9% to 8.7%) in the usual care arm (p = 0.002). There was also a significant improvement in mental HRQL, with a mean increase of 1.9 in the intervention arm, while the usual care arm decreased by 0.8 (p = 0.007). No significant improvements in physical HRQL were observed. CONCLUSIONS: These analyses indicate the efficacy of the Australian TLC Diabetes program with clinically significant post-intervention improvements in both glycaemic control and mental HRQL. These observed improvements, if supported and maintained by an ongoing program such as this, could significantly reduce diabetes-related complications in the longer term. Given the accessibility and feasibility of this kind of program, it has strong potential for providing effective, ongoing support to many individuals with diabetes in the future.

Evaluating a quality improvement collaborative: a hybrid approach.

PURPOSE: Quality improvement collaboratives (QICs) are a popular approach to improving healthcare services and patient outcomes. This paper evaluates a QIC implemented by a large, integrated healthcare organisation in Wales in the UK. DESIGN/METHODOLOGY/APPROACH: This evaluation study draws on two well-established evaluation frameworks: Kirkpatrick's approach to gather data on participant satisfaction and learning and Stake's approach to gather data and form judgements about the impact of the intervention. A mixed methods approach was taken which included documentary analysis, surveys, semi-structured interviews, and observation of the QIC programme. FINDINGS: Together the two frameworks provide a rounded interpretation of the extent to which the QIC intervention was fit-for-purpose. Broadly the evaluation of the QIC was positive with some areas of improvement identified. RESEARCH LIMITATIONS/IMPLICATIONS: This study is limited to a QIC conducted within one organisation. Further testing of the hybrid framework is needed that extends to different designs of QICs. PRACTICAL IMPLICATIONS: A hybrid framework is provided to assist those charged with designing and evaluating QICs. ORIGINALITY/VALUE: Evaluation studies are limited on QICs and if present tend to adopt one framework. Given the complexities of undertaking quality improvement within healthcare, this study uniquely takes a hybrid approach.

Randomised controlled trial of an automated, interactive telephone intervention to improve type 2 diabetes self-management (Telephone-Linked Care Diabetes Project): study protocol.

BACKGROUND: An estimated 285 million people worldwide have diabetes and its prevalence is predicted to increase to 439 million by 2030. For the year 2010, it is estimated that 3.96 million excess deaths in the age group 20-79 years are attributable to diabetes around the world. Self-management is recognised as an integral part of diabetes care. This paper describes the protocol of a randomised controlled trial of an automated interactive telephone system aiming to improve the uptake and maintenance of essential diabetes self-management behaviours. METHODS/DESIGN: A total of 340 individuals with type 2 diabetes will be randomised, either to the routine care arm, or to the intervention arm in which participants receive the Telephone-Linked Care (TLC) Diabetes program in addition to their routine care. The intervention requires the participants to telephone the TLC Diabetes phone system weekly for 6 months. They receive the study handbook and a glucose meter linked to a data uploading device. The TLC system consists of a computer with software designed to provide monitoring, tailored feedback and education on key aspects of diabetes self-management, based on answers voiced or entered during the current or previous conversations. Data collection is conducted at baseline (Time 1), 6-month follow-up (Time 2), and 12-month follow-up (Time 3). The primary outcomes are glycaemic control (HbA1c) and quality of life (Short Form-36 Health Survey version 2). Secondary outcomes include anthropometric measures, blood pressure, blood lipid profile, psychosocial measures as well as measures of diet, physical activity, blood glucose monitoring, foot care and medication taking. Information on utilisation of healthcare services including hospital admissions, medication use and costs is collected. An economic evaluation is also planned. DISCUSSION: Outcomes will provide evidence concerning the efficacy of a telephone-linked care intervention for self-management of diabetes. Furthermore, the study will provide insight into the potential for more widespread uptake of automated telehealth interventions, globally. TRIAL REGISTRATION NUMBER: ACTRN12607000594426.

User Experiences With a Type 2 Diabetes Coaching App: Qualitative Study.

BACKGROUND: Diabetes self-management apps have the potential to improve self-management in people with type 2 diabetes (T2D). Although efficacy trials provide evidence of health benefits, premature disengagement from apps is common. Therefore, it is important to understand the factors that influence engagement in real-world settings. OBJECTIVE: This study aims to explore users' real-world experiences with the My Diabetes Coach (MDC) self-management app. METHODS: We conducted telephone-based interviews with participants who had accessed the MDC self-management app via their smartphone for up to 12 months. Interviews focused on user characteristics; the context within which the app was used; barriers and facilitators of app use; and the design, content, and delivery of support within the app. RESULTS: A total of 19 adults with T2D (8/19, 42% women; mean age 60, SD 14 years) were interviewed. Of the 19 interviewees, 8 (42%) had T2D for <5 years, 42% (n=8) had T2D for 5-10 years, and 16% (n=3) had T2D for >10 years. In total, 2 themes were constructed from interview data: (1) the moderating effect of diabetes self-management styles on needs, preferences, and expectations and (2) factors influencing users' engagement with the app: one size does not fit all. CONCLUSIONS: User characteristics, the context of use, and features of the app interact and influence engagement. Promoting engagement is vital if diabetes self-management apps are to become a useful complement to clinical care in supporting optimal self-management. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry CTRN126140012296; URL https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366925&isReview=true.

Acceptability of an Embodied Conversational Agent for Type 2 Diabetes Self-Management Education and Support via a Smartphone App: Mixed Methods Study.

BACKGROUND: Embodied conversational agents (ECAs) are increasingly used in health care apps; however, their acceptability in type 2 diabetes (T2D) self-management apps has not yet been investigated. OBJECTIVE: This study aimed to evaluate the acceptability of the ECA (Laura) used to deliver diabetes self-management education and support in the My Diabetes Coach (MDC) app. METHODS: A sequential mixed methods design was applied. Adults with T2D allocated to the intervention arm of the MDC trial used the MDC app over a period of 12 months. At 6 months, they completed questions assessing their interaction with, and attitudes toward, the ECA. In-depth qualitative interviews were conducted with a subsample of the participants from the intervention arm to explore their experiences of using the ECA. The interview questions included the participants' perceptions of Laura, including their initial impression of her (and how this changed over time), her personality, and human character. The quantitative and qualitative data were interpreted using integrated synthesis. RESULTS: Of the 93 intervention participants, 44 (47%) were women; the mean (SD) age of the participants was 55 (SD 10) years and the baseline glycated hemoglobin A1c level was 7.3% (SD 1.5%). Overall, 66 of the 93 participants (71%) provided survey responses. Of these, most described Laura as being helpful (57/66, 86%), friendly (57/66, 86%), competent (56/66, 85%), trustworthy (48/66, 73%), and likable (40/66, 61%). Some described Laura as not real (18/66, 27%), boring (26/66, 39%), and annoying (20/66, 30%). Participants reported that interacting with Laura made them feel more motivated (29/66, 44%), comfortable (24/66, 36%), confident (14/66, 21%), happy (11/66, 17%), and hopeful (8/66, 12%). Furthermore, 20% (13/66) of the participants were frustrated by their interaction with Laura, and 17% (11/66) of the participants reported that interacting with Laura made them feel guilty. A total of 4 themes emerged from the qualitative data (N=19): (1) perceived role: a friendly coach rather than a health professional; (2) perceived support: emotional and motivational support; (3) embodiment preference acceptability of a human-like character; and (4) room for improvement: need for greater congruence between Laura's words and actions. CONCLUSIONS: These findings suggest that an ECA is an acceptable means to deliver T2D self-management education and support. A human-like character providing ongoing, friendly, nonjudgmental, emotional, and motivational support is well received. Nevertheless, the ECA can be improved by increasing congruence between its verbal and nonverbal communication and accommodating user preferences. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry CTRN12614001229662; https://tinyurl.com/yxshn6pd.

Rethinking Models of Outpatient Specialist Care in Type 2 Diabetes Using eHealth: Study Protocol for a Pilot Randomised Controlled Trial.

Conventional outpatient services are unlikely to meet burgeoning demand for diabetes services given increasing prevalence of diabetes, and resultant impact on the healthcare workforce and healthcare costs. Disruptive technologies (such as smartphone and wireless sensors) create an opportunity to redesign outpatient services. In collaboration, the Department of Diabetes and Endocrinology at Brisbane Princess Alexandra Hospital, the University of Queensland Centre for Health Services Research and the Australian e-Health Research Centre developed a mobile diabetes management system (MDMS) to support the management of complex outpatient type 2 diabetes mellitus (T2DM) adults. The system comprises of a mobile App, an automated text-messaging feedback and a clinician portal. Blood glucose levels (BGL) data are automatically transferred by Bluetooth-enabled glucose meter to the clinician portal via the mobile App. The primary aim of the study described here is to examine improvement in glycaemic control of a new model of care employing MDMS for patients with complex T2DM attending a tertiary level outpatient service. A two-group, 12-month, pilot pragmatic randomised control trial will recruit 44 T2DM patients. The control group will receive routine care. The intervention group will be supported by the MDMS enabling the participants to potentially better self-manage their diabetes, and the endocrinologists to remotely monitor BGL and to interact with patients through a variety of eHealth modalities. Intervention participants will be encouraged to complete relevant pathology tests, and report on current diabetes management through an online questionnaire. Using this information, the endocrinologist may choose to reschedule the appointment or substitute it with a telephone or video-consultation. This pilot study will guide the conduct of a large-scale study regarding the capacity for a new model of care. This model utilises multimodal eHealth strategies via the MDMS to primarily improve glycaemic control with secondary aims to improve patient experience, reduce reliance on physical clinics, and decrease service delivery cost.

Mobile-based insulin dose adjustment for type 2 diabetes in community and rural populations: study protocol for a pilot randomized controlled trial.

BACKGROUND: Insulin initiation and/or titration for type 2 diabetes (T2DM) is often delayed as it is a resource-intensive process, often requiring frequent exchange of information between a patient and their diabetes healthcare professional, such as a credentialed diabetes educator (CDE) for insulin dose adjustment (IDA). Existing models of IDA are unlikely to meet the increasing service demand unless efficiencies are increased. Mobile health (mHealth), a subset of Ehealth, has been shown to improve glycaemic control through enhanced self-management and feedback leading to improved patient satisfaction and could simultaneously reduce costs. Considering the potential benefits of mHealth, we have developed an innovative mHealth-based care model to support patients and clinicians in diabetes specialist community outreach and telehealth clinics, that is, REthinking Model of Outpatient Diabetes care utilizing EheaLth - Insulin Dose Adjustment (REMODEL-IDA). This model primarily aims to improve the glycaemic management of patients with T2DM on insulin, with the secondary aims of improving healthcare service delivery efficiency and the patients' experience. METHODS/DESIGN: A two-arm pilot randomized controlled trial (RCT) will be conducted for 3 months with 44 participants, randomized at a 1:1 ratio to receive either the mHealth-based model of care (intervention) or routine care (control), in diabetes specialist community outreach and telehealth clinics. The intervention arm will exchange information related to blood glucose levels via the Mobile Diabetes Management System developed for outpatients with T2DM. They will receive advice on insulin titration from the CDE via the mobile-app and receive automated text-message prompts for better self-management based on their blood glucose levels and frequency of blood glucose testing. The routine care arm will be followed up via telephone calls by the CDE as per usual practice. The primary outcome is change in glycated haemoglobin, a marker of glycaemic management, at 3 months. Patient and healthcare provider satisfaction, and time required to perform IDA by healthcare providers in both arms will be collected. This pilot study will guide the conduct of a large-scale pragmatic RCT in regional Australia.

Outcomes of a feasibility trial using an innovative mobile health programme to assist in insulin dose adjustment.

OBJECTIVE: Intensification of diabetes therapy with insulin is often delayed for people with suboptimal glycaemic control. This paper reports on the feasibility of using an innovative mobile health (mHealth) programme to assist a diabetes insulin dose adjustment (IDA) service. METHODS: Twenty adults with diabetes referred to a tertiary hospital IDA service were recruited. They were provided with a cloud-based mobile remote monitoring system-the mobile diabetes management system (MDMS). The credentialled diabetes educator (CDE) recorded the time taken to perform IDA utilising the MDMS versus the conventional method-which is a weekly adjustment of insulin doses by a CDE through telephone contact based on three or more daily blood glucose readings. Participants and staff completed a feedback questionnaire. RESULTS: The CDE spent 55% less time performing IDA using MDMS than using the conventional method. The participants were satisfied with MDMS use and the CDEs reported improved efficiency. CONCLUSION: Incorporating a mHealth programme for an IDA service has the potential to improve service delivery efficiencies while simultaneously improving the patient experience.

A comparison of characteristics of patients seen in a tertiary hospital diabetes telehealth service versus specialist face-to-face outpatients.

This study aimed to describe patient-related characteristics of those attending the diabetes telehealth service delivered from a tertiary hospital and compare these with the characteristics of patients attending face-to-face visits at the same hospital's diabetes outpatient service. This analysis could inform diabetes telehealth service improvements. To our knowledge, there has been no prior evaluation of a diabetes telehealth service in Australia. A cross-sectional survey was conducted as part of the Australian National Diabetes Audit in May 2016 for all patients attending the diabetes telehealth service and diabetes outpatient service. The diabetes telehealth service was serving a greater proportion of females, indigenous people and patients with a longer mean duration of type 2 diabetes mellitus. Type 2 diabetes mellitus patients in the diabetes telehealth service group had a higher average glycated haemoglobin of 9.1% (76 mmol/mol) vs 8.1% (65 mmol/mol) in the diabetes outpatient service group. The diabetes telehealth service had more people with initial visits; had higher self-reported smoking rates in type 2 diabetes mellitus patients; and had adequate access to allied health supports as recommended for diabetes management. Diabetes telehealth service patients had more complex diabetes as evidenced by a higher proportion of indigenous clients, higher glycated haemoglobin and longer mean duration of diabetes.

Telehealth for chronic disease management: do we need to RE-AIM?

An increasing number of individuals are living with long term health conditions which they manage most of the time by themselves. This paper evaluates the use of information and communications technology platforms to provide evidence-based programs to help people with chronic disease to self-management these. It describes two different self-management strategies for chronic conditions, and the evaluation of their implementation in clinical trials, specifically in terms of reach, implementation fidelity, adoption and user perceptions. It also discusses the challenges in replicating trial findings in the real world, using the RE-AIM framework.