Implementing a text message-based intervention to support type 2 diabetes medication adherence in primary care: a qualitative study with general practice staff.

BACKGROUND: The Support through Mobile Messaging and digital health Technology for Diabetes (SuMMiT-D) project has developed, and is evaluating, a mobile phone-based intervention delivering brief messages targeting identified behaviour change techniques promoting medication use to people with type 2 diabetes in general practice. The present study aimed to inform refinement and future implementation of the SuMMiT-D intervention by investigating general practice staff perceptions of how a text message-based intervention to support medication adherence should be implemented within current and future diabetes care. METHODS: Seven focus groups and five interviews were conducted with 46 general practice staff (including GPs, nurses, healthcare assistants, receptionists and linked pharmacists) with a potential role in the implementation of a text message-based intervention for people with type 2 diabetes. Interviews and focus groups were audio-recorded, transcribed and analysed using an inductive thematic analysis approach. RESULTS: Five themes were developed. One theme 'The potential of technology as a patient ally' described a need for diabetes support and the potential of technology to support medication use. Two themes outlined challenges to implementation, 'Limited resources and assigning responsibility' and 'Treating the patient; more than diabetes medication adherence'. The final two themes described recommendations to support implementation, 'Selling the intervention: what do general practice staff need to see?' and 'Fitting the mould; complementing current service delivery'. CONCLUSIONS: Staff see the potential for a text message-based support intervention to address unmet needs and to enhance care for people with diabetes. Digital interventions, such as SuMMiT-D, need to be compatible with existing systems, demonstrate measurable benefits, be incentivised and be quick and easy for staff to engage with. Interventions also need to be perceived to address general practice priorities, such as taking a holistic approach to care and having multi-cultural reach and relevance. Findings from this study are being combined with parallel work with people with type 2 diabetes to ensure stakeholder views inform further refinement and implementation of the SuMMiT-D intervention.

Understanding acceptability in the context of text messages to encourage medication adherence in people with type 2 diabetes.

BACKGROUND: Acceptability is recognised as a key concept in the development of health interventions, but there has been a lack of consensus about how acceptability should be conceptualised. The theoretical framework of acceptability (TFA) provides a potential tool for understanding acceptability. It has been proposed that acceptability measured before use of an intervention (anticipated acceptability) may differ from measures taken during and after use (experienced acceptability), but thus far this distinction has not been tested for a specific intervention. This paper 1) directly compares ratings of anticipated and experienced acceptability of a text message-based intervention, 2) explores the applicability of the TFA in a technology-based intervention, and 3) uses these findings to inform suggestions for measuring acceptability over the lifespan of technology-based health interventions. METHODS: Data were obtained from a quantitative online survey assessing anticipated acceptability of the proposed text messages (n = 59) and a 12-week proof-of-concept mixed methods study assessing experienced acceptability while receiving the text messages (n = 48). Both quantitative ratings by return text message, and qualitative data from participant interviews were collected during the proof-of-concept study. RESULTS: The quantitative analysis showed anticipated and experienced acceptability were significantly positively correlated (rs > .4). The qualitative analysis identified four of the seven constructs of the TFA as themes (burden, intervention coherence, affective attitude and perceived effectiveness). An additional two themes were identified as having an important impact on the TFA constructs (perceptions of appropriateness and participants' role). Three suggestions are given related to the importance of appropriateness, what may affect ratings of acceptability and what to consider when measuring acceptability. CONCLUSIONS: The high correlation between anticipated and experienced acceptability was a surprising finding and could indicate that, in some cases, acceptability of an intervention can be gauged adequately from an anticipated acceptability study, prior to an expensive pilot or feasibility study. Directly exploring perceptions of appropriateness and understanding whether the acceptability described by participants is related to the intervention or the research - and is for themselves or others - is important in interpreting the results and using them to further develop interventions and predict future use.

A novel experience-based internet intervention for smoking cessation: feasibility randomised controlled trial.

BACKGROUND: The internet is frequently used to share experiences of health and illness, but this phenomenon has not been harnessed as an intervention to achieve health behaviour change. The aim of this study was to determine the feasibility of a randomised trial assessing the effects of a novel, experience-based website as a smoking cessation intervention. The secondary aim was to measure the potential impact on smoking behaviour of both the intervention and a comparator website. METHODS: A feasibility randomised controlled single-blind trial assessed a novel, experience-based website containing personal accounts of quitting smoking as a cessation intervention, and a comparator website providing factual information. Feasibility measures including recruitment, and usage of the interventions were recorded, and the following participant-reported outcomes were also measured: Smoking Abstinence Self-Efficacy Questionnaire, the single-item Motivation to Stop Scale, self-reported abstinence, quit attempts and health status outcomes. Eligible smokers from two English regions were entered into the trial and given access to their allocated website for two weeks. RESULTS: Eighty-seven smokers were randomised, 65 completed follow-up (75 %). Median usage was 15 min for the intervention, and 5 min for the comparator (range 0.5-213 min). Median logins for both sites was 2 (range 1-20). All participant-reported outcomes were similar between groups. CONCLUSIONS: It was technically feasible to deliver a novel intervention harnessing the online sharing of personal experiences as a tool for smoking cessation, but recruitment was slow and actual use was relatively low, with attrition from the trial. Future work needs to maximize engagement and to understand how best to assess the value of such interventions in everyday use, rather than as an isolated 'dose of information'. TRIAL REGISTRATION: ISRCTN29549695 DOI 10.1186/ISRCTN29549695 . Registered 17/05/2013.

Patient use of email for health care communication purposes across 14 European countries: an analysis of users according to demographic and health-related factors.

BACKGROUND: The use of the Internet for health purposes is growing steadily, yet the use of asynchronous communication tools for health care purposes remains undeveloped. The introduction of email as a method of communication in health care has the potential to impact on both patients and health care professionals. OBJECTIVE: This study aims to describe the characteristics of people who have sent or received an email to or from their doctor, nurse, or health care organization, by country and in relation to demographics, health care resource use, and health status factors. METHODS: We conducted a secondary analysis of data (N=14,000) collected from the online Citizens and Information Communication Technology for Health survey, a project undertaken in 2011 by the Institute for Prospective Technology Studies of the European Commission's Joint Research Centre. The survey was developed to understand and characterize European citizens' use of information communication technologies for health. Descriptive and statistical analyses of association were used to interpret the data. RESULTS: Denmark reported the highest level of emails sent/received (507/1000, 50.70%). The lowest level reported was by participants in France (187/1000, 18.70%). Men used email communication for health care more than women, as did respondents in the 16-24 age group and those educated to tertiary level or still within the education system. As self-reported health state worsens, the proportion of people reporting having sent or received an email within the context of health care increases. Email use, poor health, multimorbidity, and number of visits to a physician are positively correlated. CONCLUSIONS: The use of email communication within the context of European health care is extremely varied. The relationship between high email use, poor health, doctor visits, and multimorbidity is especially pertinent: provision of asynchronous communication for such groups is favored by policymakers. Low reported email use by country may not necessarily reflect low interest in using email for health care: local health policies and technical infrastructures may be significant factors in the delay in implementation of alternative forms of routine health communication.

Effects of Using a Text Message Intervention on Psychological Constructs and the Association Between Changes to Psychological Constructs and Medication Adherence in People With Type 2 Diabetes: Results From a Randomized Controlled Feasibility Study.

BACKGROUND: Poor adherence to oral medications is common in people with type 2 diabetes and can lead to an increased chance of health complications. Text messages may provide an effective delivery method for an intervention; however, thus far, the majority of these interventions do not specify either a theoretical basis or propose specific mechanisms of action. This makes it hard to determine how and whether an intervention is having an effect. The text messages included in the current intervention have been developed to deliver specific behavior change techniques. These techniques are the "active ingredients" of the intervention and were selected to target psychological constructs identified as predictors of medication adherence. OBJECTIVE: There are 2 aims of this study: (1) to assess whether a text message intervention with specified behavior change techniques can change the constructs that predict medication adherence behaviors in people with type 2 diabetes and (2) to assess whether changes to psychological constructs are associated with changes in self-reported medication adherence. METHODS: We conducted a randomized controlled, 6-month feasibility trial. Adults prescribed oral medication for type 2 diabetes (N=209) were recruited from general practice and randomized to either receive a text message-based intervention or care as usual. Data were analyzed with repeated measures analysis of covariance and Spearman rho correlation coefficients. RESULTS: For 8 of the 14 constructs that were measured, a significant time-by-condition interaction was found: necessity beliefs, intention, maintenance self-efficacy, recovery self-efficacy, action control, prompts and cues, social support, and satisfaction with experienced consequences all increased in the intervention group compared to the control group. Changes in action self-efficacy, intention, automaticity, maintenance self-efficacy, and satisfaction with experienced consequences were positively associated with changes in self-reported medication adherence. CONCLUSIONS: A relatively low-cost, scalable, text message-only intervention targeting medication adherence using behavior change techniques can influence psychological constructs that predict adherence. Not only do these constructs predict self-reported medication adherence, but changes in these constructs are correlated with changes in self-reported medication adherence. These findings support the promise of text message-based interventions for medication adherence in this population and suggest likely mechanisms of action. TRIAL REGISTRATION: ISRCTN Registry ISRCTN13404264; https://www.isrctn.com/ISRCTN13404264.

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.

Supporting People With Type 2 Diabetes in the Effective Use of Their Medicine Through Mobile Health Technology Integrated With Clinical Care to Reduce Cardiovascular Risk: Protocol for an Effectiveness and Cost-effectiveness Randomized Controlled Trial.

BACKGROUND: Type 2 diabetes is a common lifelong condition that affects over 400 million people worldwide. The use of effective medications and active self-management can reduce the risk of serious complications. However, people often have concerns when starting new medications and face difficulties in taking their medications regularly. Support provided by brief messages delivered through mobile phone-based SMS text messages can be effective in some long-term conditions. We have identified promising behavior change techniques (BCTs) to promote medication adherence in this population via a systematic review and developed SMS text messages that target these BCTs. Feasibility work has shown that these messages have fidelity to intended BCTs, are acceptable to patients, and are successful in changing the intended determinants of medication adherence. We now plan to test this intervention on a larger scale in a clinical trial. OBJECTIVE: The aim of this trial is to determine the effectiveness and cost-effectiveness of this intervention for reducing cardiovascular risk in people with type 2 diabetes by comparing it with usual care. METHODS: The trial will be a 12-month, multicenter, individually randomized controlled trial in primary care and will recruit adults (aged ≥35 years) with type 2 diabetes in England. Consenting participants will be randomized to receive short SMS text messages intended to affect a change in medication adherence 3 to 4 times per week in addition to usual care. The aim is to test the effectiveness and cost-effectiveness of the intervention when it is added to usual care. The primary clinical outcome will be a composite cardiovascular risk measure. Data including patient-reported measures will be collected at baseline, at 13 and 26 weeks, and at the end of the 12-month follow-up period. With 958 participants (479 in each group), the trial is powered at 92.5% to detect a 4-percentage point difference in cardiovascular risk. The analysis will follow a prespecified plan. A nested quantitative and qualitative process analysis will be used to examine the putative mechanisms of behavior change and wider contextual influences. A health economic analysis will be used to assess the cost-effectiveness of the intervention. RESULTS: The trial has completed the recruitment phase and is in the follow-up phase. The publication of results is anticipated in 2024. CONCLUSIONS: This trial will provide evidence regarding the effectiveness and cost-effectiveness of this intervention for people with type 2 diabetes. TRIAL REGISTRATION: ISRCTN Registry ISRCTN15952379; https://www.isrctn.com/ISRCTN15952379. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/32918.

Recruiting patients to a digital self-management study whilst in hospital for a chronic obstructive pulmonary disease exacerbation: A feasibility analysis.

BACKGROUND: Patients with chronic obstructive pulmonary disease (COPD) are often hospitalised with acute exacerbations (AECOPD) and many patients get readmitted. Intervening with hospitalised patients may be optimal timing to provide support. Our previous work demonstrated use of a digital monitoring and self-management support tool in the community. However, we wanted to explore the feasibility of recruiting patients whilst hospitalised for an AECOPD, and to identify the rate of dropout attrition around admission for AECOPD. METHODS: Patients were recruited to the EDGE2 study between May 2019 and March 2020. Patients were identified by the clinical teams and patients were recruited by members of the clinical research team. Participants were aged 40 years or older, had a diagnosis of COPD and were attending or admitted to hospital for an AECOPD. Participants were given a tablet computer, Bluetooth-linked pulse oximeter and wrist-worn physical activity monitor to use until 6 months post-discharge. Use of the system aimed to support COPD self-management by enabling self-monitoring of vital signs, COPD symptoms, mood and physical activity, and access to multi-media educational resources. RESULTS: 281 patients were identified and 126 approached. The main referral source was the specialist respiratory nursing and physiotherapist team (49.8% of patients identified). Twenty-six (37.1%) patients were recruited. As of 21 April 2020, 14 (53.8%) participants withdrew and 11 (of 14; 78.6%) participants withdrew within four weeks of discharge. The remaining participants withdrew between one and three months follow-up (1 of 14; 7.1%) and between three and six months follow-up (2 of 14; 14.3%). CONCLUSION: A large number of patients were screened to recruit a relatively small sample and a high rate of dropout was observed. It does not appear feasible to recruit patients with COPD to digital interventional studies from the hospital setting when they have the burden of coping with acute illness.

British South Asian Patients' Perspectives on the Relevance and Acceptability of Mobile Health Text Messaging to Support Medication Adherence for Type 2 Diabetes: Qualitative Study.

BACKGROUND: The prevalence of type 2 diabetes (T2D) is greater in South Asian populations and health outcomes are poorer compared with other ethnic groups. British South Asians are up to six times more likely to have T2D than the general population, to develop the condition at a younger age, and to experience diabetes-related complications. Interventions to support people in managing their condition can potentially reduce debilitating complications. Evidence to support the use of digital devices in T2D management, including mobile phones, has shown positive impacts on glycemic control. There is increasing recognition that health interventions that are culturally adapted to the needs of specific groups are more likely to be relevant and acceptable, but evidence to support the effectiveness of adapted interventions is limited and inconclusive. OBJECTIVE: This formative study aimed to explore the perceptions and views of British South Asian patients with T2D on mobile health SMS text messaging to support medication adherence, aimed at the general UK population. METHODS: Eight exploratory focus groups were conducted in Leicester, the United Kingdom, between September 2017 and March 2018. A diverse sample of 67 adults took part. RESULTS: British South Asian people with T2D who use digital devices, including mobile phones, felt that short messages to support medication adherence would be acceptable and relevant, but they also wanted messages that would support other aspects of self-management too. Participants were particularly interested in content that met their information needs, including information about South Asian foods, commonly used herbs and spices, natural and herbal approaches used in the United Kingdom and in South Asia, and religious fasting. Short messages delivered in English were perceived to be acceptable, often because family members could translate for those unable to read or understand the messages. Suggestions to support patients unable to understand short messages in English included having them available in different formats, and disseminated in face-to-face groups for those who did not use digital devices. CONCLUSIONS: Exploring the views of British South Asian patients about SMS text messaging aimed at the general UK population is important in maximizing the potential of such an intervention. For such a digital system to meet the needs of UK South Asian populations, it may also have to include culturally relevant messages sent to those who opt to receive them. It is equally important to consider how to disseminate message content to patients who do not use digital devices to help reduce health inequalities.

What do people with type 2 diabetes want from a brief messaging system to support medication adherence?

BACKGROUND: Many people with type 2 diabetes do not take their treatment as prescribed. Brief messages to support medication use could reach large numbers of people at a very low cost per person, but current interventions using brief messages rarely adequately describe the content of the messages, nor base these messages on explicit behavior change principles. This study reports the views of people with type 2 diabetes concerning the acceptability of 1) a messaging system and 2) proposed messages based on behavior change techniques (BCTs) and beliefs and concerns around taking medication. METHODS: The proposed system and brief messages were discussed in focus groups of people with type 2 diabetes recruited through general practices in England. Transcripts were analyzed thematically. PARTICIPANTS: Twenty-three participants took part in one of five focus group discussions. All participants were over 18 years, were taking tablet medication for their diabetes, and had access to a mobile phone. Key exclusion criteria were recent hospitalization for hyper- or hypoglycemia or diagnosis with a terminal illness. RESULTS: Four themes were identified as relating to the acceptability of the messaging system: "opportunities and limitations of technology", "us and them (who is the system for?)", "responsibility for adherence", and "diabetes management beyond medication". Participants recognized the benefit of using technology. Those with high confidence in their ability to adhere were keen to make a distinction between themselves and those who did not adhere; participants were more comfortable taking responsibility for medication than diet and exercise. Acceptability of the messages hinged on avoiding "preaching to the converted". CONCLUSIONS: These findings show that brief messaging could be acceptable to the target population for a range of diabetes-related behaviors but highlight the need for such a system to be perceived as personally relevant. Acceptable messages would need to maintain novelty for the target population.

Supporting people with type 2 diabetes in effective use of their medicine through mobile health technology integrated with clinical care (SuMMiT-D Feasibility): a randomised feasibility trial protocol.

INTRODUCTION: Type 2 diabetes is common, affecting over 400 million people worldwide. Risk of serious complications can be reduced through use of effective treatments and active self-management. However, people are often concerned about starting new medicines and face difficulties in taking them regularly. Use of brief messages to provide education and support self-management, delivered through mobile phone-based text messages, can be an effective tool for some long-term conditions. We have developed messages aiming to support patients' self-management of type 2 diabetes in the use of medications and other aspects of self-management, underpinned by theory and evidence. The aim of this trial is to determine the feasibility of a large-scale clinical trial to test the effectiveness and cost-effectiveness of the intervention, compared with usual care. METHODS AND ANALYSIS: The feasibility trial will be a multicentre individually randomised, controlled trial in primary care recruiting adults (≥35 years) with type 2 diabetes in England. Consenting participants will be randomised to receive short text messages three times a week with messages designed to produce change in medication adherence or non-health-related messages for 6 months. The aims are to test recruitment methods, retention to the study, the feasibility of data collection and the mobile phone and web-based processes of a proposed definitive trial and to refine the text messaging intervention. The primary outcome is the rate of recruitment to randomisation of participants to the trial. Data, including patient reported measures, will be collected online at baseline and the end of the 6-month follow-up period. With 200 participants (100 in each group), this trial is powered to estimate 80% follow-up within 95% CIs of 73.8% to 85.3%. The analysis will follow a prespecified plan. ETHICS AND DISSEMINATION: Ethics approval was obtained from the West of Scotland Research Ethics Committee 05. The results will be disseminated through conference presentations, peer-reviewed journals and will be published on the trial website: www.summit-d.org (SuMMiT-D (SUpport through Mobile Messaging and digital health Technology for Diabetes)). TRIAL REGISTRATION NUMBER: ISRCTN13404264.

Seven lessons for interdisciplinary research on interactive digital health interventions.

Research and development for interactive digital health interventions requires multi-disciplinary expertise in identifying user needs, and developing and evaluating each intervention. Two of the central areas of expertise required are Health (broadly defined) and Human-Computer Interaction. Although these share some research methods and values, they traditionally have deep differences that can catch people unawares, and make interdisciplinary collaborations challenging, resulting in sub-optimal project outcomes. The most widely discussed is the contrast between formative evaluation (emphasised in Human-Computer Interaction) and summative evaluation (emphasised in Health research). However, the differences extend well beyond this, from the nature of accepted evidence to the culture of reporting. In this paper, we present and discuss seven lessons that we have learned about the contrasting cultures, values, assumptions and practices of Health and Human-Computer Interaction. The lessons are structured according to a research lifecycle, from establishing the state of the art for a given digital intervention, moving through the various (iterative) stages of development, evaluation and deployment, through to reporting research results. Although our focus is on enabling people from different disciplinary backgrounds to work together with better mutual understanding, we also highlight ways in which future research in this interdisciplinary space could be better supported.

Randomised feasibility study of a novel experience-based internet intervention to support self-management in chronic asthma.

OBJECTIVE: To determine the feasibility of a randomised controlled trial (RCT) assessing the effects of an experience-based website as a resource for the self-management of chronic asthma. DESIGN AND SETTING: Feasibility, single-blind RCT in 2 regions of England. Randomisation used computer-generated random number sequence in a 1:1 ratio, after baseline data collection, to website access for 2 weeks. PARTICIPANTS: Adults (age ≥18 years), with clinically diagnosed asthma as coded in their primary care electronic record, prescribed inhaled corticosteroids for at least 3 months in the previous year, were recruited from 9 general practices. INTERVENTION: The EXPERT asthma intervention is an interactive PC/laptop/tablet/smartphone compatible website designed with extensive input from adults with asthma. It provides experience-based information and aims to support subjective perception of self-efficacy, self-management and improve health status. OUTCOME MEASURES: Primary outcomes were consent/recruitment, website usage and completion of outcome measures. Secondary outcomes included Partners in Health (PIH) questionnaire, the Chronic Disease Self-Efficacy Scale, the SF36 and the E-Health Impact Questionnaire. Participant blinding postrandomisation was not possible. The analysis was blind to allocation. RESULTS: Recruitment target exceeded. 148 participants randomised (73 intervention group). Age range 19-84 years; 59% female. 121 of 148 (84%; 62 intervention group) followed up. The median number of logins was 2 (IQR 2-3, range 1-48). Minimal differences of change from baseline between groups; both showed improvement in health state or management of their condition with no significant differences between arms. No adverse events. CONCLUSIONS: Recruitment and retention confirmed feasibility. The trends towards improved outcomes suggest that further research on digital interventions based on exposure to others' personal experiences may be of value in the self-management of chronic asthma. TRIAL REGISTRATION NUMBER: ISRCTN29549695; Results.