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Background: Digital interventions offer a potentially cost-effective means to support patient self-management in primary care, but evidence for the feasibility, acceptability and cost-effectiveness of digital interventions remains mixed. This programme focused on the potential for self-management digital interventions to improve outcomes in two common, contrasting conditions (i.e. hypertension and asthma) for which care is currently suboptimal, leading to excess deaths, illness, disability and costs for the NHS. Objectives: The overall purpose was to address the question of how digital interventions can best provide cost-effective support for patient self-management in primary care. Our aims were to develop and trial digital interventions to support patient self-management of hypertension and asthma. Through the process of planning, developing and evaluating these interventions, we also aimed to generate a better understanding of what features and methods for implementing digital interventions could make digital interventions acceptable, feasible, effective and cost-effective to integrate into primary care. Design: For the hypertension strand, we carried out systematic reviews of quantitative and qualitative evidence, intervention planning, development and optimisation, and an unmasked randomised controlled trial comparing digital intervention with usual care, with a health economic analysis and nested process evaluation. For the asthma strand, we carried out a systematic review of quantitative evidence, intervention planning, development and optimisation, and a feasibility randomised controlled trial comparing digital intervention with usual care, with nested process evaluation. Setting: General practices (hypertension, n = 76; asthma, n = 7) across Wessex and Thames Valley regions in Southern England. Participants: For the hypertension strand, people with uncontrolled hypertension taking one, two or three antihypertensive medications. For the asthma strand, adults with asthma and impaired asthma-related quality of life. Interventions: Our hypertension intervention (i.e. HOME BP) was a digital intervention that included motivational training for patients to self-monitor blood pressure, as well as health-care professionals to support self-management; a digital interface to send monthly readings to the health-care professional and to prompt planned medication changes when patients’ readings exceeded recommended targets for 2 consecutive months; and support for optional patient healthy behaviour change (e.g. healthy diet/weight loss, increased physical activity and reduced alcohol and salt consumption). The control group were provided with a Blood Pressure UK (London, UK) leaflet for hypertension and received routine hypertension care. Our asthma intervention (i.e. My Breathing Matters) was a digital intervention to improve the functional quality of life of primary care patients with asthma by supporting illness self-management. Motivational content intended to facilitate use of pharmacological self-management strategies (e.g. medication adherence and appropriate health-care service use) and non-pharmacological self-management strategies (e.g. breathing retraining, stress reduction and healthy behaviour change). The control group were given an Asthma UK (London, UK) information booklet on asthma self-management and received routine asthma care. Main outcome measures: The primary outcome for the hypertension randomised controlled trial was difference between intervention and usual-care groups in mean systolic blood pressure (mmHg) at 12 months, adjusted for baseline blood pressure, blood pressure target (i.e. standard, diabetic or aged > 80 years), age and general practice. The primary outcome for the asthma feasibility study was the feasibility of the trial design, including recruitment, adherence, intervention engagement and retention at follow-up. Health-care utilisation data were collected via notes review. Review methods: The quantitative reviews included a meta-analysis. The qualitative review comprised a meta-ethnography. Results: A total of 622 hypertensive patients were recruited to the randomised controlled trial, and 552 (89%) were followed up at 12 months. Systolic blood pressure was significantly lower in the intervention group at 12 months, with a difference of –3.4 mmHg (95% confidence interval –6.1 to –0.8 mmHg), and this gave an incremental cost per unit of systolic blood pressure reduction of £11 (95% confidence interval £5 to £29). Owing to a cost difference of £402 and a quality-adjusted life-year (QALY) difference of 0.044, long-term modelling puts the incremental cost per QALY at just over £9000. The probability of being cost-effective was 66% at willingness to pay £20,000 per quality-adjusted life-year, and this was higher at higher thresholds. A total of 88 patients were recruited to the asthma feasibility trial (target n = 80; n = 44 in each arm). At 3-month follow-up, two patients withdrew and six patients did not complete outcome measures. At 12 months, two patients withdrew and four patients did not complete outcome measures. A total of 36 out of 44 patients in the intervention group engaged with My Breathing Matters [with a median of four (range 0–25) logins]. Limitations: Although the interventions were designed to be as accessible as was feasible, most trial participants were white and participants of lower socioeconomic status were less likely to take part and complete follow-up measures. Challenges remain in terms of integrating digital interventions with clinical records. Conclusions: A digital intervention using self-monitored blood pressure to inform medication titration led to significantly lower blood pressure in participants than usual care. The observed reduction in blood pressure would be expected to lead to a reduction of 10–15% in patients suffering a stroke. The feasibility trial of My Breathing Matters suggests that a fully powered randomised controlled trial of the intervention is warranted. The theory-, evidence-and person-based approaches to intervention development refined through this programme enabled us to identify and address important contextual barriers to and facilitators of engagement with the interventions. Future work: This research justifies consideration of further implementation of the hypertension intervention, a fully powered randomised controlled trial of the asthma intervention and wide dissemination of our methods for intervention development. Our interventions can also be adapted for a range of other health conditions. Trial and study registration: The trials are registered as ISRCTN13790648 (hypertension) and ISRCTN15698435 (asthma). The studies are registered as PROSPERO CRD42013004773 (hypertension review) and PROSPERO CRD42014013455 (asthma review).

BACKGROUND:Cochlear implants provide hearing to around 750,000 people with deafness worldwide; patients require lifelong follow-up. Care for adults with implants in the UK occurs at one of 19 centres, which may be far from the patient's home. In a previous RCT, we successfully introduced person-centred care. We designed, implemented and evaluated a remote care pathway: a personalised online support tool, home hearing check, self device adjustment, and upgrading of sound processors at home rather than in clinic. The remote care group had a significant increase in empowerment after using the tools; patients and clinicians were keen to continue. We would now like to scale up these improvements as an option to the more than 12,000 UK adults using implants; we are commissioning an independent evaluation of this intervention and roll out to establish if it achieves its aims of more empowered and confident patients; more accessible and equitable care; stable hearing; more efficient, person-centred and scalable service; more satisfied and engaged patients and clinicians.OBJECTIVE:To evaluate the impact and roll out of a person-centred clinical care pathway via telemedicine for adults with cochlear implants in the UK, using both outcomes and process evaluation.METHODS:This project will scale up and evaluate a person-centred long-term follow-up pathway for adults using cochlear implants using a personalised website including a home hearing check, upload of photos of cochlear implant site, listening in noise and music practice, spares ordering, questionnaires, and other resources. Both quantitative and qualitative analyses will occur, and it will be both an outcomes and process evaluation.RESULTS:As of July 2021, the trial is closed, and all data collection is complete. The evaluation report is expected to be published in December 2021; the research data have not been analysed yet.CONCLUSIONS:This project will present results of the first scaling up of a remote care pathway for adults with cochlear implants in the UK.

Purpose: The purpose of this study is to comprehensively describe the intervention planning process for the Tinnitus E-Programme 2.0, an Internet-based cognitive behavioral intervention for tinnitus. Method: Theory-, evidence-, and person-based approaches to intervention development were used. In Phase 1, quantitative systematic reviews were used to identify potentially effective intervention techniques and design features. Primary mixed-methods research involving adults with tinnitus explored the acceptability of the first version of the intervention. In Phase 2, person-based guiding principles highlighted key intervention design objectives and features to address needs of the intervention’s target group (identified in Phase 1) to maximize its acceptability, feasibility of delivery, and effectiveness. Theory-based “behavioral analysis” and “logic modeling” comprehensively described intervention content and potential mechanisms of action. From this planning work, a prototype intervention was developed. Results: The intervention design objectives outlined in the guiding principles were to (a) normalize tinnitus, (b) support users to maintain a regular relaxation practice, (c) minimize the worsening of users’ tinnitus sensation, and (d) ensure the intervention is accessible to those with hearing loss. Behavioral analysis and logic modeling identified intervention processes (e.g., illness perceptions, beliefs about consequences, skills, goals) and purported mediators (acceptance of tinnitus, negative thinking, use of the cognitive skills tools for managing negative thoughts, and practicing regular relaxation) hypothesized to facilitate reductions in tinnitus symptom severity. Conclusions: The guiding principles highlight key design objectives and features to consider when developing interventions for tinnitus. The logic model offers hypothesized mechanisms of action that can be tested in future process analyses.

© 2020 The Authors. British Journal of Health Psychology published by John Wiley & Sons Ltd on behalf of British Psychological Society Objectives: To explore users’ reactions to and expectations of the Tinnitus E-Programme 2.0, a digital cognitive behavioural intervention for tinnitus, and to identify contextual factors and mechanisms of action that may influence user engagement with the intervention. Design: Qualitative interview study. Methods: Think-aloud and semi-structured interviews were carried out with 19 people with tinnitus. Interviews explored participants’ views of the intervention’s information and advice, its wider intervention goals (e.g. behaviour change, self-management), and factors that may strengthen or impede users’ engagement. Data were analysed using inductive thematic analysis, and findings were used to develop a conceptual model of user engagement with the intervention. Results: Generally, participants expressed positive views of the intervention, its intervention components, and its design features. Identified contextual factors included pre-existing attitudes, beliefs, skills, and knowledge (e.g. perceptions of tinnitus symptom severity, openness to tinnitus management, and psychological techniques); previous experience of tinnitus management; and characteristics of the condition (e.g. heterogeneous nature of tinnitus, stage in healthcare journey). These contextual factors were hypothesized to influence engagement through four mechanisms of action: motivation to change tinnitus-related attitudes and behaviour; perceived personal relevance of the intervention; expectations of benefit; and appeal of the intervention techniques. Conclusions: This study demonstrated the acceptability of the Tinnitus E-Programme 2.0 amongst its target group, while highlighting potential areas for improvement in future intervention modifications. Our findings identified contextual factors that others developing interventions for tinnitus or cognitive behavioural interventions may wish to consider.

Background: Tinnitus is a common medical symptom that can affect an individual’s emotional and functional quality of life. Psychological therapies are acknowledged as beneficial to people with tinnitus, however, they are not always readily accessible. With their global reach, internet-based interventions have the potential to reduce the disparity in access to psychological support which people with tinnitus currently experience. Aim: This research will explore users’ reactions to and interactions with the Tinnitus E-Programme, an internet-based intervention for the self-management of tinnitus that is currently available online. Methods: Ten people with tinnitus have completed the programme and taken part in a semi-structured interview to date. Participants also completed a relaxation log to explore how well they were able to implement the skills they learnt during the programme in their everyday lives. The interview data will be presented. Results: Thematic analysis revealed that, overall, the programme was highly acceptable to its target population. Users valued the provided education about tinnitus and its management, relaxation skills training and cognitive restructuring training. Usage of the tools to self-monitor levels of tinnitus distress was variable and few people reported joining or participating in the online support group. Participants appreciated being able to work flexibly with the programme and engaging with the materials ‘offline’. Usability issues meant that some essential programme components were often missed. Conclusions: Findings suggest that the programme offers an acceptable form of tinnitus management for its target group. However, this work also highlighted some key opportunities to improve the programme. In future work, these qualitative findings will be triangulated with the relaxation log data and the findings from a parallel online survey with past users who have used the programme in the real-world. Consistent with a person-based approach, this research will inform the development of a set of guiding principles for future optimisation work.