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.

Barriers and facilitators in accessing dementia care by ethnic minority groups: a meta-synthesis of qualitative studies.

BACKGROUND: It is estimated that there are about 25,000 people from UK ethnic minority groups with dementia. It is clear that there is an increasing need to improve access to dementia services for all ethnic groups to ensure that everyone has access to the same potential health benefits. The aim was to systematically review qualitative studies and to perform a meta-synthesis around barriers and facilitators to accessing care for dementia in ethnic minorities. METHODS: Databases were searched to capture studies on barriers and facilitators to accessing care for dementia in ethnic minorities. Analysis followed the guidelines for meta-ethnography. All interpretations of data as presented by the authors of the included papers were extracted and grouped into new themes. RESULTS: Six hundred and eighty four papers were identified and screened. Twenty eight studies were included in the meta-synthesis. The analysis developed a number of themes and these were incorporated into two overarching themes: 'inadequacies' and 'cultural habitus'. CONCLUSIONS: The two overarching themes lend themselves to interventions at a service level and a community level which need to happen in synergy. TRIAL REGISTRATION: The review was registered with PROSPERO: CRD42016049326 .

Does patient experience of multimorbidity predict self-management and health outcomes in a prospective study in primary care?

BACKGROUND: There is a need to better understand the mechanisms which lead to poor outcomes in patients with multimorbidity, especially those factors that might be amenable to intervention. OBJECTIVE: This research aims to explore what factors predict self-management behaviour and health outcomes in patients with multimorbidity in primary care in the UK. METHODS: A prospective study design was used. Questionnaires were mailed out to 1460 patients with multimorbidity. Patients were asked to complete a range of self-report measures including measures of multimorbidity, measures of their experience of multimorbidity and service delivery and outcomes (three measures of self-management: behaviours, Self-monitoring and Insight and medication adherence; and a measure of self-reported health). RESULTS: In total, 36% (n = 499) of patients responded to the baseline survey and 80% of those respondents completed follow-up. Self-management behaviour at 4 months was predicted by illness perceptions around the consequences of individual conditions. Self-monitoring and Insight at 4 months was predicted by patient experience of 'Hassles' in health services. Self-reported medication adherence at 4 months was predicted by health status, Self-monitoring and Insight and 'Hassles' in health services. Perceived health status at 4 months was predicted by age and patient experience of multimorbidity. CONCLUSIONS: This research shows that different factors, particularly around patients' experiences of health care and control over their treatment, impact on various types of self-management. Patient experience of multimorbidity was not a critical predictor of self-management but did predict health status in the short term. The findings can help to develop and target interventions that might improve outcomes in patients with multimorbidity.

The potential for using a Universal Medication Schedule (UMS) to improve adherence in patients taking multiple medications in the UK: a qualitative evaluation.

BACKGROUND: Poor adherence to prescribed medication has major consequences. Managing multiple long-term conditions often involves polypharmacy, potentially increasing complexity and the possibility of poor adherence. As a result of the globally recognised problems in supporting adherence to medication, some researchers have proposed the use of reminder charts. The main aim of the research was to explore the need for and perceptions around the 'Universal Medication Schedule' (UMS). Looking at ways in which pharmacists and General Practitioners (GPs) could use the UMS in NHS settings. METHODS: Semi-structured interviews were carried out with 10 GPs, 10 community pharmacists and 15 patients. Patients were aged 65 years and over, had multiple long-term conditions and were prescribed at least 5 medications. Interviews were recorded and transcribed and thematic analysis was conducted, using a framework approach to manage the data. RESULTS: Attitudes towards the UMS were mixed with stakeholders seeing benefits and limitations to the chart. Practitioners proposed a number of existing services where they thought the UMS could easily be integrated but there was evidence of role conflict with GPs feeling it may be best placed with pharmacists and vice versa. The potential for the UMS to be used as a tool to aid communication between the different services involved in a patient's care was a key theme. CONCLUSIONS: The UMS chart provides consolidated medicines information that might help to improve patients' knowledge and health literacy, which may or may not improve adherence but could help patients in making informed decisions about their treatment. One of the key benefits of using the UMS in practice is that it could be introduced across services. In this way it may aid in medicines reconciliation between healthcare settings to ensure continuity of message, improve patient experience and create more joined up working between services. Further research is needed to test implementation in different services and to assess outcomes on patient understanding and adherence.

What are the core predictors of 'hassles' among patients with multimorbidity in primary care? A cross sectional study.

BACKGROUND: A limitation of service delivery in primary care in the United Kingdom is that services are often organised to manage discrete long-term conditions, using guidelines related to single conditions, and managed in clinics organised around single conditions. However, many older patients have more than one condition (so called multimorbidity). Qualitative research suggests that these patients experience 'hassles' in their care, including multiple appointments, poor co-ordination, and conflicting recommendations. However, there is limited quantitative evidence on the 'hassles' that patients with multimorbidity experience, or factors predicting 'hassles' in patients with multimorbidity. METHODS: We conducted a cross sectional study, mailing questionnaires to 1460 patients with multimorbidity identified from the disease registers of four general practices in the UK. Patients were asked to complete a range of self-report measures including measures of multimorbidity, measures of their experience of multimorbidity and service delivery. Data were analysed using regression modelling to assess the factors predicting 'hassles' in patients with multimorbidity. RESULTS: In total 33% (n = 486) of patients responded to the baseline survey. The 'hassles' most often reported by patients related to lack of information about conditions and treatment options, poor communication among health professionals, and poor access to specialist care. There was a significant relationship between numbers of conditions, and reports of 'hassles'. In multivariate analysis, 5 variables predicted more 'hassles': more long-term conditions, symptoms of anxiety and depression, younger age, being in paid employment, and not having a discussion with their GP in the last 12 months. CONCLUSION: Hassles are frequently reported by patients with multimorbidity in primary care. A priority for future research should be on the development of new models of care that better cater for these patients. This research highlights core hassles that need to be addressed, and the patient groups that are most at risk, which may aid in the design of these new models.

Capacity, responsibility, and motivation: a critical qualitative evaluation of patient and practitioner views about barriers to self-management in people with multimorbidity.

BACKGROUND: Primary care is increasingly focussed on the care of people with two or more long-term conditions (multimorbidity). The UK Department of Health strategy for long term conditions is to use self-management support for the majority of patients but there is evidence of limited engagement among primary care professionals and patients with multimorbidity. Furthermore, multimorbidity is more common in areas of socioeconomic deprivation but deprivation may act as a barrier to patient engagement in self-management practices. BACKGROUND: Effective self-management is considered critical to meet the needs of people living with long term conditions but achieving this is a significant challenge in patients with multimorbidity. This study aimed to explore patient and practitioner views on factors influencing engagement in self-management in the context of multimorbidity. METHODS: A qualitative study using individual semi-structured interviews with 20 patients and 20 practitioners drawn from four general practices in Greater Manchester situated in areas of high and low social deprivation. RESULTS: Three main factors were identified as influencing patient engagement in self-management: capacity (access and availability of socio-economic resources and time; knowledge; and emotional and physical energy), responsibility (the degree to which patients and practitioners agreed about the division of labour about chronic disease management, including self-management) and motivation (willingness to take-up types of self-management practices). Socioeconomic deprivation negatively impacted on all three factors. Motivation was especially reduced in the presence of mental and physical multimorbidity. CONCLUSION: Full engagement in self-management practices in multimorbidity was only present where patients' articulated a sense of capacity, responsibility, and motivation. Patient 'know-how' or interpretive capacity to self-manage multimorbidity is potentially an important precursor to responsibility and motivation, and might be a critical target for intervention. However, individual and social resources are needed to generate capacity, responsibility, and motivation for self-management, pointing to a balanced role for health services and wider enabling networks.

Impact of research activity on performance of general practices: a qualitative study.

BACKGROUND: There is evidence that engaging in research is directly associated with better performance. If this relationship is to be strengthened, it is necessary to understand the mechanisms which might underlie that relationship. AIM: To explore the perspectives of staff and wider stakeholders about mechanisms by which research activity might impact on the performance of general practices. DESIGN & SETTING: Qualitative study using semi-structured interviews with general practice professionals and wider stakeholders in England. METHOD: Individual interviews with 41 purposively sampled staff in 'research ready' or 'research active' general practices and 21 other stakeholders. Interviews were independently coded by three researchers using a Framework approach. RESULTS: Participants described potential 'direct' and 'indirect' impacts on their work. 'Direct' impacts included research changing practice work (eg, additional records searches for particular conditions), bringing in additional resources (eg, access to investigations or staff) and improving relationships with patients. 'Indirect' impacts included job satisfaction (eg, perception of practice as a centre of excellence and innovation, and the variety afforded by research activity reducing burnout) and staff recruitment (increasing the attractiveness of the practice as a place to work). Respondents identified few negative impacts. CONCLUSIONS: Staff and stakeholders identified a range of potential impacts of research activity on practice performance, with impacts on their working lives most salient. Negative impacts were not generally raised. Nevertheless, respondents generally discussed potential impacts rather than providing specific examples of those impacts. This may reflect the type of research activity conducted in general practice, often led by external collaborators.

Users' views on the use of a smartwatch app to collect daily symptom data in individuals with multiple long-term conditions (Multimorbidity): A qualitative study.

Introduction: Long-term conditions are a major burden on health systems. One way to facilitate more research and better clinical care among patients with long-term conditions is to collect accurate data on their daily symptoms (patient-generated health data) using wearable technologies. Whilst evidence is growing for the use of wearable technologies in single conditions, there is less evidence of the utility of frequent symptom tracking in those who have more than one condition. Aims: To explore patient views of the acceptability of collecting daily patient-generated health data for three months using a smartwatch app. Methods: Watch Your Steps was a longitudinal study which recruited 53 patients to track over 20 symptoms per day for a 90-day period using a study app on smartwatches. Semi-structured interviews were conducted with a sub-sample of 20 participants to explore their experience of engaging with the app. Results: In a population of older people with multimorbidity, patients were willing and able to engage with a patient-generated health data app on a smartwatch. It was suggested that to maintain engagement over a longer period, more 'real-time' feedback from the app should be available. Participants did not seem to consider the management of more than one condition to be a factor in either engagement or use of the app, but the presence of severe or chronic pain was at times a barrier. Conclusion: This study has provided preliminary evidence that multimorbidity was not a major barrier to engagement with patient-generated health data via a smartwatch symptom tracking app.

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

BACKGROUND: The purpose of this 6-month intervention pilot feasibility randomised trial was to test sending brief messages using mobile phones to promote self-management through taking medication as prescribed to people with type 2 diabetes. This was to inform the design and conduct of a future large-scale United Kingdom-based clinical trial and establish the feasibility of recruitment, the technology used, follow-up, and data collection. METHODS: A multicentre individually randomised, controlled parallel group trial in primary care, recruiting adults (≥ 35 years) with type 2 diabetes in England. Consenting participants were randomly allocated to receive short message system text messages up to four times a week, or usual care, for a period of 6 months; messages contained behavioural change techniques targeting medication use. The primary outcome was the rate of recruitment to randomisation of participants to the trial with a planned rate of 22 participants randomised per month. The study also aimed to establish the feasibility of follow-up at 6 months, with an aim of retaining more than 80% of participants. Data, including patient-reported measures, were collected at baseline and the end of the 6-month follow-up period, and a notes review was completed at 24 months. RESULTS: The trial took place between 26 November 2018 and 30 September 2019. In total 209 participants were randomly allocated to intervention (n = 103) or usual care (n = 106). The maximum rate of monthly recruitment to the trial was 60-80 participants per month. In total, 12,734 messages were sent to participants. Of these messages, 47 were identified as having failed to be sent by the service provider. Participants sent 2,864 messages to the automated messaging system. Baseline data from medical records were available for > 90% of participants with the exception of cholesterol (78.9%). At 6 months, a further HbA1c measurement was reported for 67% of participants. In total medical record data were available at 6 months for 207 (99.0%) of participants and completed self-report data were available for 177 (84.7%) of participants. CONCLUSION: The feasibility of a large-scale randomised evaluation of brief message intervention for people with type 2 diabetes appears to be high using this efficient design. Failure rate of sending messages is low, rapid recruitment was achieved among people with type 2 diabetes, clinical data is available on participants from routine medical records and self-report of economic measures was acceptable. TRIAL REGISTRATION: ISCTRN ISRCTN13404264. Registered on 10 October 2018.

Six years on: a prospective cohort study of male juvenile offenders in secure care.

Longitudinal studies are helpful in understanding developmental trajectories and recognising opportunities for early intervention. This paper describes the long-term needs and mental health of an initial sample of male juvenile offenders, now adults 6 years after their index admission to secure care. In this prospective cohort study of 97 male juvenile offenders admitted to secure, offenders were assessed initially on admission, 2 and 6 years later. Interviews were conducted with 54 offenders at the 6-year follow-up and included an assessment of psychosocial need, mental health and psychopathy. Outcome data on offending behaviour were collected on a total of 71 offenders. Persistent offenders have needs in multiple domains as they transition into adulthood. The majority of offenders were single and about a half were in neither employment nor training. Almost nine out of ten offenders had a substance misuse disorder and a similar number met the criteria for a diagnosis of antisocial personality disorder. Substance misuse in adolescence was strongly correlated with later substance misuse in adulthood, emphasising the importance of early intervention. A diagnosis of antisocial personality disorder and living with friends and family were both significantly associated with persistent offending behaviour. Many offenders continued to reoffend despite receiving offence-related interventions and custodial care. Interventions currently aimed at reducing recidivism in more severe offenders appear to be ineffective. Persistent offenders would benefit from a multi-modal approach based on individual needs, rather than receiving generic interventions.

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.

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.

Cognitive behaviour therapy for adolescent offenders with mental health problems in custody.

Many studies have identified high levels of mental health problems among adolescents in custody and there is increasing evidence that mental health problems in this population are associated with further offending and mental health problems into adulthood. Despite recent improvements in mental health provision within custodial settings there is little evidence of structured interventions being offered or of their effectiveness being evaluated. A cognitively based intervention was developed and offered to adolescents with a variety of mental health problems in different secure settings, and the outcomes compared with a control group. Although this small-scale study did not identify significant differences in outcomes for the two groups, both recruitment and retention in therapy were good, and potential candidates were not excluded on the basis of learning difficulties or co-morbidity. The study demonstrated the viability of a delivering cognitively based intervention for common mental health problems within secure settings.

Prison staff and women prisoner's views on self-harm; their implications for service delivery and development: A qualitative study.

BACKGROUND: Rates of self-harm are high among women in prison in the UK. This is the first study to compare the views and attitudes of prison staff and women prisoners and to look at the effects of these attitudes on prisoner/staff relationships. AIMS: To explore understanding of self-harm among women prisoners, prison officers and health-care staff and how their perceptions might influence service provision and development. METHOD: Semi-structured interviews were conducted with women prisoners who self-harm and with staff at a women's prison. Data were analysed thematically. RESULTS: Prison officers often attributed motives to self-harm such as 'manipulation' and 'attention-seeking', whereas descriptions by women prisoners, prison governors and health-care staff suggested explanations in affect regulation or self-punishment. CONCLUSIONS: Differences between prison officers and other staff working in the prison in their understanding of self-harm by women prisoners may lie in training differences, but there may be other explanations such as self-protection/coping strategies. More training and support for officers may result in improved staff-prisoner relationships and thus, safer service provision.

Recruitment and methodological issues in conducting dementia research in British ethnic minorities: A qualitative systematic review.

OBJECTIVE: Identifying existing recruitment and methodological issues within dementia research conducted in UK studies that included ethnic minorities. METHODS: We searched for and included any publication detailing dementia research in the UK that included any ethnic minority. The search results and all titles and abstracts were screened according to the inclusion criteria followed by screening of the full texts. We extracted data regarding the recruitment and methodological issues faced by the researchers. This data was combined and listed, and related issues were grouped into overarching themes and subthemes. RESULTS: Of 52 publications suitable for analysis, 33 provided data collated into six themes: attitudes and beliefs about dementia in ethnic minority communities, recruitment process, data collection issues, practical issues, researcher characteristics, and lack of published research and normative data. These themes allowed us to identify three areas responsible for addressing these recruitment and methodological issues: community and patient education, health services, and researchers' training. CONCLUSIONS: This is the first review identifying recruitment and methodological issues within UK dementia research that included ethnic minorities. We now have a compilation of reported existing issues and a framework of areas responsible for addressing them and devising solutions.

Preventing depression in the community by voluntary sector providers (PERSUADE): intervention development and protocol for a parallel randomised controlled feasibility trial.

INTRODUCTION: Depression is now the most common illness worldwide affecting more than 300 million people. Studies modelling the impact of depression interventions have shown that the burden of depression cannot be minimised by more than 35% with existing treatments. There is a need to develop better preventative interventions. The overall aim of this programme of work is to develop interventions to reduce depression symptom scores and prevent development of depression in people with subthreshold depression. The objectives are to adapt a low intensity community-based depression prevention intervention, establish the acceptability and uptake of this model and conduct a parallel randomised controlled feasibility trial to inform a full-scale trial. METHODS AND ANALYSIS: Focus groups will be run with members of the public, voluntary sector providers and researchers to inform the adaptation of an existing depression prevention course. Sixty-four people with subthreshold depression, as represented by a score of between 5 and 9 on the Patient Health Questionnaire-9 depression measure, will be recruited to take part in the feasibility trial. Participants will be randomised equally to the intervention or usual care control groups. Participants in the intervention group will receive the new revised manual and attend a 1-day workshop delivered by voluntary sector service providers. Outcome measures will be completed 3 months after baseline. Quantitative data on recruitment, randomisation, attendance, retention, questionnaire completion rates will be collected. Primary analyses will be descriptive and a process evaluation will be conducted to assess the processes involved in implementing the intervention. Interviews will be conducted to explore acceptability and framework analysis will be used to analyse the data. ETHICS AND DISSEMINATION: The study has been reviewed and approved by NHS Research and Ethics Committee: NW-Greater Manchester East. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media, the internet and community engagement activities. TRIAL REGISTRATION NUMBER: ISRCTN23278208;Pre-results.

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.

Dementia in UK South Asians: a scoping review of the literature.

OBJECTIVE: Over 850 000 people live with dementia in the UK. A proportion of these people are South Asians, who make up over 5% of the total UK population. Little is known about the prevalence, experience and treatment of dementia in the UK South Asian population. The aim of this scoping review is to identify dementia studies conducted in the UK South Asian population to highlight gaps in the literature which need to be addressed in future research. METHOD: Databases were systematically searched using a comprehensive search strategy to identify studies. A methodological framework for conducting scoping reviews was followed. An extraction form was developed to chart data and collate study characteristics and findings. Studies were then grouped into six categories: prevalence and characteristics; diagnosis validation and screening; knowledge, understanding and attitudes; help-seeking; experience of dementia; service organisation and delivery. RESULTS: A total of 6483 studies were identified, 27 studies were eligible for inclusion in the scoping review. We found that studies of prevalence, diagnosis and service organisation and delivery in UK South Asians are limited. We did not find any clinical trials of culturally appropriate interventions for South Asians with dementia in the UK. The existing evidence comes from small-scale service evaluations and case studies. CONCLUSIONS: This is the first scoping review of the literature to identify priority areas for research to improve care for UK South Asians with dementia. Future research should first focus on developing and validating culturally appropriate diagnostic tools for the UK South Asians and then conducting high-quality epidemiological studies in order to accurately identify the prevalence of dementia in this group. The cultural adaptation of interventions for dementia and testing in randomised controlled trials is also vital to ensure that there are appropriate treatments available for the UK South Asians to access.

Self-management interventions in patients with long-term conditions: a structured review of approaches to reporting inclusion, assessment, and outcomes in multimorbidity.

BACKGROUND: Multimorbidity has many potential implications for healthcare delivery, but a particularly important impact concerns the validity of trial evidence underpinning clinical guidelines for individual conditions. OBJECTIVE: To review how authors of published trials of self-management interventions reported inclusion criteria, sample descriptions, and consideration of the impact of multimorbidity on trial outcomes. METHODS: We restricted our analysis to a small number of exemplar long-term conditions: type 2 diabetes mellitus, coronary heart disease, and chronic obstructive pulmonary disease. We focussed our search on published Cochrane reviews. Data were extracted from the trials on inclusion/exclusion, sample description, and impact on outcomes. RESULTS: Eleven reviews consisting of 164 unique trials were identified. Sixty percent of trials reported excluding patients with forms of multimorbidity. Reasons for exclusion were poorly described or defined. Reporting of multimorbidity within the trials was poor, with only 35% of trials reporting on multimorbidity in their patient samples. Secondary analyses, exploring the impact of multimorbidity, were very rare. CONCLUSIONS: The importance of multimorbidity in trials is only going to become more important over time, but trials often exclude patients with multimorbidity, and reporting of multimorbidity in trials including such patients is generally poor. This limits judgements about the external validity of the results for clinical populations. A consistent approach to the conduct and reporting of secondary analyses of the effects of multimorbidity on outcomes, using current best-practice guidance, could lead to a rapid development of the evidence base.