COPe-support - a multi-component digital intervention for family carers for people affected by psychosis: study protocol for a randomized controlled trial.

BACKGROUND: Psychosis often causes significant distress and impacts not only in the individuals, but also those close to them. Many relatives and friends ('carers') provide long-term support and need resources to assist them. We have co-produced a digital mental health intervention called COPe-support (Carers fOr People with Psychosis e-support) to provide carers with flexible access to high quality psychoeducation and interactive support from experts and peers. This study evaluates the effectiveness of COPe-support to promote mental wellbeing and caregiving experiences in carers. METHODS: This study is a single-blind, parallel arm, individually randomized controlled trial (RCT) comparing COPe-support, with attention control. Both groups continue to receive usual care. COPe-support provides interactive web-based psychoeducation on psychosis-related issues, wellbeing-promotion and network support through forums. The attention-control is a non-interactive online information resource pack. Carers living in England are eligible if they provide at least weekly support to a family member or close friend affected by psychosis, and use internet communication (including emails) daily. All trial procedures are run online, including collection of outcome measurements which participants will directly input into our secure platform. Following baseline assessment, a web-based randomization system will be used to allocate 360 carers to either arm. Participants have unlimited access to the allocated condition for 40 weeks. Data collection is at three time points (10, 20, and 40 weeks after randomization). Analyses will be conducted by trial statisticians blinded to allocation. The primary outcome is mental wellbeing measured by Warwick Edinburgh Mental Wellbeing Scale (WEMWBS), at 20 weeks. As well as an intention-to-treat analysis, a complier average causal effect (CACE) analysis will be conducted to estimate the intervention effect in participants who have accessed COPe-support content twice or more. The secondary objectives and analysis will examine other health and caregiving-related outcomes and explore mechanisms. In a process evaluation, we will interview 20% of the intervention arm participants regarding the acceptability of COPe-support. We will explore in detail participants' usage patterns. DISCUSSION: The results of this trial will provide valuable information about the effectiveness of COPe-support in promoting wellbeing and caregiving experiences in carers. TRIAL REGISTRATION: The RCT is registered with the Current Controlled Trials registration (ISRCTN 89563420, registration date: 02/03/2018)

Evidence generation for the clinical impact of myCOPD in patients with mild, moderate and newly diagnosed COPD: a randomised controlled trial

Self-management interventions in COPD aim to improve patients’ knowledge, skills and confidence to make correct decisions, thus improving health status and outcomes. myCOPD is a web-based self-management app known to improve inhaler use and exercise capacity in individuals with more severe COPD. We explored its impact in patients with mild-moderate or recently diagnosed COPD through a 12-week, 34open-label, parallel-group, randomised-controlled trial of myCOPD compared with usual care. The co-primary outcomes were between group differences in mean COPD assessment test (CAT) score at 90 days and critical inhaler errors. Key secondary outcomes were app usage and patient activation measurement (PAM) score. 3860 patients were randomised (29 myCOPD, 31 usual care). Groups were balanced for FEV1% predicted but baseline imbalance between groups for exacerbation frequency and CAT score. There was no significant adjusted mean difference in CAT score at study completion, -1.27 (95% CI -4.47 to 1.92, p=0.44) lower in COPD. However increasing app use associated with greater CAT score improvement. The odds of ≥1 critical inhaler error was lower in the myCOPD arm (adjusted odds ratio of 0.30 (0.09; 431.06, p=0.061)). The adjusted odds ratio for being in a higher PAM level at 90 days was 1.65 (0.46; 5.85) in favour of myCOPD. The small sample size and phenotypic difference between groups limited our ability to demonstrate statistically significant evidence of benefit beyond inhaler technique. However, our findings provide important insights into associations between increased app use and clinically meaningful benefit 48warranting further study in real world settings

The possibilities and limits of political contestation in times of ‘urban austerity’

This paper seeks to provide a conceptual framework in which to examine the social practices of contemporary austerity programmes in urban areas, including how these relate to different conceptions of crisis. Of current theoretical interest is the apparent ease with which these austerity measures have been accepted by urban governing agents. In order to advance these understandings we follow the recent post-structuralist discourse theory ‘logics’ approach of Glynos and Howarth (2007), focusing on the relationship between hegemony, political and social logics, and the subject whose identificatory practices are key to understanding the form, nature and stability of discursive settlements. In such thinking it is not only the formation of discourses and the mobilisation of rhetoric that are of interest, but also the manner in which the subjects of austerity identify with these. Through such an approach we examine the case of the regeneration/economic development and planning policy area in the city government of Birmingham (UK). In conclusion, we argue that the logics approach is a useful framework through which to examine how austerity has been uncontested in a city government, and the dynamics of acquiescence in relation to broader hegemonic discursive formations

Can digital health apps provide patients with support to promote structured diabetes education and ongoing self-management? A real-world evaluation of myDiabetes usage

Objective Structured diabetes education has evidenced benefits yet reported uptake rates for those referred to traditional in-person programmes within 12 months of diagnosis were suboptimal. Digital health interventions provide a potential solution to improve diabetes education delivery at population scale, overcoming barriers identified with traditional approaches. myDiabetes is a cloud-based interactive digital health self-management app. This evaluation analysed usage data for people with type 2 diabetes focusing on digital structured diabetes education. Methods Descriptive quantitative analyses were conducted on existing anonymised user data over 12 months (November 2019–2020) to evaluate whether digital health can provide additional support to deliver diabetes education. Data was divided into two equal 6-month periods. As this overlapped the onset of COVID-19, analyses of its effect on usage were included as a secondary outcome. All data was reported via myDiabetes. Users were prescribed myDiabetes by National Health Service healthcare primary care teams. Those who registered for app use within the study period (n = 2783) were assessed for eligibility (n = 2512) and included if activated. Results Within the study period, n = 1245/2512 (49.6%) registered users activated myDiabetes. No statistically significant differences were observed between gender (p = 0.721), or age (p = 0.072) for those who activated (59.2 years, SD 12.93) and those who did not activate myDiabetes (57.6 years, SD 13.77). Activated users (n = 1119/1245 (89.8%)) viewed 11,572 education videos. No statistically significant differences were observed in education video views across age groups (p = 0.384), gender (p = 0.400), diabetes treatment type (p = 0.839) or smoking status (p = 0.655). Comparison of usage pre-COVID-19 and post-COVID-19 showed statistically significant increases in app activity (p ≤0.001). Conclusion Digital health is rapidly evolving in its role of supporting patients to self-manage. Since COVID-19 the benefits of digital technology have become increasingly recognised. There is potential for increasing diabetes education rates by offering patients a digital option in combination with traditional service delivery which should be substantiated through future research

Mental health and caregiving experiences of family carers supporting people with psychosis.

AIMS: Family carers supporting an individual with psychosis often experience poorer mental health, however, little is known about specific risk factors among these carers. We investigated the associations between demographic, caregiving characteristics and mental health outcomes in family carers supporting an individual with psychosis and compared carers' outcomes with general population norms. METHODS: We analysed baseline data from the COPe-support randomised controlled trial of online psychoeducation and peer support for adult carers supporting an individual with psychosis between 2018 and 2020. We collected carers' demographic and health outcome data, including wellbeing using Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS as primary outcome), quality of life using EQ-5D-5L and caregiving experience assessed with Experience of Caregiving Inventory. We tested associations between carers' demographic and caregiving characteristics for each outcome in turn and meta-analysed carers' WEMWBS and EQ-5D-5L with Health Survey England (HSE) general population data from 2016 and 2017, respectively. RESULTS: The 407 carers of people with psychosis had a mean WEMWBS score of 42.2 (s.d. 9.21) and their overall weighted pooled WEMWBS score was 7.3 (95% confidence interval (CI) -8.6 to -6.0, p < 0.01) lower than the HSE general population sample, indicating carers have poorer mental wellbeing by more than double the minimum clinically important difference of 3 points on WEMWBS. Among all caring relationships, partners had poorer wellbeing compared to parents with lower WEMWBS score (-6.8, -16.9 to 3.3, p = 0.03). Single carers had significantly poorer wellbeing (-3.6, -5.6 to -1.5, p < 0.01) and a more negative caregiving experience than those who were cohabiting. Spending more than 35 h per week caregiving increased carers' negative experience significantly (p = 0.01). CONCLUSION: Carers of people with psychosis have poorer mental health than non-carers. Partners, lone carers and those spending more than 35 h per week on caring were found to be most at risk of poor mental health. Based on the results, we advocate that the details of carers for individuals with psychosis should be added to the existing carers or severe mental illness registers at all general practitioner surgeries and for their wellbeing screened routinely. Future large-scale prospective studies are needed to develop a predictive model to determine risk factors, hence to aid early identification of carers' support needs. Such understandings are also useful to inform tailored intervention development

Perceived acceptability and experience of COPe-support - a digital psychoeducation and peer support intervention: Interview study with carers supporting individuals with psychosis

Background: Digital mental health interventions offer a novel, accessible and self-paced approach to care delivery to family carers, i.e., relatives and close friends who support a loved one with psychosis. We co-produced COPe-support, a psychoeducational intervention delivered via an enriched online environment with network support from professionals and peers. In addition to rigorous investigation of the effectiveness of COPe-support on carers’ wellbeing and mental health outcomes, it is imperative to understand carers’ experiences in using the digital intervention and its associated online implementation and facilitation strategies. Objective: This study aimed to explore (1) carers’ experience and perceived acceptability of COPe-support and its different components, and (2) how they found engagement with COPe-support affected their own wellbeing and caregiving. Methods: We conducted a qualitative study, individually interviewing 35 carers after their use of COPe-support for 8 months through an online randomised controlled trial across England. A semi-structured guide with open-ended questions was used to explore carers’ experience and perceived acceptability of the intervention, and their ideas to improve the provision. All interviews were conducted remotely through mobile phone or internet communication media, audio-recorded, and transcribed verbatim. We used the thematic analysis framework approach to analyse the data. Results: Three key themes were identified: (i) remote, flexible and personalised, (ii) impacts on well-being and outlook on caregiving, and (iii) future implementation and integration with existing services. Overall, carers identified COPe-support as a helpful resource for themselves and for their caregiving role. Participants’ experiences, usage and activity on COPe-support varied a great deal and differed amongst carers of various ages and level of computer literacy. Conclusions: Carers found COPe-support a flexible source of knowledge and support from professionals and peers which they can personalise to suit their own needs and convenience. Participants described gaining self-confidence, hope, and a sense of connectivity with others in a similar situation which helped ameliorate isolation and perceived stigma. Most importantly, COPe-support promoted self-care in the carers themselves. While nearly all participants had a positive experience with COPe-support and supported its wider implementation as a beneficial adjunctive support resource for carers in the future, they suggested some improvements. These include having more graphics and visual-audio content materials, improving the navigation and building in more interactional and customisation options to suit various users’ style (e.g. emoji reactions, live online chat, opting in-and-out of updates and choosing frequency of reminders). Any future scale-up of such an intervention should also consider factors pertinent to reaching more carers and integrating the digital resource with other conventional services. Clinical Trial: Current Controlled Trials registration ISRCTN 89563420

Effect of digital psychoeducation and peer support on the mental health of family carers supporting individuals with psychosis in England (COPe-support): a randomised clinical trial

Background Psychoeducation delivered face-to-face is effective in alleviating mental health morbidities in family carers of individuals with psychosis. However, research in such interventions delivered online is scarce. We evaluated the effectiveness of a digital multicomponent intervention—COPe-support—in improving carers' mental wellbeing and caregiving-related outcomes. Methods In this two-arm, individually randomised, superiority trial, people aged 18 years or older who provided at least weekly support in any format for a relative or close friend affected by psychosis across England were randomly assigned (1:1) to either COPe-support or a passive online information resource using an independent online system. Participants were recruited through 30 mental health UK National Health Service trusts. The study team were masked to allocation and assessment of outcomes as all data collection took place online. Participants had access to either condition for 40 weeks and were advised to spend at least half an hour per week over the initial 20 weeks to go through materials at their own pace and to allow time to integrate knowledge and skills learned into practice. It was not feasible to mask participants or the online facilitator to intervention allocation. COPe-support provided psychoeducation on psychosis-related caregiving strategies and forums with professionals and other carers, and the control intervention comprised a passive online information resource. The primary outcome at 20 weeks was mental wellbeing measured by the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS; minimally clinically important difference [MCID] 3). This trial is registered with ISRCTN, 89563420. Findings Between March 1, 2018, and Feb 14, 2020, 407 participants were randomly assigned, with 204 allocated to COPe-support and 203 allocated to control. The participants (mean age 53·1 years, SD 13·2) were mostly female (330 [81%] of 407 participants) and White (359 [88%] of 407 participants). 346 (85%) of 407 participants provided primary endpoint data, 174 (85%) of 204 participants in the COPe-support group and 172 (85%) of 203 participants in the control group. The mean WEMWBS score at 20 weeks was 44·5 (SD 8·31) for the COPe-support group and 43·3 (9·19) for the control group. We found no evidence of a difference in wellbeing between the two groups (adjusted mean difference 0·37, 95% CI –1·14 to 1·88; p=0·63). In the COPe-support group, 106 (52%) of 204 participants met the complier definition of a minimum of two logins in separate weeks. The complier average causal effect analysis increased the difference in WEMWBS scores (adjusted difference 0·83, 95% CI –1·45 to 3·11; p=0·47), but this was lower than the MCID. There were no adverse events. Interpretation Our findings did not support the use of COPe-support over a passive online information resource. However, further research to optimise digital interventions adjunctive to face-to-face support for carers remains important

Consumer Multicultural Identity Affiliation: Reassessing Identity Segmentation in Multicultural Markets

The increasing intra-national diversity of many modern markets poses challenges to identity segmentation. As consumers require greater recognition of their diverse identities from brands, marketing science and practice are in search of theories and models that recognize and capture identity dynamics as impacted by cultural influences both from beyond and within national market borders. This paper extends consumer acculturation theory into multicultural market realities and offers a Consumer Multicultural Identity Affiliation (CMIA) Framework5 that distinguishes and integrates three key types of intra- and trans-national cultural influences informing identity dynamics. By examining consumer cultural identities within the CMIA framework in a mixed-method, two-country study, we show that gaining such an integrative view on cultural identity affiliations uncovers greater diversity and complexity (mono-, bi-, or multi-cultural) of consumer segments. We conclude with discussing future directions for CMIA applications to support marketing managers, scholars and educators dealing with culturally heterogeneous markets