Perceived Acceptability and Experiences of a Digital Psychoeducation and Peer Support Intervention (COPe-support): Interview Study With Carers Supporting Individuals With Psychosis.

BACKGROUND: Web-based mental health interventions offer a novel, accessible, and self-paced approach to care delivery to family carers (ie, relatives and close friends who support a loved one with psychosis). We coproduced COPe-support (Carers fOr People with Psychosis e-support), a psychoeducational intervention delivered via an enriched web-based learning environment with network support from professionals and peers. In addition to the rigorous investigation of the effectiveness of COPe-support on the well-being of carers and mental health outcomes, it is imperative to understand the experiences of using the web-based intervention by carers and its associated web-based implementation and facilitation strategies. OBJECTIVE: This study aims to explore the experiences of carers and perceived acceptability of COPe-support and its different components, how carers found engagement with COPe-support affected their own well-being and caregiving, and the ideas of carers for improving COPe-support and its delivery to inform any future wider implementation. METHODS: We conducted a qualitative study, individually interviewing 35 carers, following their use of COPe-support for 8 months through a web-based, randomized controlled trial across England. A semistructured guide with open-ended questions was used to explore the experiences of carers and perceived acceptability of the intervention and their ideas to improve the provision. All interviews were conducted remotely through mobile phones or internet communication media, audio recorded and transcribed verbatim. We used a thematic analysis framework to analyze the data. RESULTS: Three key themes were identified: remote, flexible, and personalized support; impacts on well-being and outlook on caregiving; and future implementation and integration with existing services. Overall, carers found COPe-support a flexible source of knowledge and support from professionals and peers that they could personalize 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 among the carers themselves. Participants' experiences, use, and activity on COPe-support varied greatly and differed among carers of various ages and levels of computer literacy. CONCLUSIONS: 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. Any future scale-up of such an intervention needs to consider feedback from carers and suggestions for further improvement. These included having more graphics and audiovisual content materials, improving the navigation, and building in more interactional and customization options to suit various user styles, such as emoji reactions, live web-based chat, opting in and out of updates, and choosing the frequency of reminders. To ensure successful implementation, we should also consider factors pertinent to reaching more carers and integrating the web-based resources with other conventional services. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN) 89563420; https://www.isrctn.com/ISRCTN89563420. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12888-020-02528-w.

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).

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. FUNDING: National Institute for Health Research.

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 the impact of myCOPD in patients with mild-moderate or recently diagnosed COPD through a 12-week, open-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. Sixty patients were randomised (29 myCOPD, 31 usual care). Groups were balanced for forced expiratory volume in 1 s (FEV1 % pred) but there was 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 -4.47-1.92, p=0.44) lower in myCOPD. However, an increase in app use was associated with greater CAT score improvement. The odds of ≥1 critical inhaler error was lower in the myCOPD arm (adjusted OR 0.30 (95% CI 0.09-1.06, p=0.061)). The adjusted odds ratio for being in a higher PAM level at 90 days was 1.65 (95% CI 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 warranting further study in real world settings.

A randomised controlled feasibility trial of E-health application supported care vs usual care after exacerbation of COPD: the RESCUE trial.

Exacerbations of COPD are one of the commonest causes of admission and readmission to hospital. The role of digital interventions to support self-management in improving outcomes is uncertain. We conducted an open, randomised controlled trial of a digital health platform application (app) in 41 COPD patients recruited following hospital admission with an acute exacerbation. Subjects were randomised to either receive usual care, including a written self-management plan (n = 21), or the myCOPD app (n = 20) for 90 days. The primary efficacy outcome was recovery rate of symptoms measured by COPD assessment test (CAT) score. Exacerbations, readmission, inhaler technique quality of life and patient activation (PAM) scores were also captured by a blinded team. The app was acceptable in this care setting and was used by 17 of the 20 patients with sustained use over the study period. The treatment effect on the CAT score was 4.49 (95% CI: -8.41, -0.58) points lower in the myCOPD arm. Patients' inhaler technique improved in the digital intervention arm (101 improving to 20 critical errors) compared to usual care (100 to 72 critical errors). Exacerbations tended to be less frequent in the digital arm compared to usual care; 34 vs 18 events. Hospital readmissions risk was numerically lower in the digital intervention arm: OR for readmission 0.383 (95% CI: 0.074, 1.987; n = 35). In this feasibility study of the digital self-management platform myCOPD, the app has proven acceptable to patients to use and use has improved exacerbation recovery rates, with strong signals of lower re-exacerbation and readmission rates over 90 days. myCOPD reduced the number of critical errors in inhaler technique compared to usual care with written self-management. This provides a strong basis for further exploration of the use of app interventions in the context of recently hospitalised patients with COPD and informs the potential design of a large multi-centre trial.