Evaluating the effects of the World Health Organization's online intervention ‘iSupport’ to reduce depression and distress in dementia carers: a multi-centre six-month randomised controlled trial in the UK

Background Sustaining the capabilities of dementia carers is a global priority. ‘iSupport’ is a self-guided onlineintervention designed by the World Health Organization (WHO) to reduce mental health problems in dementiacarers. iSupport is undergoing global implementation, however there is an absence of effectiveness evidence. Thisstudy tested the effectiveness of iSupport to reduce distress and depression in dementia carers.Methods A pragmatic randomised controlled trial was conducted in three centres. Adult carers (18+) living in thecommunity were recruited in England, Wales and Scotland and randomly assigned (1:1) through a web-basedsystem to iSupport or usual care. Outcome assessors were masked to allocation. The primary outcomesassessed the difference in distress and depression between baseline and six-months. The target sample sizewas 350 to enable 90% power, significance at 2.5% including 25% attrition (262 completers) on eitheroutcome. Analysis followed the intention-to-treat (ITT) principle. The trial was registered with ISRCTNregistry (17420703).Findings Between 12th November 2021 and 31st March 2023,177 carers (50.3%) were randomised to usual care and175 (49.7%) to iSupport. 263 (74.7%) completed the trial. All were included in the ITT analysis. Mean distress scoresat six-months were 20.0 (SD = 8.3) for usual care and 20.6 (SD = 8.6) for iSupport. The mean difference was 0.16 (95%CI −1.17 to 1.49, p = 0.29) after adjusting for covariates. Mean depression scores at six-months were 9.5 (SD = 7.0) forusual care and 9.8 (SD = 6.5) for iSupport. The mean difference at six-months was −0.54 (95% CI = −1.70 to 0.62,p = 0.44). No serious adverse events were linked to the trial.Interpretation To our knowledge this is the largest trial evaluating a self-guided online intervention in UK dementiacarers, and the first to successfully evaluate the effectiveness of iSupport. The null findings are significant given theongoing global implementation of iSupport by the WHO and the adoption of self-guided interventions intomainstream care delivery as part of digital health transformations.Funding NIHR

Evaluating the effects of the World Health Organization's online intervention 'iSupport' to reduce depression and distress in dementia carers : a multi-centre six-month randomised controlled trial in the UK

Background: Sustaining the capabilities of dementia carers is a global priority. ‘iSupport’ is a self-guided online intervention designed by the World Health Organization (WHO) to reduce mental health problems in dementia carers. iSupport is undergoing global implementation, however there is an absence of effectiveness evidence. This study tested the effectiveness of iSupport to reduce distress and depression in dementia carers. Methods: A pragmatic randomised controlled trial was conducted in three centres. Adult carers (18+) living in the community were recruited in England, Wales and Scotland and randomly assigned (1:1) through a web-based system to iSupport or usual care. Outcome assessors were masked to allocation. The primary outcomes assessed the difference in distress and depression between baseline and six-months. The target sample size was 350 to enable 90% power, significance at 2.5% including 25% attrition (262 completers) on either outcome. Analysis followed the intention-to-treat (ITT) principle. The trial was registered with ISRCTN registry (17420703). Findings: Between 12th November 2021 and 31st March 2023,177 carers (50.3%) were randomised to usual care and 175 (49.7%) to iSupport. 263 (74.7%) completed the trial. All were included in the ITT analysis. Mean distress scores at six-months were 20.0 (SD = 8.3) for usual care and 20.6 (SD = 8.6) for iSupport. The mean difference was 0.16 (95% CI −1.17 to 1.49, p = 0.29) after adjusting for covariates. Mean depression scores at six-months were 9.5 (SD = 7.0) for usual care and 9.8 (SD = 6.5) for iSupport. The mean difference at six-months was −0.54 (95% CI = −1.70 to 0.62, p = 0.44). No serious adverse events were linked to the trial. Interpretation: To our knowledge this is the largest trial evaluating a self-guided online intervention in UK dementia carers, and the first to successfully evaluate the effectiveness of iSupport. The null findings are significant given the ongoing global implementation of iSupport by the WHO and the adoption of self-guided interventions into mainstream care delivery as part of digital health transformations. Funding: NIHR

Cost-consequence analysis of an e-health intervention to reduce distress in dementia carers : results from the iSupport randomised controlled trial

Objective: The use of e-health interventions has grown in demand due to their accessibility, low implementation costs and their potential to improve the health and well-being of people across a large geographical area. Despite these potential benefits, little is known about the cost-effectiveness of self-guided e-health interventions. The aim of the study was to compare the cost and consequences of ‘iSupport’, an e-health intervention to reduce mental health issues in dementia carers. Design: A cost-consequence analysis (CCA) of a multi-centre, single-blind randomised controlled trial of iSupport. The CCA was conducted from a public sector (National Health Service, social care and local authority) perspective plus a wider societal perspective. Delivery costs of iSupport were collected using a bottom-up micro-costing approach. Setting: 352 participants were recruited from three centres in England, Wales and Scotland. Participants: Participants eligible for inclusion were adults over the age of 18 years who self-identified as an unpaid carer with at least 6 months of experience caring for an individual with a diagnosis of dementia. Between 12 November 2021 and 31 March 2023, 2332 carers were invited to take part in the study. 352 participants were randomised: 175 randomised to the iSupport intervention group and 177 to the usual care control group. The mean age of participants in the intervention and control groups was 63 and 62, respectively. Main outcome measures: The CCA presented the disaggregated costs and health-related quality of life measured using the EuroQol five-dimension. Results: There was no significant difference in generic health-related quality of life measured using the EQ-5D-5L (p=0.67). Both groups reported higher mean costs between baseline and 6 months, but the change in costs was significantly lower in the intervention group. Between baseline and 6 months, the mean change in total resource use costs from the public sector perspective was significantly different between groups (p=0.003, r=−0.161) reporting a mean change per participant of £146 (95% CI: −33 to 342) between the intervention and control groups. From the wider societal perspective, there was no significant difference (p=0.23) in the mean change in total resource use and informal care costs between the two groups from baseline to 6 months. Conclusion: Use of iSupport was associated with reduced health and social care resource use costs for carers compared with care-as-usual. Self-guided e-health interventions for dementia carers may have the potential to reduce health and social care resource use and wider societal costs, but evidence relating to their effectiveness and cost-effectiveness is lacking. Trial registration number: ISRCTN17420703

A process evaluation of the UK randomised trial evaluating ‘iSupport’, an online e-health intervention for adult carers of people living with dementia

Supporting dementia carers is a global priority. As a Randomised Controlled Trial (RCT) (n = 352) of the Word Health Organization recommended, an internationally disseminated ‘iSupport’ e-health intervention was conducted, revealing no measurable benefits to the wellbeing of adult dementia carers. This process evaluation contributes original insights of the trial outcomes. Its aims were to ascertain the usability and acceptability of iSupport, participant engagement and adherence to iSupport, and contextual factors influencing its implementation and potential impact. The process evaluation followed a mixed-method design. The following data were collected from all participants randomised to iSupport (n = 175): (1) post-intervention evaluation questionnaire (n = 93) containing the 10-item System Usability Scale and bespoke items exploring acceptability, engagement, and perceived impact; (2) qualitative interviews (n = 52) with a sub-sample of participants who were purposively sampled according to age, scores on the outcome measures, and gender, as these interviews aimed to generate contextual detail and explanatory accounts; and (3) ‘Access’ data from the iSupport platform (n = 175). Descriptive statistics was used to report on the frequency of survey responses whilst a thematic analysis approach was followed to identify themes from the qualitative interview data. Data sets were analysed independently and then used with respect to one another in order to generate explanatory pathways related to the usability, acceptability, and the impact of iSupport. Despite good trial retention, 8.3% of participants (n = 32) did not spend any time on iSupport, and 54% (n = 94) spent between 30 min and 1.5 h. Factors driving this were the following: time constrains, method of delivery, and content characteristics. Positive impacts of iSupport were also described. Participants, including those with extensive caring experience, reported how iSupport had made them feel reassured, valued, and more able to ask for help. They also reported having an improved outlook on their caring role and on the needs and feelings of the person living with dementia. Research and practice should focus on exploring blended delivery, including self-directed and interactive components, such as regular contact with a health professional. These insights are critical for supporting the global implementation and adaptation of iSupport and offer valuable directions for future research

The effect of daily mentalization changes in daily mood in a community sample of adolescents: the role of emotion regulation and perceived stress

Mentalization is the ability to interpret one’s and other’s thoughts, feelings, and intentions (Bateman & Fonagy, 2019). Mentalization develops throughout childhood and adolescence, playing a crucial role in shaping social cognition, empathy, and interpersonal relationships. Research evidence suggests that mentalization is a key concept component to understanding mental health and well-being, but its effects on daily life are still unknown (Luyten et al., 2020). This study aims to explore how daily mentalization abilities impact the mood of young people in a community sample controlling by perceived stress and coping strategies

The accuracy and timeliness of a Point Of Care lactate measurement in patients with Sepsis

BACKGROUND: The aims of this study were to a) compare the lactate measurement of a Point of Care (POC) handheld device to near patient blood gas analysers, and b) determine the differential reporting times between the analysers. METHODS: A two-staged study; method comparison and prospective observational stages, was conducted. For the first stage, blood samples were analysed on the i-STAT handheld device and the near patient blood gas analysers (GEM 4000 and OMNI S). Results were compared using Pearson correlation coefficient and Bland-Altman tests. For the second stage, we examined the differential reporting times of the POC device compared to the near patient blood gas analysers in two Scottish hospitals. Differential reporting times were assessed using Mann–Whitney test and descriptive statistics were reported with quartiles. RESULTS: Highly significant Pearson correlation coefficients (0.999 and 0.993 respectively) were found between i-STAT and GEM 4000 and OMNI S. The Bland-Altman agreement method showed bias values of −0.03 and −0.24, between i-STAT and GEM 4000 and OMNI S respectively. Median time from blood draw to i-STAT lactate results was 5 min (Q1–Q3 5–7). Median time from blood draw to GEM 4000 lactate results was 10 min (Q1–Q3 7.75–13). Median time from blood draw to OMNIS lactate results was 11 min (Q1–Q3 8–22). The i-STAT was significantly quicker than both the GEM 4000 and the OMNIS (each p-value < 0.001). In addition, 18 of our study samples were sent to the central laboratory for analysis due to a defect in the lactate module of OMNI S. The median time for these samples from blood draw to availability of the central laboratory results at the clinical area was 133 min. CONCLUSIONS: The POC handheld device produced accurate, efficient and timely lactate measurements with the potential to influence clinical decision making sooner

Erratum to:The accuracy and timeliness of a point of care lactate measurement in patients with sepsis

After publication of the original article [1], the authors noticed a mistake in Table 2. Patient numbers in lactate classification categories Low, Medium and High were incorrectly reported as forty one, seven and two respectively in the GEM 4000 column. The patient numbers that should have been reported in Table 2 are forty, three and seven. Table 2 appears in its correct form in this erratum. Additionally, the incorrect patient numbers from Table 2 were reported in the 'Results' section. The 'Comparison of i-STAT against GEM premier 4000' sub-section should therefore have read as follows: "Among the 50 samples (from 11 ICU patients) analysed on the GEM4000 and the i-STAT; there were forty samples classified as low, three samples as medium and seven samples as high lactate risk level categories." This mistake does not alter the validity of the results and conclusions as all lactate samples analysed on the i-STAT and GEM 4000 analysers fell in the same lactate risk categories.</p

Diagnostic test accuracy of self-administered cognitive assessment tools for dementia

Background Dementia is a chronic and progressive clinical syndrome that can present with a range of cognitive and behavioural symptoms. Global prevalence is projected to increase due to ageing populations, particularly in resource‐limited settings, with significant associated health and social care costs. There is a critical need for accurate cognitive assessment as part of the diagnostic workup for dementia. Although self‐administered cognitive assessment tools are not diagnostic, they can be used to assess cognition. The role of these tests is uncertain, and their diagnostic test accuracy remains unclear, but they may be useful tools in circumstances where face‐to‐face assessment may be difficult. Objectives Primary objective To assess the test accuracy of any self‐administered cognitive assessment tool for the diagnosis of any form of dementia in any setting, including community and secondary health care. Secondary objectives To identify: the quality and quantity of the research evidence describing test accuracy of self‐administered testing; sources of heterogeneity in the test accuracy described; and gaps in the evidence where further research is required. Search methods We searched MEDLINE (Ovid SP), Embase (Ovid), Web of Science ‐ BIOSIS Citation Index, PsycINFO (Ovid), LILACS (BIREME), and CINAHL (EBSCO). The most recent searches were run on 2 November 2022. Selection criteria We included cross‐sectional studies investigating the accuracy of a self‐administered cognitive assessment tool. We included all settings, including community and secondary health care. The target condition of interest was a clinical diagnosis of dementia, therefore, we included only studies where the index test was administered alongside a reference standard clinical assessment. Our population of interest was any adult (over 18 years of age). Data collection and analysis Two review authors independently reviewed included studies, assessed risk of bias using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS‐2) tool, and extracted data. We obtained information on study design and participant characteristics, setting of index test, details of index text, reference standard used, and results reported as sensitivity and specificity. We performed a meta‐analysis on three studies that used the same threshold score. Main results The review included 11 eligible studies, with a total of 2303 participants, which evaluated the diagnostic test accuracy of six different self‐administered cognitive‐assessment tools. The studies were conducted in Europe, North America, and South Korea within a variety of community and healthcare settings. Our quality assessment found that four studies had a low risk of bias across all domains. Six studies had a high or unclear risk of bias due to patient selection, with concerns around lack of a clear sampling strategy or exclusion criteria, or both. Six studies had a high or unclear risk of bias with regard to the index test due to lack of information about how the test was conducted and evaluated. For the diagnosis of dementia, sensitivity of self‐administered cognitive assessment tools ranged from 55% to 100% and specificity ranged from 45% to 100%. Three studies described the diagnostic test accuracy of Test Your Memory at a threshold of 42/50. Quantitative meta‐analysis estimated a summary point with 94% sensitivity (95% confidence interval (CI) 90% to 96%) and 66% specificity (95% CI 45% to 82%) at this threshold. Authors' conclusions There is insufficient evidence to recommend the use of any single self‐administered cognitive assessment tool. The tools had test accuracy scores that are similar to the range seen with standard pencil and paper cognitive screening tests conducted by clinicians. Further research on the optimal test and threshold score, and how that may be impacted by setting, language, and educational level is needed