Reasonable access to brief behavioural insomnia treatment among medical and psychiatric outpatients (RABBIT): a multicentre randomised controlled trial protocol

Introduction
Insomnia is a significant global health issue associated with substantial economic costs. International guidelines recommend cognitive behavioural therapy for insomnia (CBT-I) as the first-line treatment for chronic insomnia; however, pharmacotherapy remains more common in clinical practice. Maintaining the effectiveness while reducing the time and frequency of CBT-I is essential for its implementation. We conducted a randomised controlled trial (RCT) to evaluate the effectiveness of a brief behavioural treatment for insomnia (BBTI) that focuses on sleep restriction and stimulus control (SC)—both established as effective standalone interventions. This article presents the study protocol to examine whether adding BBTI to treatment as usual improves outcomes in patients with chronic insomnia.

Methods and analysis
We will conduct a multicentre RCT. We will randomly assign patients with chronic insomnia to two groups (BBTI vs sleep hygiene) in a 1:1 ratio. The BBTI consists of three 15 min sessions over 4 weeks delivered by healthcare professionals following a detailed manual. The primary outcome is the Insomnia Severity Index at 8 weeks. Secondary outcomes include sleep latency, wake after sleep onset, total sleep time, sleep efficiency, Generalized Anxiety Disorder-7, Patient Health Questionnaire-9 and EuroQol-5D-5L. We will conduct the assessment at weeks 0 (baseline), 4 (end of intervention), 8 (post-intervention, primary endpoint) and 12 (follow-up). We will assess each sleep variable from the sleep diary at weeks 0 and 8. The analysis will be performed on an intention-to-treat basis.

Ethics and dissemination
This study has been approved by the Ethics Committee for Clinical and Epidemiological Research of Toyama University (approval no. R2023152).

Trial registration number
UMIN000052911; pre-results.

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Investigating biographical post-bariatric surgery uncertainties in the light of changes in bodily practices: a mixed-method, multicentric and longitudinal research protocol

Introduction
The effects of bariatric surgery have largely been studied from a medical viewpoint, seeking to measure changes in anthropometric, physiological or quality-of-life factors after the operation. Few studies, however, have focused on the dynamics of lifestyle changes. Yet we know that changing lifestyle habits—which are often part of the established social configurations at the origin of morbid obesity—is essential for a sustainable recovery from obesity. We also know that the major bodily transformations that occur in the six to twelve months following surgery produce a high degree of biographical uncertainty and affect social interactions. From a sociological perspective, the authors propose to study the processes of disruption and re-establishment of lifestyle habits in the first 24 months following bariatric surgery.

Methods and analysis
The ChiBarAPS study relies on a mixed-method longitudinal survey, comprising three components: qualitative, quantitative, literature and data review. It aims to document three main dimensions, which must be articulated to understand the dynamics of change: (1) the work undertaken by patients on themselves in order to identify and measure the evolutionary effects of surgery, as well as to adapt to them; (2) the experience of using pre- and post-surgery information and support systems, and evaluating their effects on the agency of the people who have undergone surgery; (3) the evolution of social participation and lifestyle habits. The qualitative component concerns a cohort of 30 patients, interviewed in depth (2 hours) on these three dimensions, 6 months, 12 months and 24 months after the operation. The quantitative part uses questionnaires applied to a second group of 200 patients, following the same timeline.

Ethics and dissemination
This study complies with reference methodology MR004 of the French National Data Protection Authority and was registered by the Data Protection Officer of the University of Montpellier on the activity registry of the institution (24 April 2024). Ethics approval has been obtained from the University of Montpellier ethics research board (n°UM2024-037). Informed consent will be obtained from all participants before data collection. The project has received funding from the French National Research Agency (n°ANR-23-CE41-0020-01) from February 2024 to the end of January 2028. The first results of the research will be disseminated from 2026 onwards to researchers, health professionals and patient support organisations. The results of the study will then be published in peer-reviewed scientific journals, both national and international.

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Prior Reperfusion Strategy Does Not Modify Outcome in Early Versus Late Start of Anticoagulants in Patients With Ischemic Stroke: Prespecified Subanalysis of the Randomized Controlled ELAN Trial

Stroke, Ahead of Print. BACKGROUND:Early initiation of direct oral anticoagulants (DOACs) in patients with nonvalvular atrial fibrillation and acute ischemic stroke is beneficial and safe. Whether prior acute reperfusion therapy modifies the treatment effect of early versus late DOAC initiation is unknown.METHODS:For this post hoc analysis of the multicenter, randomized controlled ELAN trial (Early Versus Late Initiation of Direct Oral Anticoagulants in Post-Ischaemic Stroke Patients With Atrial Fibrillation), all participants with data concerning reperfusion treatment were included. The primary outcome was the composite outcome of recurrent ischemic stroke, symptomatic intracranial hemorrhage, major extracranial bleeding, systemic embolism, or vascular death within 30 days. Patients were divided into 4 groups based on prior reperfusion therapy: no treatment, intravenous thrombolysis (IVT), endovascular treatment (EVT), or IVT combined with EVT. We performed logistic regression adjusted for age, hypertension, infarct location/size, pre-modified Rankin Scale, NIHSS, and hemorrhagic transformation, including the interaction term between treatment groups (early versus late DOAC) and reperfusion strategy.RESULTS:We included 1973 of 2013 (98%) patients of the ELAN trial population, with a median age of 77 (71–84) years and of whom 899 (46%) were female. Of them, 1015 (51%) underwent no prior reperfusion treatment, 519 (26%) IVT, 190 (10%) EVT, and 249 (13%) IVT+EVT. We did not identify an interaction for any of the outcome events between prior reperfusion therapy and timing of DOAC initiation. Rates were numerically lower in the early DOAC-initiated group for the following: no reperfusion therapy, 17 (3.3%) versus 24 (4.8%; adjusted odds ratio, 0.69 [95% CI, 0.36–1.28]); EVT, 1 (1.2%) versus 7 (6.4%; adjusted odds ratio, 0.25 [95% CI, 0.03–1.21]); and EVT+IVT, 3 (2.4%) versus 4 (3.3%; adjusted odds ratio, 0.76 [95% CI, 0.17–3.23]). In patients who had received IVT, the rates were 3% (n=8) in the early group versus 2% (n=5) in the late group (adjusted odds ratio, 1.52 [95% CI, 0.52–4.84]).CONCLUSIONS:Prior reperfusion therapy does not modify the effect of early versus late DOAC initiation on clinical outcomes in patients with atrial fibrillation and acute ischemic stroke.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT03148457.

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Mesenchymal intravenous stromal cell infusions in children with recessive dystrophic epidermolysis bullosa: MissionEB protocol for a randomised, double-blinded, placebo-controlled, two-centre, crossover trial with an internal phase I dose de-escalation phase and open-label extension

Introduction
Recessive dystrophic epidermolysis bullosa (RDEB) is a severe genetic mucocutaneous fragility disorder characterised by chronic blistering, slow wound healing and increased risk of squamous cell carcinoma. Current management options are very limited.

Methods
This is a randomised (1:1), placebo-controlled, double-blinded crossover (A/B) trial with an internal phase I dose de-escalation (4+5 design) in the first 3 months and a 12-month continued treatment follow-on open-label study if 3-month outcome data from the crossover trial indicate safe and beneficial effects. RDEB is a rare condition, so we expect to recruit a maximum of 36 participants based on feasibility and not formal power considerations. Participants aged >6 months and

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Stepped wedge cluster randomised controlled trial to assess the impact of a decision support tool for physical restraint use in intensive care units (ARBORea Study): a study protocol

Introduction
Intensive care units (ICUs) manage patients with or likely to have one or more life-threatening acute organ failures that might require the use of invasive supportive therapies. The use of physical restraint is frequent, with rates up to 50%, and usually initiated to maintain patient safety especially if the patient is agitated. Physical restraints have been associated with delirium, post-traumatic stress disorder and physical injuries while restricting patients’ individual freedom. Moreover, the incidence of invasive therapeutic devices’ self-removal by patients might not be decreased by physical restraint use. No recommendation is available concerning ICU patients and physical restraint management, despite being a daily practice. The main objective is to evaluate whether a strategy aimed at decreasing physical restraint use in ICU patients with that of a strategy based on routine and subjective caregivers’ decision is safe and efficient.

Methods and analysis
ARBORea is a multicentre randomised, stepped-wedge trial testing an innovative, dedicated web-based, multiprofessionally developed, experts validated, nursing management strategy in comparison with standard care. The primary outcome is physical restraint use rate (effectiveness) measured at least every 8 hours and incidents’ rate (tolerance) defined as the rate of incidents attributable to non-compliance, corresponding to the deterioration or self-removal of critical devices, a fall or self-aggressive or heteroaggressive behaviours. Planned enrolment is 4000 ICU adult participants at 20 French academic and non-academic centres. Safety and long-term outcomes will be evaluated.

Ethics and dissemination
Trial results will be reported according to the Consolidated Standards of Reporting Trials 2010 guidelines. Findings will be published in peer-reviewed journals and presented at local, national and international meetings and conferences to publicise and explain the research to clinicians, commissioners and service users. The trial is funded by the French Ministry of Health and has been approved by the French local ethics committee (Comité de Protection des Personnes Sud-Ouest et Outre-Mer 2, Toulouse, France with registration number: 2020-A02904-35).

Trial registration number
(ClinicalTrials.gov) NCT04957238 on 12 July 2021 before first inclusion in study.

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Enhancing dyadic outcomes of stroke survivors and caregivers: protocol for a randomised controlled trial

Introduction
Stroke is a leading cause of death and disability worldwide. Stroke survivors and their caregivers often face profound social isolation and various participation restrictions, resulting in frustration and adverse health outcomes. Dyad-focused interventions, which address both survivor and caregiver needs, are essential during the transition process. However, few interventions equally prioritise the outcomes of both survivors and caregivers. This study aims to evaluate the efficacy of a newly developed dyad-focused strategy training intervention in enhancing participation among stroke survivors and their caregivers.

Methods and analysis
This study employs a single-blind, parallel-group randomised controlled trial with allocation concealment and assessor blinding. We aim to enrol 138 stroke survivor-caregiver dyads, randomly assigned in a 1:1 ratio to either the experimental intervention group or the control group. Both groups will receive their usual rehabilitation plus 45–60 min sessions of the intervention twice weekly for a total of 12 sessions. Outcome measures, including the Participation Measure-3 Domains, 4 Dimensions, General Self-Efficacy Scale and Activity Measure for Post-Acute Care, will be collected at baseline, post-intervention and at 3-month, 6-month and 12-month follow-ups. Data will be analysed using multiple linear regression and mixed-effects regression models. Qualitative indepth interviews with participants, caregivers and therapists will be conducted post intervention, transcribed and thematically analysed.

Ethics and dissemination
Ethics approval was obtained from the Ethics Committee of Taipei Medical University (approval number: N202203083), National Taiwan University Hospital (approval number: 202207096RINA) and Taipei Tzu Chi Hospital (approval number: 11 M-107). Findings will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals.

Trial registration number
NCT05571150; Preresults.

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Synthesis using prospective meta-analysis to reduce youths e-cigarette use (SPARKE): a protocol for an individual participant data prospective meta-analysis (IPD PMA) examining interventions for the prevention of youth e-cigarette use

Introduction
Youth electronic cigarette (e-cigarette) use is a global health challenge, with multiple jurisdictions wrestling with appropriate responses, in the face of limited evidence available on effective interventions. Identifying and synthesising evidence on the effects of interventions to prevent youth e-cigarette use is required to inform prevention-focussed health policy and practice.

Methods and analysis
We plan to undertake an individual participant data (IPD) prospective meta-analysis (PMA). We will conduct systematic searches to identify eligible planned or ongoing randomised controlled trials (RCTs) using trial registries via WHO ICTRP and ClinicalTrials.gov and databases Medline, Embase, CENTRAL, PsycINFO, Web of Science, CINAHL and Europe PMC. We will also search grant websites for additional studies. We will include any RCT of e-cigarette and cigarette prevention interventions for youth including non-smoking and non-vaping youth aged 10 to 19 years, with no intervention, waitlist, usual care or active control. Primary outcomes will be measures of current or ever e-cigarette use. Secondary outcomes include measures of current and ever cigarette (conventional cigarette) use.
Investigators from relevant trials will be invited to join the Synthesis using Prospective meta-Analysis to Reduce youths’ E-cigarette use (SPARKE) consortium prior to trial outcomes being known using harmonised methods. They are then asked to share their data within 12 months of trial completion.
The primary outcomes will be analysed in a two-stage IPD meta-analysis model under an intention-to-treat framework. First, effect estimates and variances will be calculated for each trial with log-binomial regression models adjusting for key prognostic factors. For cluster RCTs, a nested random effect will be specified within trials to account for correlations within clusters. Second, effect estimates will be combined across trials in a random treatment effect, inverse variance meta-analysis model. Effect estimates will be reported as relative risk ratios with 95% CIs.

Discussion
This study aims to generate and expedite the synthesis of data regarding prevention interventions for adolescent e-cigarette use to inform real-world decision making. Findings will be of interest to key stakeholders, including policy makers and research funders.

Ethics and dissemination
Each trial will be responsible for obtaining their own ethics approval. While secondary analysis of data does not usually require ethics approval, we have received cross-institutional ethics approval from the University of Sydney (2023/714) and the University of Newcastle (H-2023–0389).

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What proportion of people have long-term pain after total hip or knee replacement? An update of a systematic review and meta-analysis

Objectives
To update our previous systematic review to synthesise latest data on the prevalence of long-term pain in patients who underwent total hip replacement (THR) or total knee replacement (TKR). We aim to describe the prevalence estimates and trends in this review.

Design
Systematic review and meta-analysis.

Data sources
Update searches were conducted in MEDLINE and Embase databases from 1 January 2011 to 17 February 2024. Citation tracking was used to identify additional studies.

Eligibility criteria
We included prospective cohort studies reporting long-term pain after THR or TKR at 3, 6, 12 and 24 months postoperative.

Data extraction and synthesis
Two reviewers independently identified studies as eligible. One reviewer conducted data extraction, checked by a second reviewer. The risk of bias assessment was performed using Hoy’s checklist. Bayesian, random-effects meta-analysis was used to synthesise the results.

Results
For TKR, 68 studies with 89 time points, including 598 498 patients, were included. Multivariate meta-analysis showed a general decrease in pain proportions over time: 21.9% (95% CrI 15.6% to 29.4%) at 3 months, 14.1% (10.9% to 17.9%) at 6 months, 12.6% (9.9% to 15.9%) at 12 months and 14.6% (9.5% to 22.4%) at 24 months. Considerable heterogeneity, unrelated to examined moderators, was indicated by substantial prediction intervals in the univariate models. Substantial loss to follow-up and risk of bias led to low confidence in the results. For THR, only 11 studies were included, so it was not possible to describe the trend. Univariate meta-analysis estimated 13.8% (8.5% to 20.1%) and 13.7% (4.8% to 31.0%) of patients experiencing long-term pain 6 and 12 months after THR, respectively, though concerns in risk of bias results reduced confidence in these findings.

Conclusions
Our review suggests that approximately 22% of patients report pain 3 months post-TKR, with 12%–15% experiencing long-term pain up to 2 years. At least 14% report pain 6–12 months after THR. Given the prevalence of chronic postsurgical pain, implementing existing and developing new preventive and management strategies is crucial for optimal patient outcomes.

PROSPERO registration number
CRD42023475498.

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Presentation of the Julius M. Friedenwald Medal to David Lieberman, MD, AGAF

It is our privilege to recognize David Lieberman as the 2025 recipient of the American Gastroenterological Association (AGA) Julius M. Friedenwald Medal. His nomination, seconded by 12 esteemed leaders in the field, reflects the deep respect and admiration for David’s contributions to gastroenterology. The Friedenwald Medal, AGA’s highest honor, has been awarded annually since 1941 to individuals who have made lifelong contributions to the field and to the AGA. Although a detailed biography of David was published in Gastroenterology in 2018 upon his appointment as AGA President, we are honored to highlight key aspects of his career that make him so deserving of this award.

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Qualitative exploration of the acceptability of a 12-week intervention to reduce sedentary behaviour among ethnically diverse older adults

Objective
The population of ethnically diverse older adults (OAs) is increasing in the UK; this group faces complex health challenges that are exacerbated by language difficulties, socioeconomic status and acculturation experiences. Moreover, this diverse group is the least active and sedentary subgroup within the wider population, which raises a major concern for their health and highlights the need for effective behaviour change interventions to motivate this group to be less sedentary. Therefore, this study aims to explore the acceptability of a 12-week intervention to reduce sedentary behaviour (SB) for ethnically diverse sedentary OAs.

Design
The study employed a qualitative approach to assess the acceptability of the 12-week single-arm intervention for reducing SB.

Setting
The study participants were recruited on a rolling basis from January to May 2024. The recruitment process was conducted through social community organisations and local religious groups in Swansea that provided leisure, sports and recreational activities for ethnically diverse OAs.

Participants
The target population for this study was ethnically diverse OAs aged ≥65 years (including women and men) among (n=20) OAs using in-depth interviews.

Intervention
The intervention consisted of a 40–60 minute personalised one-to-one in-person health coaching session, a wearable activity tracker to remind participants to take breaks from prolonged sitting time, a pamphlet and weekly reminder messages via a mobile phone.

Primary outcome
To assess the acceptability of the intervention.

Results
Reflexive thematic analysis was performed using a deductive approach by integrating four predetermined MRC framework themes. Four overarching themes were included in our analysis: (1) acceptability, (2) usability, (3) functionality and (4) recruitment and retention. OAs were satisfied with the intervention and found it effective and acceptable. The multicomponent intervention provided users with strategies to achieve the goal of reducing their sitting time and provided them with opportunities to be active and independent. In addition, there were personal (eg, health) and social (eg, family) factors that influenced their decision to participate in the intervention.

Conclusion
The findings of this study support the acceptability of the intervention with an ethnically diverse group of OAs. Initial evidence also suggests that the intervention has the potential to increase activity and minimise sitting time in ethnically diverse OAs and therefore will inform a future effectiveness trial. The inclusion of an ethnically diverse population in this study has helped us to understand the needs and challenges of these groups to identify how to design culturally sensitive interventions that are tailored according to their needs. These insights will be incorporated into the planned effectiveness trial.

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Changes in medical student attendance at in-person teaching sessions: a systematic review

Introduction
The COVID-19 pandemic has had a significant impact on medical education, with many institutions shifting to online learning to ensure the safety of students and staff. However, there appears to be a decline in in-person attendance at medical schools across the UK and worldwide following the relaxation of social distancing rules and the reinstatement of in-person teaching. Importantly, this trend was also observed before the pandemic. While reflected within the literature, there is currently no systematic review describing these changes. We aim to find out how medical students’ attendance is changing as documented within the literature and its impact on their educational outcomes.

Methods
This systematic review followed the guidelines of the Centre of Research and Dissemination, Moose and Preferred Reporting Items for Systematic Reviews and Meta-Analyses. We searched the major databases of Medline via Ovid, Embase via Ovid, Scopus, Web of Science, British Education Index via EBSCOhost and ERIC via EBSCOhost in September 2023. Two reviewers independently screened each paper and extracted the data, with a third reviewer for dispute resolution. All studies reporting on medical students from various universities, both graduate and undergraduate, and describing changes in attendance and/or students’ educational outcomes were included. Risk of bias in individual studies was assessed using the Agency for Healthcare Research and Quality tool. A narrative synthesis of the findings from all included studies was done.

Results
12 papers were included in the analysis. Primary aim: Of the eight papers that measured attendance data over more than one academic year, only one paper demonstrated a statistically significant decrease while one paper demonstrated a statistically significant increase in attendance over the observational period. Other papers either did not perform statistical tests or did not demonstrate statistical significance. Secondary aims: Most papers showed a general positive correlation between attendance and educational outcomes. No studies explicitly explored reasons for changes in attendance seen. Only one paper outlined a possible strategy to address changes in attendance, a mandatory attendance policy, which has mixed outcomes.

Discussion
Despite widespread anecdotally reported attendance decline post-COVID-19, overall, there was no consistent change in attendance noted. However, there was a large heterogeneity in the studies included. Further research is required to elucidate trends in attendance and its impact on medical education.

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Perceived acceptability, barriers and enablers in implementing mobile phone messaging-based message-framing intervention for improved maternal and newborn care in Jimma Zone, Ethiopia: a qualitative study

Objective
To explore the perceived acceptability, barriers and enablers in implementing mobile phone messaging-based message-framing interventions to improve maternal and newborn care in Jimma Zone, Ethiopia.

Design
A qualitative study employing thematic analysis of data collected through in-depth interviews (IDIs) and key informant interviews (KIIs).

Setting
The study was conducted in Dedo, Shabe Sombo and Manna districts of Jimma Zone.

Participants
We conducted 12 IDIs and 14 KIIs with pregnant women, male partners, health extension workers, healthcare providers and Ethio-Telecom experts across the three districts. Thematic analysis was used to identify patterns and themes in the data.

Intervention
Mobile phone messaging-based interventions using gain-framed and loss-framed messages were explored for their potential to promote maternal and newborn health practices.

Key areas of exploration
The study explored participants’ awareness, perceived relevance, acceptability, and barriers and enablers, as well as participants’ engagement with mobile health messaging interventions.

Results
Participants were generally aware of the potential benefits of mobile phone messaging for maternal and newborn health. Mobile phone-based messaging was perceived as highly relevant and useful by most participants. However, many had limited prior experience using mobile messaging for health information. Despite this, participants expressed a strong willingness and readiness to receive and actively engage with the maternal and newborn mobile messaging intervention. The study also identified various barriers and enablers affecting the implementation of message-framing interventions through mobile phone messaging.

Conclusions
Participants in this study generally recognised and accepted the benefits of mobile phone messaging for improving maternal and newborn health. Although rural women faced challenges in reading and understanding short messages, they demonstrated a strong willingness to engage with mobile health messaging interventions. The identified barriers were categorised as technological, social, cultural, behavioural and contextual. To maximise the impact of mobile health messaging and ensure broad and effective reach, it is crucial to address these barriers while leveraging existing enablers.

Trial registration number
This study was conducted as part of a larger cluster randomised controlled trial at Clinical trials PACTR202201753436676, 4 January 2022.

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Progress towards prevention of suicide in India by improving print media reporting of suicide news: a repeat content analysis study in Tamil Nadu

Objectives
Suicide rates in India are among the highest in the world, with the most recent suicide death rate estimates ranging between 18 and 21 deaths per 100 000 population (compared with the global average of 11/100 000). Responsible media reporting of suicide is one of the few evidence-based population-level suicide prevention interventions. Reports of recent suicides are a routine daily feature in major newspapers in India, and the reporting style carries many concerning features. In 2019, the Press Council of India adopted the WHO media guidelines, yet there has been no investigation as to whether this guidance is being followed. The aim of this paper was to systematically investigate whether the quality of print media reports of suicides has changed since the adoption of media guidelines for suicide reporting in India.

Design
We used content analysis to assess the quality of suicide reporting against WHO guidelines in nine of the most highly read daily newspapers in the southern state of Tamil Nadu between June and December 2016 and June and December 2023. Our analyses of changes in reporting were based on a sample of 1681 print newspaper articles from 2016 and 512 print newspaper articles from 2023. Two-tailed t-tests and proportion tests on aggregate means and frequencies assessed whether the reporting characteristics had changed between 2016 and 2023.

Results
There were small yet statistically discernible reductions in the proportion of articles containing various potentially harmful reporting characteristics, such as articles placed on the front page (4.9–1.8%, p=0.002) and articles mentioning the suicide method (92.7–86.5%, p

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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.

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