Parents of children with neurodevelopmental disorders often experience high levels of stress that impact their mental health, yet few interventions focus on their well-being. To address this gap, we developed a mental health intervention based on emotional intelligence (EI), designed for delivery in healthcare settings. We hypothesise that enhancing EI can reduce parenting stress and improve psychological well-being. This study aims to assess the effectiveness, cost-effectiveness and feasibility of this EI-based intervention in Bangladesh.

This hybrid type 1 effectiveness-implementation study will include a cluster randomised controlled trial, an implementation analysis and an economic evaluation. Eight child development centres will be randomly assigned in a 1:1 ratio to intervention and waitlist control groups. A total of 480 parents (mothers and fathers) will be recruited. The intervention consists of interactive sessions on EI skills, supported by personal diaries and a mobile app. Data will be collected at baseline and 12 weeks postintervention using validated tools to assess EI, parenting stress, psychological well-being and other mental health outcomes. Implementation will be evaluated using mixed methods to assess feasibility, acceptability and fidelity. Cost-effectiveness will be determined through a cost–utility analysis of direct and indirect costs.

Ethical approval was granted by the Institutional Review Board of Bangladesh Medical University (BSMMU/2022/10733). Written informed consent will be obtained at each stage of data collection and intervention. Findings will be disseminated through open-access publications, plain-language summaries, academic conferences, community workshops and policy briefs. Data will be shared in open-access platforms to inform mental health strategies in low-resource settings globally.

NCT06166550.

This study analysed the clinical outcomes and healthcare costs associated with diabetic foot ulcer (DFU) within a tertiary healthcare centre in Singapore.

This is a retrospective, single-centre study. Patient data were extracted from the hospital’s electronic health system, including demographic, clinical and hospitalisation information. Hospitalisation costs were categorised into DFU-related and other hospitalisation costs. A one-way sensitivity analysis was performed to estimate the total healthcare costs associated with DFU.

Tertiary centre within a population suffering from a diabetic epidemic.

All patients aged 18 years or older who received DFU treatment between January 2019 and December 2023 at the Singapore General Hospital were included.

A total of 2857 DFU patients were included in the study. In-hospital mortality remained stable at 5%–6% annually. Among the cohort, 39.1% underwent minor amputations, 19.6% had major amputations and 9.0% experienced both minor and major amputations. The median length of stay for surgical patients ranged from 10 (IQR 4–24) to 13 days (IQR 6–31), compared with 4 (IQR 2–8) to 5 (IQR 3–9.5) days for non-surgical patients. Total costs per admission for patients with DFU-related surgery ranged from US$28 588.96 to US$34 204.77, while for those without surgery, costs ranged from US$6637.59 to US$7955.23. Total hospitalisation costs for DFU during the study period ranged from US$65.87 million to US$72.16 million. All figures were inflation adjusted to 2023 US dollars.

DFU poses a significant clinical and economic burden in Singapore. Understanding the costs associated with DFU is essential for resource allocation and planning in DFU management.

Surgery represents the cornerstone for the treatment of several benign and malignant oesophageal disorders. Yet synthesising the growing body of evidence from clinical research is becoming increasingly challenging. Evidence mapping with living systematic reviews (SRs) and living meta-analyses offers a structured, continuously updated approach to navigating emerging data. This study aims to provide a real-time, interactive resource to support evidence-based decision-making for oesophageal surgery.

This study follows PRISMA guidelines and uses the EVIglance Studio web application to develop a living evidence map in oesophageal surgery. A systematic literature search will be conducted across the Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science and MEDLINE (PubMed) to identify randomised controlled trials (RCTs) and SRs related to oesophageal surgery, without any date or language restrictions. Study selection and data extraction will be performed independently by two reviewers. Key clinical and surgical outcomes, including morbidity, mortality, quality of life and oncological endpoints, will be extracted. Risk of bias in RCTs will be assessed using the Cochrane Risk of Bias 2.0 tool, and the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) system will be applied to evaluate the certainty of evidence. If at least three randomised trials address the same research question, a living meta-analysis will be conducted using random-effects models. The evidence map will be updated at least every 6 months.

This study does not involve individual patient data or any private information. Therefore, ethical approval is not required. As it uses only publicly available data, this study design qualifies as exempt from institutional review. The resulting evidence map is designed to support fast and structured access to high-quality surgical data - an approach not yet available in oesophageal surgery. The tool is expected to aid patients, clinicians and researchers alike by improving access to reliable information, supporting clinical decision-making and highlighting gaps in current evidence. On completion, results will be published in an open-access format and made permanently accessible via www.evidencemap.surgery, with continuous updates.

CRD420251022736 (https://www.crd.york.ac.uk/prospero/)

Communication is a professional competence that all paediatric healthcare professionals must learn and maintain to provide age and developmentally appropriate care. Child-centred communication encourages direct communication with children and adolescents, incorporating the use of play as a communicative strategy. Still, many paediatric healthcare professionals receive little or no formal training in communication and play. A critical barrier to communication training is the limited possibilities for healthcare professionals to take time from their clinical duties. Moreover, few randomised controlled trials have evaluated educational programmes on communication and play for paediatric healthcare professionals, and existing programmes vary significantly in design and duration. This study aims to compare the effects of a 45-min and a 3-hour educational intervention for healthcare professionals on age-appropriate communication and the use of play in clinical paediatric practice.

We will describe a single-centre, randomised, controlled, two-arm, non-inferiority trial. We will recruit 150 healthcare professionals with different professional backgrounds who will be randomised to one of two arms: a 45-min or 3-hour educational intervention on communication and play in paediatric clinical practice. The primary outcome will be their self-efficacy in patient-centredness at 12-week post-intervention, while secondary outcomes will be self-efficacy immediately after the intervention, motivation to engage in the educational activity, cognitive load, self-evaluated knowledge, satisfaction and the impact on individual practice and training needs. Data will be collected through questionnaires at baseline, immediately after the intervention, and 12 weeks post-intervention and will be analysed using linear mixed models with random effects to account for clustering and within-subject correlation.

The Danish Data Protection Agency approved the study (P-2020–1144), which will be conducted in accordance with the Declaration of Helsinki. Findings will be published in a peer-reviewed open-access scientific journal and presented at international conferences.

NCT06859632 (ClinicalTrials.gov).

The rising burden of non-communicable diseases (NCDs), including mental health disorders (MHDs) such as anxiety and depression, poses a significant public health challenge globally. Evidence suggests that both diabetes and hypertension, the two most prevalent NCDs, are linked to a higher prevalence of MHDs. However, there is a lack of evidence on prevalence of generalised anxiety disorder (GAD) and depression among adults living with both diabetes and hypertension in Bangladesh. We aimed to assess the prevalence of GAD and depression and explore the associated factors among adults living with diabetes and hypertension comorbidity in rural Bangladesh.

We implemented a cross-sectional study.

The study was conducted in Chirirbandar, a sub-district of Dinajpur, Bangladesh.

We interviewed a total of 387 adults living with diabetes and hypertension comorbidity.

We had two primary outcome measures: GAD and depression. Individuals scoring ≥10 on the General Anxiety Disorder-7 scale were considered as having GAD and individuals scoring ≥10 on the Patient Health Questionnaire-9 scale were considered as having depression. The outcome variables were dichotomised based on these scores.

The prevalence of GAD was 7.24% (95% CI 5.04 to 10.29). Education level (grades 5–9) (adjusted OR (AOR): 3.40, 95% CI 1.26 to 9.19) and household wealth status (highest wealth tertile) (AOR: 0.12, 95% CI 0.02 to 0.62) were associated with GAD. The prevalence of depression was 17.83% (95% CI 14.32 to 21.98). Socioeconomic factors associated with depression included unemployment (AOR: 3.26, 95% CI 1.05 to 10.10) and household wealth status (highest wealth tertile) (AOR: 0.45, 95% CI 0.21 to 0.98). Higher odds of depression were also observed among participants with controlled hypertension (AOR: 3.88, 95% CI 1.81 to 8.35). Other factors, such as tobacco use, dietary diversity and physical activity, were not associated with GAD or depression.

A high prevalence of GAD and depression was observed among adults living with diabetes and hypertension comorbidity. The findings from the study emphasise the need for integration of mental health services into the existing non-communicable disease care. The identified factors associated with GAD or depression should be considered to develop targeted interventions for people with hypertension and diabetes comorbidity in Bangladesh.

Palmoplantar pustulosis (PPP) is a rare, debilitating inflammatory skin disease involving painful pustules on the palms and soles. Janus kinase (JAK) inhibitors target pathways relevant to PPP disease biology but also confer a risk of major adverse cardiovascular events and malignancy in certain ‘at risk’ individuals; this includes those with PPP given prevalent smoking and cardiovascular risk factors in the PPP population. The feasibility of JAK inhibitor therapy for PPP requires assessment prior to a randomised controlled trial evaluation of drug efficacy and safety for this indication.

The ‘Janus kinase inhibitors in palmoplantar pustulosis: a mixed-methods feasibility’ trial is an open-label, single-centre, single-arm, mixed-methods feasibility trial of JAK inhibition in PPP (REC reference: 24/NE/0147; ISRCTN61751241). Participants (n=20) will receive 8 weeks of treatment with the JAK inhibitor upadacitinib (‘Rinvoq’, 30 mg, once daily). Qualitative semistructured interviews (up to n=40) will be undertaken with trial participants, trial decliners and healthcare professionals. The primary outcome will be a composite assessment of feasibility across three domains: recruitment, adherence and acceptability, using a mixed-methods analysis approach. Secondary objectives include the identification of trial recruitment optimisation strategies, using the ‘Quintet Recruitment Intervention’, and the generation of an indication of effect size on disease severity (measured using the Palmoplantar Pustulosis Psoriasis Area and Severity Index) to inform future sample size calculations. Historic placebo control data from the Anakinra for Pustular Psoriasis: Response in a Controlled Trial (National Institute of Health and Social Care reference: 13/50/17; Research Ethics Commitee reference: 16/LO/0436) will be used as the effect size comparator. Study recruitment will be undertaken over a 24-month period, commencing in November 2024.

This study has been approved by the Newcastle North Tyneside 2 Research Ethics Committee, 24/NE/0132. Our findings will inform the feasibility of a future adequately powered RCT evaluating the efficacy of JAK inhibitor therapy in PPP.

ISRCTN61751241.

This study aimed to investigate the relationship between coping strategies and compassion fatigue among healthcare professionals in Central Uganda.

A facility-based cross-sectional study conducted between June and July 2023. Three tools were used for data collection: a socio-demographic survey, the Professional Quality of Life Scale (ProQOL-5) and the Brief-Coping, Orientation to Problem Experienced tool. Participants were asked to recall experiences from the previous 30 days.

The study was conducted in five prominent hospitals in Central Uganda.

A total of 548 healthcare providers, including 191 physicians, 256 nurses and 103 technicians.

Compassion fatigue scores.

Most participants were under 29 years old (50.9%) and women (62.0%). High levels of compassion fatigue were reported by 37.8% of participants. Active coping, self-distraction and denial were associated with higher compassion fatigue, while informational support, positive reframing and venting were linked to lower fatigue levels. Seeking social support effectively reduced compassion fatigue.

The findings highlight significant compassion fatigue among healthcare providers in Central Uganda, impacting their well-being and patient care. Coping strategies like active problem-solving and social support are promising in mitigating compassion fatigue. Interventions should focus on reducing self-distraction, enhancing problem-solving skills and fostering supportive work environments to improve healthcare workers’ well-being and patient care quality.

Rare diseases (RD) are collectively common and often genetic. Families value and can benefit from precise molecular diagnoses. Prolonged diagnostic odysseys exacerbate the burden of RD on patients, families and the healthcare system. Genome sequencing (GS) is a near-comprehensive test for genetic RD, but existing care models—where consultation with a medical geneticist is a prerequisite for testing—predate GS and may limit access or delay diagnosis. Evidence is needed to guide the optimal positioning of GS in care pathways. While initiating GS prior to geneticist consultation has been trialled in acute care settings, there are no data to inform the utility of this approach in outpatient care, where most patients with RD seek genetics services. We aim to evaluate the diagnostic yield, time to diagnosis, clinical and personal utility and incremental cost-effectiveness of GS initiated at the time of referral triage (pre-geneticist evaluation) compared with standard of care.

200 paediatric patients referred to one of two large genetics centres in Ontario, Canada, for suspected genetic RD will be randomised into a 1:1 ratio to the intervention (GS first) or standard of care (geneticist first) arm. An unblinded, permuted block randomisation design will be used, stratified within each recruitment site by phenotype and prior genetic testing. The primary outcome measure is time to genetic diagnosis or to cessation of active follow-up. Survival analysis will be used to analyse time-to-event data. Additional measures will include patient-reported and family-reported measures of satisfaction, understanding and perceived test utility, clinician-reported measures of perceived test utility and management impact, and healthcare system utilisation and costs.

This study was approved by Clinical Trials Ontario. Results will be disseminated, at minimum, via peer-reviewed journals, professional conferences and internal reports to funding bodies. Efforts will be made to share aggregated study results with participants and their families.

NCT06935019.

Prostate cancer (PCa) is the second most common cancer in men worldwide and genetic factors and family history significantly increase the risk of PCa. Men at increased risk for PCa often experience higher PCa-specific anxiety and distress. Comprehensive prevention strategies for men with familial or genetic PCa predisposition are lacking. Consequently, the psychological impact, facilitators and barriers for risk-adapted PCa prevention lack comprehensive study. The novel prospective registry and prevention clinic ‘ProFam-Risk’ (prevention clinic for familial PCa risk) at the University Hospital Düsseldorf offers personalised risk assessment and risk-adapted prevention recommendations for men with familial or genetic PCa predisposition. As part of this research project, this study (‘ProFam-Psych’ - risk-adapted prevention clinic for familial and genetic prostate cancer: psychosocial effects; funded by German Cancer Aid) aims to evaluate the longitudinal psychosocial trajectories associated with this novel prevention clinic.

In a longitudinal observational mixed-methods design, psychosocial outcomes will be assessed in participants of the prevention clinic (case group, CAG) and compared with urology patients without increased risk for PCa (control group, COG). Psychosocial outcomes will be collected at four time points in the CAG (T0: baseline; T1: after first visit; T2: after risk stratification consultation; T3: follow-up 6 months after T2) and at two time points in the COG (T0: baseline during inpatient stay; T1: post-inpatient stay). Recruitment started in 2023, and the recruitment target is n=225 participants (CAG) and n=118 participants (COG). Primary endpoint is the longitudinal course of PCa-specific anxiety (Memorial Anxiety Questionnaire for Prostate Cancer) in the CAG. Secondary endpoints include the comparison of T0 and T1 outcomes between the CAG and COG and the assessment of changes in perceived PCa risk and perceived personal control in the CAG. To assess facilitators and barriers to participation in the risk-adapted PCa prevention clinic, a minimum of n=12 semi-structured qualitative interviews will be conducted, with recruitment continuing until data saturation is reached. Qualitative data will be analysed using qualitative content analysis.

Ethics approval from the Medical Faculty of the Heinrich Heine University Düsseldorf was obtained (2023-2551). Results of the main objective and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal.

DRKS.de, DRKS00032350. Prospectively registered with the German Clinical Trials Register (DRKS) on 14 September 2023.

Secondary and tertiary renal hyperparathyroidism (RHPT) are common sequelae of chronic kidney disease and are associated with worse patient mortality and quality of life. Clinical guidelines remain lacking with regard to recommendations for using intraoperative parathyroid hormone (IOPTH) during surgery for RHPT. A prospective randomised study will help evaluate the role of IOPTH in guiding surgery for secondary and tertiary RHPT.

Intraoperative parathyroid hormone monitoring to guide surgery in renal hyperparathyroidism is a pragmatic, multicentre, five-arm, parallel-group, patient-blinded and outcome assessor-blinded prospective pilot trial used to evaluate the feasibility of performing a definitive trial. Eligible participants include adult patients diagnosed with secondary or tertiary hyperparathyroidism who are candidates for subtotal or total parathyroidectomy. Consenting patients will be randomly assigned, through central allocation, in a 1:1:1:1:1 fashion to undergo surgery with IOPTH monitoring (four experimental arms: postexcision IOPTH samples taken at 10, 15, 20 or 25 min) or to undergo surgery without IOPTH monitoring (control arm). The primary feasibility objective is to estimate the percentage of eligible patients that are randomised: ≥70% proceed; 50–69% modify protocol before proceeding;

Ethics approval was obtained from the Hamilton Integrated Research Ethics Board. Pilot trial results will be shared widely through local, national and international academic and clinical networks and will be disseminated through conference presentations and publication in peer-reviewed journals.

NCT06542315, registered on 6 August 2024.

Osteoporosis is a skeletal condition with decreased bone mass and structural deterioration, increasing fracture vulnerability. Several studies have found a correlation between prostate cancer in men and an increased risk of osteoporosis. This study aims to determine the prevalence of osteoporosis in patients with prostate cancer.

The primary objective of this study will be to estimate the prevalence of osteoporosis in prostate cancer survivor patients. An extensive search will be conducted on PubMed, Scopus, Embase, Web of Science, CINAHL and ProQuest databases to ensure comprehensive coverage. The search will encompass the timeframe from 1 January 1994 to 24 September 2024. Furthermore, we will not impose any limitations on the language or geographical location of the published studies. In order to assess the potential bias in the included studies, the Joanna Briggs Institute critical appraisal checklist for prevalence studies will be employed. The analysis of data will be performed using STATA V.17. The prevalence of osteoporosis or osteopenia will be calculated for each study by dividing the number of participants with these conditions by the total number of patients diagnosed with prostate cancer. A subgroup analysis will examine prevalence regarding geographical location, age groups, ethnicity, definitions and measurements of osteoporosis or osteopenia, risk of bias in the included studies, type and duration of androgen deprivation therapy, and site of osteoporosis diagnosis. We will employ multiple methods to detect publication bias, including funnel plot analysis, Begg’s and Egger’s tests, and the Trim and Fill method. If we have enough data, we will conduct a sensitivity analysis using the leave-one-out-remove method.

No ethical approval or patient consent is required as this study synthesises only published aggregate data. Results will be disseminated via a peer-reviewed publication.

CRD42024600884.

Neoadjuvant (chemo)radiotherapy (n(C)RT) followed by resection with total mesorectal excision (TME) constitutes the standard treatment for patients with locally advanced rectal cancer of the middle and lower third. However, n(C)RT has demonstrated no significant impact on overall survival but is associated with adverse effects, including impaired sphincter and sexual function. We hypothesise that omitting n(C)RT in selected patients with a clear circumferential resection margin (CRM) >1 mm as determined through preoperative MRI is not inferior regarding local recurrence rate within 3 years after surgery. That treatment approach may show fewer adverse effects and be more cost-effective.

Selective neoadjuvant therapy of rectal cancer patients (SELREC) is a randomised controlled, parallel-group, open, multicentre, non-inferiority trial. The experimental intervention involves performing TME surgery without n(C)RT. In contrast, the control intervention adheres to German S3-guidelines, incorporating neoadjuvant radiotherapy (nRT) with a dosage of 5x5 Gy or a total of 50.4 Gy. Additionally, if applicable, concomitant chemotherapy (CT) based on 5-fluorouracil is administered, followed by TME surgery within less than 12 weeks. Adjuvant treatment according to guidelines is allowed depending on the (y)pTNM stage.

The inclusion criteria for this study encompass adult patients with primary adenocarcinoma of the rectum in whom the main tumour mass is located less than 12 cm away from the anal verge, as assessed via proctoscopy. Additionally, eligible participants are required to have a preoperative tumour stage determined by MRI of either T1 or T2 with lymph node involvement (N1) or T3 with no lymph node involvement (N0) or with lymph node involvement (N1) and no distant metastases (M0). The assessment of a clear CRM >1 mm, based on MRI, is another prerequisite for inclusion. A total of 1074 patients in approximately 35 centres are planned to be allocated to the trial.

The primary endpoint of the trial is local recurrence within 3 years after surgery. The primary estimand is based on the full analysis set using a logistic mixed model (margin 3%). The first secondary endpoint is no/minor low anterior resection syndrome (LARS) score at 2 years after surgery, and further secondary endpoints include survival outcomes and quality of life. Safety analysis involves describing the frequencies of major intervention-specific complications, such as the acute toxicity of n(C)RT according to CTCAE and perioperative morbidity and mortality according to Clavien-Dindo criteria.

SELREC is financially supported by the German Federal Ministry of Education and Research.

This trial has been prospectively registered in the German Clinical Trials Register.

Previously, the study had been approved by the responsible ethics committee of Heidelberg and the local ethics committees of the collaborating institutions before patient enrolment. Any protocol deviation that has an impact on relevant parameters such as study design, endpoints or patient safety will be reported to the responsible ethics committees.

The results will be published in a peer-reviewed scientific journal and on institutional websites.

German Clinical Trials Register DRKS00030567.

Diabetes is one of the most common long-term health conditions worldwide, placing a huge economic burden on health services. Diabetes self-management education and support programmes can support people with diabetes to manage their condition; however, uptake of face-to-face services remains low. Digital self-management tools are becoming increasingly available. MyWay Diabetes is a digital platform that offers a comprehensive self-management and education programme accessible through a mobile app and website and allows patients to access their personal healthcare records. Following successful implementation in Scotland, MyWay Diabetes is now being rolled out in three geographical areas in England. We plan to undertake three qualitative studies, as part of a larger mixed-methods research programme, to assess whether MyWay Diabetes is acceptable across diverse patient groups and healthcare professionals and gather views of patients who do not currently use the digital service.

We will conduct three online focus group studies. (1) One focus group with healthcare professionals (n=6–10) to understand their perceptions of implementing MyWay Diabetes in their local regions. (2) Up to four focus groups with existing users of MyWay Diabetes (n=24–40) across the three geographical areas in England to explore their acceptability of the platform. (3) Up to three focus groups with people living with diabetes who do not currently use MyWay Diabetes (n=18–30). Data will be collected using online videoconferencing and analysed thematically using template analysis.

Ethical approval was granted by South Central – Berkshire Research Ethics Committee (ref: 25/SC/0125) and The University of Manchester Proportionate Research Ethics Committee (ref: 2025-23064-42006). Study results will be disseminated through peer-reviewed journals, conference presentations, MyWay Digital Health platforms and national bodies. The evidence from this broader mixed-methods evaluation will inform decisions for platform improvement and regional and national commissioning across the National Health Service in England.

The New York City (NYC) HIV Care Coordination Programme (CCP) is designed to help people with HIV (PWH) overcome barriers to care and treatment engagement. We assessed preferences for CCP components among programme enrollees (’clients’) and providers. Our objective is to compare client and provider preferences, which were previously analysed separately.

We used a discrete choice experiment to assess preferences for four CCP features (‘attributes’): Help with Adherence to Antiretroviral Therapy (ART), Help with Primary Care Appointments, Help with Issues other than Primary Care and Where Programme Visits Happen. Each of these attributes had 3–4 variants (‘levels’). In the original surveys, levels within Where Programme Visits Happen varied by participant type (client vs provider). We recoded the levels by visit location (VL) or by travel time (TT) to make them comparable and report results from both approaches.

25 Ryan White Part A-funded NYC CCPs participated.

152 providers and 181 clients completed the survey.

Preferences were quantified using the relative importance of the attributes and utility of the levels.

From January 2020 to March 2021, 152 providers and 181 clients completed the survey. Most of the providers (52%) were

Client and provider preferences clearly diverged regarding CCP service intensity: in the aggregate, clients tended to prefer lower-intensity services, whereas providers endorsed higher-intensity services. These results highlight the importance of engaging clients as partners in decisions about programme services to facilitate alignment with client values.

The combination of a reduction in the Danish hospital bed count, the shortage of hospital staff and demographic changes challenges the Danish hospital capacity. This was further highlighted during the COVID-19 pandemic when hospitals worldwide were overwhelmed by infected patients requiring acute hospital care. To address these challenges, a hospital-at-home (HaH) programme offers an alternative to conventional in-hospital admission. Furthermore, HaH has the potential to improve patient outcomes, reduce costs and increase patient satisfaction. However, few studies have evaluated HaH in a Scandinavian setting, and this article describes the protocol for a randomised controlled trial (RCT) comparing an HaH model with continued conventional in-hospital admission. The main aim of the trial is to evaluate physical activity level and mental wellbeing in patients admitted at home compared with conventionally admitted patients.

110 clinically stable patients from two internal medical wards at Nordsjaellands Hospital in Denmark will be included and randomised in a ratio of 1:1 to either continued conventional in-hospital admission (control group) or virtual HaH model (intervention group). The control group will receive standard hospital treatment, and the intervention group will be transferred home for continued treatment (eg, intravenous antibiotics or oxygen treatment). The primary outcome measures are physical activity assessed using daily step count (during the first 24 hours after inclusion, as an intermediary indicator of the risk of adverse events) and treatment satisfaction (assessed using a patient satisfaction survey). Secondary outcome measures are adverse events of special interest, escalation of care, readmission rate postdischarge (30 days and 90 days), mortality (associated and 7 days, 30 days and 90 days postdischarge), process data (eg, the number of teleconsultations) and a health economic evaluation.

The study was approved by the Danish Research Ethics Committees (no. 2303051) and the Danish Medicines Agency (CIV-23-03-042542) and will be monitored by the Copenhagen University Hospital Good Clinical Practice unit. Results will be published in peer-reviewed journals and presented at relevant national and international conferences. We also plan to communicate the results to relevant stakeholders in the Danish healthcare system.

NCT05920304.