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Adults with chronic kidney disease (CKD) experience a wide range of symptoms that significantly lower their health-related quality of life (HRQoL). Using mobile-based applications for symptom assessment and management has the potential to alleviate the symptom burden of CKD and improve patient outcomes.
This is a randomised feasibility trial to assess the feasibility, acceptability, usability and potential effects of a remote symptom assessment and management (SAM-CKD) 6 week programme delivered via a mobile application. Adults aged 18 years or older with CKD grade 4 or 5 (including those on dialysis) will be randomly assigned to the SAM-CKD programme or usual care. Primary outcomes assess the intervention’s feasibility, acceptability and usability. Secondary outcomes are changes in CKD symptoms and HRQoL between baseline, 3 weeks and 6 weeks later. Data analysis involves descriptive and intention-to-treat analyses. The study will be undertaken between December 2025 and March 2026. The findings will inform whether an effective trial is feasible and whether the study design and/or its methods need modification.
Ethical approval was granted by the Vin University and Griffith University Human Research Ethics Committee. Results will be disseminated at the participating hospital and CKD patient groups and shared via peer-reviewed publications and conference presentations.
Distal radius fractures are the most common fractures seen in the emergency department in children in the USA. However, no established or standardised guidelines exist for the optimal management of completely displaced fractures in younger children. The proposed multicentre randomised trial will compare functional outcomes between children treated with fracture reduction under sedation versus children treated with simple immobilisation.
Participants aged 4–10 years presenting to the emergency department with 100% dorsally translated metaphyseal fractures of the radius less than 5 cm from the distal radial physis will be recruited for the study. Those patients with open fractures, other ipsilateral arm fractures (excluding ulna), pathologic fractures, bone diseases, or neuromuscular or metabolic conditions will be excluded. Participants who agree to enrol in the trial will be randomly assigned via a minimal sufficient balance algorithm to either sedated reduction or in situ immobilisation. A sample size of 167 participants per arm will provide at least 90% power to detect a difference in the primary outcome of Patient-Reported Outcomes Measurement Information System Upper Extremity computer adaptive test scores of 4 points at 1 year from treatment. Primary analyses will employ a linear mixed model to estimate the treatment effect at 1 year. Secondary outcomes include additional measures of perceived pain, complications, radiographic angulation, satisfaction and additional procedures (revisions, refractures, reductions and reoperations).
Ethical approval was obtained from the following local Institutional Review Boards: Advarra, serving as the single Institutional Review Board, approved the study (Pro00062090) in April 2022. The Hospital for Sick Children (Toronto, ON, Canada) did not rely on Advarra and received separate approval from their local Research Ethics Board (REB; REB number: 1000079992) on 19 July 2023. Results will be disseminated through publication in peer-reviewed journals and presentations at international conference meetings.
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