Stroke is one of the top causes of disability in Malaysia, yet caregivers have limited access to structured, culturally tailored education to support poststroke care.

To develop and validate the CaknaStrok Education Package (CEP), a blended learning intervention comprising a printed guidebook and a trilingual mobile health application for informal stroke caregivers in Malaysia.

Methodological study involving the development and validation of a caregiver education programme guided by the Analyse, Design, Develop, Implement, Evaluate (ADDIE) instructional design framework.

Development and validation were conducted in Malaysia between January 2022 and December 2023. Both experts and caregivers were recruited from two tertiary hospitals on the East Coast of Malaysia, with caregivers identified from inpatient wards and outpatient clinics at these hospitals.

Content validation involved 10 multidisciplinary experts. Face validation involved 14 informal stroke caregivers who met eligibility criteria, and all completed the study.

CEP was developed based on prior needs assessment and expert input. Content validation was undertaken using the Content Validity Index (CVI) and face validation using the Face Validity Index (FVI), both assessed on a four-point Likert scale. Qualitative feedback was also obtained from the participants.

CEP consists of six modules delivered via a printed guidebook and a trilingual app with videos, assessment tools and local resources. Experts rated the content highly valid (Scale-level (S)-CVI/the average method (Ave): 0.97–0.99 across domains). Caregivers reported strong acceptability (S-FVI/Ave: 0.95–0.99). Qualitative feedback from experts and caregivers informed refinements to content clarity, usability and presentation, including improved navigation, consistent language use and enhanced visual design. Suggestions requiring substantial structural changes were documented for future iterations.

The CEP shows strong content and face validity as a blended caregiver education tool. By combining printed and digital formats, CEP addresses cultural and access challenges and provides a scalable model for stroke caregiver education in Malaysia. Further pilot or feasibility studies are warranted to evaluate usability, engagement and implementation in real-world settings prior to effectiveness evaluation.

Cardiovascular disease (CVD) is the leading cause of mortality in patients undergoing chronic haemodialysis (HD). However, relatively few data exist regarding the influence of dialysis treatment on cardiac biomarkers such as high-sensitivity cardiac troponin I and T (hs-cTnI and hs-cTnT) and N-terminal pro-B-type natriuretic peptide (NT-proBNP), complicating their interpretation in the diagnosis of acute coronary syndrome and heart failure. This study aims to investigate the intradialytic kinetics of hs-cTnT, hs-cTnI and NT-proBNP, during HD and haemodiafiltration (HDF), in patients treated with chronic HD.

Single-centre, randomised, open-label, crossover study, comparing high-flux HD (FX 100 dialyser) and postdilution HDF (FX 1000 dialyser), regarding their potential clearance of hs-cTnI, hs-cTnT and NT-proBNP, in 24 stable patients treated with in-centre HD without acute CVD. The study will investigate changes in concentrations during and after high-flux HD and postdilution HDF and calculate reduction ratios, dialyser clearance and clearance by adsorption to the membrane of the selected cardiac biomarkers. Blood samples will be collected at baseline, after 10, 30, 60, 120, 180 and 240 min of dialysis and 30 min postdialysis. After 120 min of dialysis, dialysate will also be collected from the dialyser outlet line. The primary outcome is change from baseline in concentrations of hs-cTnI, hs-cTnT and NT-proBNP during high-flux HD and postdilution HDF.

The study has been approved by the North Denmark Region Committee on Health Research Ethics (N-20240016). Results will be published in an international peer-reviewed journal and disseminated at national and international research meetings.

NCT06526702.

Cystic fibrosis-related diabetes (CFRD) is one of the most clinically impactful comorbidities associated with cystic fibrosis (CF). Current recommended management with insulin therapy is challenging due to variable daily insulin requirements and adds to the significant burden of self-management. This study aims to determine if hybrid closed-loop insulin delivery can improve glucose outcomes compared with standard insulin therapy with continuous glucose monitoring (CGM) in young people (≥16 years) and adults with CFRD.

This open-label, multicentre, randomised, two-arm, single-period parallel design study aims to randomise 114 young people (≥16 years) and adults with CFRD. Following a 2–3 weeks’ run-in period, during which time participants use a masked CGM, participants with time in target glucose range (3.9–10.0 mmol/L) 10.0 mmol/L), mean glucose and HbA1c. Other secondary efficacy outcomes include glucose and insulin metrics, change in forced expiratory volume in 1 s and body mass index. Safety, utility, participant experiences and participant-reported outcome measures will also be evaluated. The trial is funded by the National Institute for Health and Care Research.

Ethics approval has been obtained from East of England–Cambridge South Research Ethics Committee. Results will be disseminated by peer-reviewed publications and conference presentations, and findings will be shared with people living with CF, healthcare providers and relevant stakeholders.

NCT05562492.