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.

Malaria remains a major public health challenge in India, with transmission dynamics varying widely across ecological, epidemiological, sociobehavioural and health system contexts. Achieving the national malaria elimination target by 2030 requires integrated, context-specific evidence to design effective interventions. This study aims to generate a comprehensive understanding of malaria transmission and factors surrounding it across diverse eco-epidemiological settings in India by assessing malaria burden, identifying determinants of transmission, evaluating health system performance and equity, characterising vector bionomics and insecticide resistance, and examining the influence of environmental drivers.

This longitudinal, multicentric study will be conducted in collaboration with the national programme in 12 districts spanning 10 states in India, covering a population of around 25 000 individuals representing varied ecological contexts (urban, periurban, rural, forest-foothill and coastal) and malaria endemicity levels. In each district, two clusters (villages) with a population of 1000 individuals will be included. A baseline mass survey will estimate malaria prevalence using bivalent rapid diagnostic tests (RDTs) and blood smear microscopy, with low-density parasitaemia detected by PCR in a subset of RDT-negative samples. Participants will be followed for 1 year, with monthly screening of symptomatic individuals using RDT and microscopy, and testing a subset of asymptomatic individuals to detect subclinical infections. Sociobehavioural data will be collected through structured interviews and household observations, with purposive inclusion of vulnerable groups, pregnant women, migrants, elderly persons, individuals with disabilities and tribal populations to assess equity dimensions through mixed-methods approaches. Health system performance will be evaluated through key informant interviews with programme officials, health workers, patients, private practitioners and traditional healers. Entomological surveillance will document vector species composition, density, infection rates and assessment of susceptibility status and intensity of insecticide resistance to commonly used public health insecticides. Environmental variables, including temperature, rainfall and humidity, will be linked with entomological and epidemiological data to explore spatiotemporal relationships.

The protocol was approved by the Institute Human Ethics Committee of ICMR-Vector Control Research Centre (IHEC 03-0125/N/F). All standard ethical practices will be adhered to. The findings will be shared with stakeholders and published in reputed open-access journals.

Pelvic floor muscle (PFM) training (PFMT) is a standard conservative first-line treatment for stress urinary incontinence (SUI) in women. However, the success of PFMT alone, without adjunctive therapies, has been hindered by the lack of adherence among women, who report the inability to contract the correct PFMs and limited motivation to perform PFMT exercises. Therefore, PFMT is often combined with adjunctive therapies, such as biofeedback (BF). The conventional BF device employed in clinical practice is invasive and involves the insertion of an intravaginal probe, causing pain or discomfort for women. Therefore, our team developed the PelviSense, a non-invasive BF device for use as a PFMT adjunct. The proposed randomised controlled trial (RCT) aims to (1) investigate the efficacy of PelviSense-assisted PFMT compared with unassisted PFMT in reducing SUI in women, and (2) identify the mechanisms underlying the beneficial effects of PelviSense-assisted PFMT for the treatment of SUI.

A prospective, two-arm, parallel-group RCT will be conducted. It will involve 132 women aged 18–60 years with SUI or stress-predominant mixed urinary incontinence, who will be randomised into PelviSense-assisted (n=66) or unassisted (n=66) PFMT groups using a computer-generated randomisation schedule. Supervised PelviSense-assisted and unassisted PFMT will be provided on a one-to-one basis for 30 min, three times per week, for 4 weeks. Following the supervised training period, participants will perform the exercises at home unsupervised for 24 weeks, with or without the PelviSense device, according to their assigned group. The primary outcome will be the severity of urine loss, measured using the 1-hour pad test. The secondary outcomes will be the severity of SUI symptoms, measured using the International Consultation on Incontinence Questionnaire-Short Form, and quality of life, measured using the Incontinence Impact Questionnaire-Short Form. The mediating outcomes will include PFM strength, measured using the Modified Oxford scale, as well as levator hiatus area and bladder neck position, measured by transperineal ultrasound. The outcomes will be assessed at baseline (week 0), postintervention (week 4) and at follow-up (week 28).

This RCT has received ethical approval from the Institutional Review Board of The Hong Kong Polytechnic University (approval number: HSEARS20211104002-02). Its findings will be disseminated to participants via written feedback on PFMT performance using the PelviSense device, to the general public via public lectures, to healthcare professionals via interactive workshops and to researchers via articles in peer-reviewed journals and presentations at national and international conferences.

NCT06126757.