Maintaining independence in individuals with dementia at home after a fall: a protocol for the UK pilot cluster randomised controlled trial MAINTAIN

\ua9 Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.Introduction Individuals with dementia face an increased risk of falls. Falls can cause a decline in the individual\u27s overall functionality. All types of falls, including those that do not result in injury, can lead to psychosocial consequences, such as diminished confidence and a fear of falling. Projections indicate a rising trend in dementia diagnoses, implying an increase in fall incidents. Yet, there is a lack of evidence to support interventions for people living with dementia who have fallen. Our objective is to test the feasibility of a falls intervention trial for people with dementia. Method and analysis This is a UK-based two-arm pilot cluster randomised controlled trial. In this study, six collaborating sites, which form the clusters, will be randomly allocated to either the intervention arm or the control arm (receiving treatment as usual) at a 1:1 ratio. During the 6 month recruitment phase, each cluster will enrol 10 dyads, comprising 10 individuals with dementia and their respective carers, leading to a total sample size of 60 dyads. The primary outcomes are the feasibility parameters for a full trial (ie, percentage consented, follow-up rate and cost framework). Secondary outcomes include activities of daily living, quality of life, fall efficacy, mobility, goal attainment, cognitive status, occurrence of falls, carer burden and healthcare service utilisation. Outcome measures will be collected at baseline and 28 weeks, with an additional assessment scheduled at 12 weeks for the healthcare service utilisation questionnaire. An embedded process evaluation, consisting of interviews and observations with participants and healthcare professionals, will explore how the intervention operates and the fidelity of study processes. Ethics and dissemination The study was approved by the NHS and local authority research governance and research ethics committees (NHS REC reference: 23/WA/0126). The results will be shared at meetings and conferences and will be published in peer-reviewed journals. Trial registration number ISRCTN16413728

Designing a Single Online Screening and eConsenting System to Maximise Recruitment for Three Concurrent Randomised Controlled Trials of Complex Interventions for Improving Student Mental Health

The aim of the NURTURE-U study is to develop and evaluate an acceptable, effective, cohesive system of whole-university and stepped care student wellbeing and mental health support. This study comprises three concurrent randomised controlled trials (RCTs) which will evaluate different approaches of support. Participants will be allocated to a trial based on their screening assessment. Screening, consenting and data collection is to be conducted online in the form of surveys. A key requirement of the solution is participants’ user experience of the enrolment process (screening and consenting). The participants’ journey, from screening to baseline completion, should be perceived as a single survey whilst accommodating segregation of trial data. A system or integrated systems to facilitate this had to be developed. The defined process allows individuals to enter the screening survey, consent and complete screening before being, automatically, evaluated for trial eligibility. There are four possible outcomes from the study screening. If an individual consents to participate in a trial, they then continue to complete the baseline survey for their allocated trial. REDCap Academic (RCA) was selected as the solution system, due to its versatility as an EDC system with survey capabilities and extensive API. Desired features include RCA’s ability to prepopulate (pipe) data from one survey to another, allowing participants to be seamlessly transferred into an alternative project within RCA whilst completing a survey. Four RCA validated projects were created: one screening and one for each of the three trials. Once participants complete enrolment for a trial, they are automatically transferred to the trial’s baseline survey without any break in survey flow. This transfer includes piped data, such as screening ID, linking the screening record to the trial record. User Acceptance Testing by the study team and students will conclude in August 2022, providing feedback on student engagement of the system design and user experience, prior to deployment in Autumn 2022. A single, unified, online screening and consenting system to determine eligibility against multiple trials is an efficient trial enrolment solution. By negating the need for potential participants to complete multiple screening surveys for different concurrent trials, it is anticipated that the system will aid recruitment, as well as reducing burden on both potential participants and trial teams.Medical Research Council (MRC