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

Por: Greene · L. · Barber · R. · Bingham · A. · Connors · J. · Conroy · S. · Elkhafer · K. · Fox · C. · Goodwin · V. · Gordon · A. · Hall · A. J. · Harwood · R. H. · Hulme · C. · Jackson · T. · Litherland · R. · Morgan-Trimmer · S. · Pankiewicz · S. · Parry · S. W. · Sharma · A. · Ukoumunne · O.
Introduction

Individuals with dementia face an increased risk of falls. Falls can cause a decline in the individual’s 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.

Clinical and cost-effectiveness of DREAMS START (Dementia RElAted Manual for Sleep; STrAtegies for RelaTives) for people living with dementia and their carers: a study protocol for a parallel multicentre randomised controlled trial

Por: Rapaport · P. · Amador · S. · Adeleke · M. · Banerjee · S. · Barber · J. · Charlesworth · G. · Clarke · C. · Connell · C. · Espie · C. · Gonzalez · L. · Horsley · R. · Hunter · R. · Kyle · S. D. · Manela · M. · Morris · S. · Pikett · L. · Raczek · M. · Thornton · E. · Walker · Z. · Webster
Introduction

Many people living with dementia experience sleep disturbance and there are no known effective treatments. Non-pharmacological treatment options should be the first-line sleep management. For family carers, relatives’ sleep disturbance leads to interruption of their sleep, low mood and breakdown of care. Our team developed and delivered DREAMS START (Dementia RElAted Manual for Sleep; STrAtegies for RelaTives), a multimodal non-pharmacological intervention, showing it to be feasible and acceptable. The aim of this randomised controlled trial is to establish whether DREAMS START is clinically cost-effective in reducing sleep disturbances in people living with dementia living at home compared with usual care.

Methods and analysis

We will recruit 370 participant dyads (people living with dementia and family carers) from memory services, community mental health teams and the Join Dementia Research Website in England. Those meeting inclusion criteria will be randomised (1:1) either to DREAMS START or to usual treatment. DREAMS START is a six-session (1 hour/session), manualised intervention delivered every 1–2 weeks by supervised, non-clinically trained graduates. Outcomes will be collected at baseline, 4 months and 8 months with the primary outcome being the Sleep Disorders Inventory score at 8 months. Secondary outcomes for the person with dementia (all proxy) include quality of life, daytime sleepiness, neuropsychiatric symptoms and cost-effectiveness. Secondary outcomes for the family carer include quality of life, sleep disturbance, mood, burden and service use and caring/work activity. Analyses will be intention-to-treat and we will conduct a process evaluation.

Ethics and dissemination

London—Camden & Kings Cross Ethics Committee (20/LO/0894) approved the study. We will disseminate our findings in high-impact peer-reviewed journals and at national and international conferences. This research has the potential to improve sleep and quality of life for people living with dementia and their carers, in a feasible and scalable intervention.

Trial registration number

ISRCTN13072268.

Prototyping Process and Usability Testing of a Serious Game for Brazilian Children With Type 1 Diabetes

imageThis study aims to describe the prototype development and testing of a serious game designed for Brazilian children with diabetes. Following an approach of user-centered design, the researchers assessed game's preferences and diabetes learning needs to develop a Paper Prototype. The gameplay strategies included diabetes pathophysiology, self-care tasks, glycemic management, and food group learning. Diabetes and technology experts (n = 12) tested the prototype during audio-recorded sessions. Next, they answered a survey to evaluate the content, organization, presentation, and educational game aspects. The prototype showed a high content validity ratio (0.80), with three items not achieving the critical values (0.66). Experts recommended improving the game content and food illustrations. This evaluation contributed to the medium-fidelity prototype version, which after testing with diabetes experts (n = 12) achieved high content validity values (0.88). One item did not meet the critical values. Experts suggested increasing the options of outdoor activities and meals. Researchers also observed and video-recorded children with diabetes (n = 5) playing the game with satisfactory interaction. They considered the game enjoyable. The interdisciplinary team plays an important role guiding the designers in the use of theories and real needs of children. Prototypes are a low-cost usability and a successful method for evaluating games.

10 recomendaciones para diseñar un plan virtual de inmersión en enfermería

La elevada rotación del personal de enfermería que se produce en todos los centros sanitarios públicos y privados de nuestro país es una realidad muy habitual de nuestros días. La formación inicial de las nuevas compañeras plantea una dificultad añadida a la sobrecarga de trabajo que se da en muchos destinos. Con las nuevas tecnologías, tenemos en las formaciones online una gran oportunidad para diseñar planes de inmersión con un formato virtual.

Efectividad de una intervención enfermera de información, sobre el nivel de ansiedad del familiar del paciente quirúrgico programado

Objetivo principal: Analizar si una intervención de enfermería de información sobre la cirugía y el circuito quirúrgico, tendría como efecto la disminución del nivel de ansiedad en el familiar del paciente quirúrgico programado. Metodología: Ensayo clínico controlado no aleatorizado. Se efectúa la comparación del nivel de ansiedad entre los familiares pertenecientes al grupo control (con intervención estándar preexistente) respecto a los del grupo intervención (sometidos a la nueva intervención de enfermería). Se utiliza un instrumento validado como el inventario de ansiedad estado-rasgo (STAI) para medir el nivel de ansiedad. Resultados principales: Participaron en el estudio 76 familiares, 37 en el grupo control y 39 en el grupo intervención. Ambos grupos eran comparables respecto a sus características basales. Se observa una disminución estadísticamente significativa en la ansiedad situacional durante el postoperatorio en el grupo intervención respecto al grupo control. Conclusión principal: Una intervención de enfermería de información sobre la cirugía y el circuito quirúrgico reduce la ansiedad situacional del familiar del paciente quirúrgico programado.

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