A Smart Digital Health Platform to Enable Monitoring of Quality of Life and Frailty in Older Patients with Cancer: A Mixed-Methods, Feasibility Study Protocol.

OBJECTIVES: LifeChamps is an EU Horizon 2020 project that aims to create a digital platform to enable monitoring of health-related quality of life and frailty in patients with cancer over the age of 65. Our primary objective is to assess feasibility, usability, acceptability, fidelity, adherence, and safety parameters when implementing LifeChamps in routine cancer care. Secondary objectives involve evaluating preliminary signals of efficacy and cost-effectiveness indicators. DATA SOURCES: This will be a mixed-methods exploratory project, involving four study sites in Greece, Spain, Sweden, and the United Kingdom. The quantitative component of LifeChamps (single-group, pre-post feasibility study) will integrate digital technologies, home-based motion sensors, self-administered questionnaires, and the electronic health record to (1) enable multimodal, real-world data collection, (2) provide patients with a coaching mobile app interface, and (3) equip healthcare professionals with an interactive, patient-monitoring dashboard. The qualitative component will determine end-user usability and acceptability via end-of-study surveys and interviews. CONCLUSION: The first patient was enrolled in the study in January 2023. Recruitment will be ongoing until the project finishes before the end of 2023. IMPLICATIONS FOR NURSING PRACTICE: LifeChamps provides a comprehensive digital health platform to enable continuous monitoring of frailty indicators and health-related quality of life determinants in geriatric cancer care. Real-world data collection will generate "big data" sets to enable development of predictive algorithms to enable patient risk classification, identification of patients in need for a comprehensive geriatric assessment, and subsequently personalized care.

Cardio-ankle vascular index (CAVI) measured by a new device: protocol for a validation study.

INTRODUCTION: Cardio-ankle vascular index (CAVI) is a new marker of arterial stiffness (AS) that can assess vascular wall stiffness in the aorta, femoral artery and tibial artery. CAVI is less affected by blood pressure at the time of measurement than the gold standard method (carotid-femoral pulse wave velocity (PWV)). Our group has developed a device called VOPITB (Velocidad Onda de Pulso Índice Tobillo Brazo) that uses the oscillometric method and easily and accurately measures the PWV in the arms and legs separately, allowing new AS indices to be studied. This article describes the research protocol to determine CAVI using VOPITB and to validate the device against a reference device (VaSera VS-1500) and assess its clinical utility. METHODS AND ANALYSES: A cross-sectional, descriptive and observational study will be conducted. In all, 120 subjects (a minimum of 40% of subjects from any one gender) will be evaluated. CAVI will be determined from the measurement by VOPITB and VaSera VS-1500. For each subject, the average of the three readings taken with each device will be calculated. The Bland-Altman plot will be used to determine whether any bias exists in the data-that is, a tendency of the size of the difference to vary with the mean. The participants will be divided roughly equally between the following age bands: <30, 30-60 and >60 years. ETHICS AND DISSEMINATION: The study has been approved by the ethics committee of the Hospital San Pedro de Alcántara, Cáceres, Spain. The participants will be required to sign an informed consent form before inclusion in the study, in accordance with the Declaration of Helsinki and WHO standards for observational studies. The dissemination plan of the research study results will be through presentations in relevant national and international conferences and scientific publications in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04303546.