Improvement in Quality of Life With the Use of a Technological System Among Patients With Chronic Disease Followed Up in Primary Care (TeNDER Project): Protocol for a Randomized Controlled Trial (Preprint)

Abstract

BACKGROUND Within chronic diseases, cognitive, neurological, and cardiovascular impairments are becoming increasingly prevalent, generating a shift in health and social needs. Technology can create an ecosystem of care integrated with microtools based on biosensors for motion, location, voice, and expression detection that can help people with chronic diseases. A technological system capable of identifying symptoms, signs or behavioral patterns could alert patients with chronic diseases to the development of complications, aid them in self-care and save healthcare costs. As a result, the autonomy and empowerment of patients and their caregivers would be promoted, improving their quality of life, and health professionals would be provided with monitoring tools. OBJECTIVE The main objective of this study is to evaluate the effectiveness of a technological system (the TeNDER System) to improve quality of life in patients with chronic diseases: Alzheimer’s, Parkinson’s and cardiovascular disease. METHODS A multicenter, randomized, parallel-group, clinical trial will be conducted with a follow-up of 2 months. The scope of the study will be the primary care health centers in Madrid belonging to Spain’s Public Health System. The study population will be patients diagnosed with Parkinson’s, Alzheimer’s and cardiovascular disease, their caregivers and health professionals. The total sample size will be 534 patients (380 in the intervention group). The intervention will consist of the use of the TeNDER System. The system will monitor patients by means of biosensors, and their data will be integrated into the TeNDER application. With the information provided, the TeNDER system will generate health reports that can be viewed by patients, caregivers and health professionals. The primary outcome will be the difference in quality of life (measured with the SF36 questionnaire) between T0 and T1 and the corresponding 95% confidence interval (CI). Adjustment for confounding factors will be performed by multilevel analysis. RESULTS Recruitment of participants started in April 2021 and is ongoing. It is expected to end in April 2023. By 2023, the results will be disseminated in the form of scientific articles for publication. CONCLUSIONS This clinical trial of patients with highly prevalent chronic illnesses and the people most involved in their care will provide a more realistic view of the situation experienced by the long-term sick and their support networks. The TeNDER System is in continuous development based on results from the study of the target population and feedback from patients, caregivers and primary care health professionals. CLINICALTRIAL ClinicalTrials.gov NCT05681065. Registered on 11 January 2023.