背景:在慢性病中,认知,神经学,心血管损伤变得越来越普遍,产生健康和社会需求的转变。技术可以创建一个与基于生物传感器的微型工具集成的护理生态系统,location,声音,和表达检测可以帮助患有慢性病的人。能够识别症状的技术系统,标志,或行为模式可以提供疾病并发症发展的通知。这样有利于慢性病患者的自我保健,节省医疗费用,促进患者及其护理人员的自主性和赋权,提高他们的生活质量(QoL),并为卫生专业人员提供监测工具。
目的:本研究的主要目的是评估技术系统(TeNDER系统)改善慢性病患者生活质量的有效性:阿尔茨海默病,帕金森病,和心血管疾病。
方法:多中心,随机化,平行组临床试验将进行2个月的随访.研究范围将是马德里社区的初级保健保健中心,属于西班牙公共卫生系统。研究人群将是被诊断患有帕金森病的患者,阿尔茨海默病,和心血管疾病;他们的护理人员;和卫生专业人员。样本量为534名患者(干预组380名)。干预将包括使用TeNDER系统。该系统将通过生物传感器监测患者,他们的数据将集成到TeNDER应用程序中。根据所提供的信息,TeNDER系统将生成可供患者查阅的健康报告,看护者,和卫生专业人员。将测量社会人口统计学变量和技术亲和力,以及对TeNDER系统的可用性和满意度的看法。因变量将是干预组和对照组在2个月时QoL评分的平均差异。为了研究TeNDER系统在改善患者生活质量方面的有效性,将构建一个解释性线性回归模型。所有分析将使用95%CI和稳健估计器进行。
结果:该项目的道德批准已于2019年9月11日收到。该审判于2020年8月14日注册。招聘于2021年4月开始,预计结果将在2023年或2024年公布。
结论:这项针对慢性疾病高度流行患者和最多参与其护理的人群的临床试验将为长期疾病患者及其支持网络所经历的情况提供更现实的观点。TeNDER系统基于对目标人群需求的研究以及用户在使用过程中的反馈:患者,看护者,和初级保健保健专业人员。
背景:ClinicalTrials.govNCT05681065;https://clinicaltrials.gov/ct2/show/NCT05681065。
■DERR1-10.2196/47331。
Among 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 provide notification of the development of complications of disease. This would help the self-care of patients with chronic disease and save health care costs, promoting the autonomy and empowerment of patients and their caregivers, improving their quality of life (QoL), and providing health professionals with monitoring tools.
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 disease, Parkinson disease, and cardiovascular disease.
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 of the Community of Madrid belonging to the Spanish public health system. The study population will be patients diagnosed with Parkinson disease, Alzheimer disease, and cardiovascular disease; their caregivers; and health professionals. The 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 the patients by means of biosensors, and their data will be integrated into the TeNDER app. With the information provided, the TeNDER system will generate health reports that can be consulted by patients, caregivers, and health professionals. Sociodemographic variables and technological affinity will be measured, as will views on the usability of and satisfaction with the TeNDER system. The dependent variable will be the mean difference in QoL score between the intervention and control groups at 2 months. To study the effectiveness of the TeNDER system in improving QoL in patients, an explanatory linear regression model will be constructed. All analyses will be performed with the 95% CI and robust estimators.
Ethics approval for this project was received on September 11, 2019. The trial was registered on August 14, 2020. Recruitment commenced in April 2021, and the expected results will be available during 2023 or 2024.
This clinical trial among 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 people with long-term illness and their support networks. The TeNDER system is in continuous development based on a study of the needs of the target population and on feedback during its use from the users: patients, caregivers, and primary care health professionals.
ClinicalTrials.gov NCT05681065; https://clinicaltrials.gov/ct2/show/NCT05681065.
DERR1-10.2196/47331.