Novella-Navarro Marta, Iniesta-Chamorro Jose M, Benavent Diego, Bachiller-Corral Javier, Calvo-Aranda Enrique, Borrell Helena, Berbel-Arcobé Laura, Navarro-Compan Victoria, Michelena Xabier, Lojo-Oliveira Leticia, Arroyo-Palomo Jaime, Diaz-Almiron Mariana, García García Verónica, Monjo-Henry Irene, Gómez González Claudia María, Gomez Enrique J, Balsa Alejandro, Plasencia-Rodríguez Chamaida
Rheumatology Department, Hospital Universitario La Paz, Madrid, Spain.
Biomedical Engineering and Telemedicine Centre, Center for Biomedical Technology, Escuela Tecnica Superior de Ingenieros de Telecomunicacion, Universidad Politecnica de Madrid, Madrid, Spain.
JMIR Res Protoc. 2024 Apr 22;13:e55829. doi: 10.2196/55829.
Rheumatic and musculoskeletal diseases (RMDs) are chronic diseases that may alternate between asymptomatic periods and flares. These conditions require complex treatments and close monitoring by rheumatologists to mitigate their effects and improve the patient's quality of life. Often, delays in outpatient consultations or the patient's difficulties in keeping appointments make such close follow-up challenging. For this reason, it is very important to have open communication between patients and health professionals. In this context, implementing telemonitoring in the field of rheumatology has great potential, as it can facilitate the close monitoring of patients with RMDs. The use of these tools helps patients self-manage certain aspects of their disease. This could result in fewer visits to emergency departments and consultations, as well as enable better therapeutic compliance and identification of issues that would otherwise go unnoticed.
The main objective of this study is to evaluate the implementation of a hybrid care model called the mixed attention model (MAM) in clinical practice and determine whether its implementation improves clinical outcomes compared to conventional follow-up.
This is a multicenter prospective observational study involving 360 patients with rheumatoid arthritis (RA) and spondylarthritis (SpA) from 5 Spanish hospitals. The patients will be followed up by the MAM protocol, which is a care model that incorporates a digital tool consisting of a mobile app that patients can use at home and professionals can review asynchronously to detect incidents and follow patients' clinical evolution between face-to-face visits. Another group of patients, whose follow-up will be conducted in accordance with a traditional face-to-face care model, will be assessed as the control group. Sociodemographic characteristics, treatments, laboratory parameters, assessment of tender and swollen joints, visual analog scale for pain, and electronic patient-reported outcome (ePRO) reports will be collected for all participants. In the MAM group, these items will be self-assessed via both the mobile app and during face-to-face visits with the rheumatologist, who will do the same for patients included in the traditional care model. The patients will be able to report any incidence related to their disease or treatment through the mobile app.
Participant recruitment began in March 2024 and will continue until December 2024. The follow-up period will be extended by 12 months for all patients. Data collection and analysis are scheduled for completion in December 2025.
This paper aims to provide a detailed description of the development and implementation of a digital solution, specifically an MAM. The goal is to achieve significant economic and psychosocial impact within our health care system by enhancing control over RMDs.
ClinicalTrials.gov NCT06273306; https://clinicaltrials.gov/ct2/show/NCT06273306.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/55829.
风湿性和肌肉骨骼疾病(RMDs)是慢性疾病,可能在无症状期和发作期之间交替。这些病症需要复杂的治疗,并由风湿病专家密切监测,以减轻其影响并提高患者的生活质量。通常,门诊咨询的延迟或患者在预约方面的困难使得这种密切随访具有挑战性。因此,患者与医疗专业人员之间保持开放的沟通非常重要。在这种情况下,在风湿病领域实施远程监测具有很大潜力,因为它可以促进对RMD患者的密切监测。使用这些工具有助于患者自我管理其疾病的某些方面。这可能会减少急诊就诊和咨询次数,并实现更好的治疗依从性,以及发现那些否则会被忽视的问题。
本研究的主要目的是评估一种名为混合关注模型(MAM)的混合护理模式在临床实践中的实施情况,并确定与传统随访相比,其实施是否能改善临床结果。
这是一项多中心前瞻性观察性研究,涉及来自5家西班牙医院的360名类风湿性关节炎(RA)和脊柱关节炎(SpA)患者。患者将按照MAM方案进行随访,该方案是一种护理模式,包含一个数字工具,即一款患者可在家中使用且专业人员可异步查看的移动应用程序,以检测事件并跟踪患者在面对面就诊之间的临床进展。另一组患者将按照传统的面对面护理模式进行随访,并作为对照组进行评估。将收集所有参与者的社会人口统计学特征、治疗方法、实验室参数、压痛和肿胀关节评估、疼痛视觉模拟量表以及电子患者报告结局(ePRO)报告。在MAM组中,这些项目将通过移动应用程序以及与风湿病专家面对面就诊时进行自我评估,风湿病专家对传统护理模式中的患者也将进行同样的操作。患者能够通过移动应用程序报告任何与疾病或治疗相关的事件。
参与者招募于2024年3月开始,将持续到2024年1