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临床试验/NCT06273306
NCT06273306尚未招募不适用

Towards Telemonitoring in Immune-Mediated Inflammatory Diseases: Implementation of a Mixed Attention Model

Instituto de Investigación Hospital Universitario La Paz0 个研究点目标入组 360 人开始时间: 2024年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
360
主要终点
To assess the primary objective, composite endpoints that consider the viability, adherence and degree of satisfaction of the MAM are included

研究概览

简要总结

The main objective is to evaluate the implementation of a hybrid care model called the mixed attention model (MAM) in clinical practice and to evaluate 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 five Spanish Hospitals. Patients will be followed-up by the MAM protocol, which is a care model that incorporates the use of digital tool consisting of a mobile application (App) that patients can use at home and that professionals can review asynchronously to detect incidents and to follow their 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 analogue scale for pain and electronic patient reported outcome reports (ePROs) will be collected for all subjects. In the MAM group, these items will be self-assessed both by the mobile App and during face-to-face visits with rheumatologist, who will do the same for patients included in the traditional care model. Patients will be able to report any incidence related to their disease or treatment through the mobile App.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis with Rheumatoid Arthritis or Spondylarthritis
  • Treatment with biologic or targeted disease modifying antirheumatic drugs.
  • Ability to use smartphone.

排除标准

  • only patients with conditions that hinder or prevent the use of a mobile application (blindness, mental retardation, dementia, digitalfilliteracy).

结局指标

主要结局

To assess the primary objective, composite endpoints that consider the viability, adherence and degree of satisfaction of the MAM are included

时间窗: 24 months

* Number of interactions in activity and electronic patient reported outcomes (ePRO) questionnaires per month. * Number of reported incidences per month. * Average time to contact the patient after reporting an incident. * Average number of interactions in educational material and other content per month. * Adherence to follow-up through the mixed atenttion model (MAM) will be evaluated through the number of visits and time per visit to the digital platform. * Percentage of incidents resolved telematically. * Average weekly hours that the digital clinician takes to review the professional's website and resolve incidents * Professionals and patients´ satisfaction will be assessed through the Net-Promoter-Score (NPS). Values from 0 to 6 ( detractors), 6-8 ( passives) and 9-10 promoters.

次要结局

  • To identify features associated with adherence to follow-up through the MAM.(24 months)

研究者

申办方类型
Other
责任方
Sponsor

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