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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство IMIDOC
  Patient´s Mobile App for recording clinical data

Первичные конечные точки

• To assess the primary objective, composite endpoints that consider the viability, adherence and degree of satisfaction of the MAM are included [Срок оценки: 24 months]

Вторичные конечные точки (1)

• To identify features associated with adherence to follow-up through the MAM. [Срок оценки: 24 months]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Novella-Navarro M, Iniesta-Chamorro JM, Benavent D, Bachiller-Corral J, Calvo-Aranda E, Borrell H, Berbel-Arcobe L, Navarro-Compan V, Michelena X, Lojo-Oliveira L, Arroyo-Palomo J, Diaz-Almiron M, Garcia Garcia V, Monjo-Henry I, Gomez Gonzalez CM, Gomez EJ, Balsa A, Plasencia-Rodriguez C. Toward Telemonitoring in Immune-Mediated Inflammatory Diseases: Protocol for a Mixed Attention Model Study. JM PMID 38501508

Идентификаторы

NCT: NCT06273306 · HULP.PI-4519 · PI22/00777

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗