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Multicenter Study
. 2024 Apr 22:13:e55829.
doi: 10.2196/55829.

Toward Telemonitoring in Immune-Mediated Inflammatory Diseases: Protocol for a Mixed Attention Model Study

Marta Novella-Navarro #  1 , Jose M Iniesta-Chamorro #  2 , Diego Benavent  3 , Javier Bachiller-Corral  4 , Enrique Calvo-Aranda  5 , Helena Borrell  6 , Laura Berbel-Arcobé  3 , Victoria Navarro-Compan  1 , Xabier Michelena  6 , Leticia Lojo-Oliveira  5 , Jaime Arroyo-Palomo  4 , Mariana Diaz-Almiron  7 , Verónica García García  4 , Irene Monjo-Henry  1 , Claudia María Gómez González  5 , Enrique J Gomez  2   8 , Alejandro Balsa  1 , Chamaida Plasencia-Rodríguez  1
Affiliations
Multicenter Study

Toward Telemonitoring in Immune-Mediated Inflammatory Diseases: Protocol for a Mixed Attention Model Study

Marta Novella-Navarro et al. JMIR Res Protoc. .

Abstract

Background: 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.

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Trial registration: ClinicalTrials.gov NCT06273306; https://clinicaltrials.gov/ct2/show/NCT06273306.

International registered report identifier (irrid): PRR1-10.2196/55829.

Keywords: MAM; antirheumatic drugs; care model; chronic diseases; clinical outcome; digital health; digital resources, mixed attention model; hybrid care model; implementation; inflammation; mHealth, telemonitoring, rheumatic musculoskeletal diseases; musculoskeletal diseases; pain; rheumatic disease; rheumatology; telemonitoring.

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Conflict of interest statement

Conflicts of Interest: MNN reports grants from UCB Pharma, Lilly, Galapagos, and Janssen outside the submitted work. DBN reports grants from Lilly, Janssen, UCB Pharma, MSD, Galapagos, and Novartis. ECA reports grants from Menarini, Grünenthal, Asac Pharma, MSD, Lilly, Pfizer, Roche, Astra-Zeneca, and Galapagos. HB reports grants from Lilly, Abbvie, Galapagos, Bristol Myers Squibb (BMS), Nordic Pharma, and UCB Pharma. LBA reports grants from Novartis, Lilly, Janssen, MSD, Theramex, and Abbvie. VNC reports grants from Abbvie, Lilly, Fresenius Kabi, Janssen, MSD, Novartis, Pfizer, and UCB Pharma. IMH reports grants from Roche, Novartis, UCB, and Gedeon Richter outside the submitted work. CP-R reports grants from AbbVie, Pfizer, Novartis, Lilly, and Roche outside the submitted work. AB reports grants from AbbVie, Amgen, Pfizer, Galapagos, Novartis, Gilead, BMS, Nordic, Sanofi, Sandoz, Lilly, UCB, and Roche outside the submitted work. The rest of the authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1
Flowchart describing the inclusion in the study and the different steps according to the timetable established for the face-to-face and digital visits. ePRO: electronic patient-reported outcome; IC: informed consent; RA: rheumatoid arthritis; SpA: spondyloarthritis.
Figure 2
Figure 2
Digital health solution outline. ePRO: electronic patient-reported outcome; RMD: rheumatic and musculoskeletal disease.
See this image and copyright information in PMC

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