NCT06273306: IMIDOC

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

Not yet recruiting NA Last updated 22 February 2024

What this trial tests

NA trial testing IMIDOC in Telemedicine in 360 participants. Not yet recruiting.

Timeline

15 March 2024

Primary endpoint
31 December 2024

31 December 2026

Quick facts

Lead sponsor	Instituto de Investigación Hospital Universitario La Paz
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	360
Start date	15 March 2024
Primary completion	31 December 2024
Estimated completion	31 December 2026

Drugs / interventions tested

• IMIDOC

Conditions studied

• Telemedicine — all drugs for Telemedicine →
• Telehealth — all drugs for Telehealth →
• eHealth — all drugs for eHealth →
• Rheumatic Diseases — all drugs for Rheumatic Diseases →

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Who can join

Adults 18 to 80, any sex, with Telemedicine or Telehealth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Digital Health Intervention for Patient Monitoring in Immune-Mediated Inflammatory Diseases: Cocreation and Feasibility Study of the IMIDoc Platform.
   Benavent D, Iniesta-Chamorro JM, Novella-Navarro M, Pérez-Martínez M, et al · · 2025 · cited 2× · PMID 40267421 · DOI 10.2196/58095
2. Toward Telemonitoring in Immune-Mediated Inflammatory Diseases: Protocol for a Mixed Attention Model Study.
   Novella-Navarro M, Iniesta-Chamorro JM, Benavent D, Bachiller-Corral J, et al · · 2024 · PMID 38501508 · DOI 10.2196/55829