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

Instituto de Investigación Hospital Universitario La Paz

Status: Not yet enrolling

Conditions: eHealth; Spondylarthritis; Telemedicine; Rheumatic Diseases; Arthritis, Rheumatoid; Telehealth

Treatments: Device: IMIDOC

Study type: Interventional

Funder types: Other

Identifiers

NCT06273306

HULP.PI-4519

PI22/00777 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 2 patient groups

Digital care

Experimental group

Description:

User of mobile APP for telemonitoring

Treatment:

Device: IMIDOC

Traditional care

No Intervention group

Description:

Monitoring in face-to-face visits