Towards Telemonitoring in Immune-Mediated Inflammatory Diseases: Implementation of a Mixed Attention Model (IMIDOC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IMIDOC.
- Who it may be relevant to
- Registry conditions: Telemedicine, Telehealth, eHealth, Rheumatic Diseases. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Towards Telemonitoring in Immune-Mediated Inflammatory Diseases: Implementation of a Mixed Attention Model
Overview
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.
Interventions
- Device IMIDOC
Patient´s Mobile App for recording clinical data
Primary outcome measures
- To assess the primary objective, composite endpoints that consider the viability, adherence and degree of satisfaction of the MAM are included [Time frame: 24 months]
Secondary outcome measures (1)
- To identify features associated with adherence to follow-up through the MAM. [Time frame: 24 months]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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
Identifiers
NCT: NCT06273306 · HULP.PI-4519 · PI22/00777