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

NCT ID: NCT06273306

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-15
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Digital care

User of mobile APP for telemonitoring

Group Type: EXPERIMENTAL

IMIDOC

Intervention Type: DEVICE

Patient´s Mobile App for recording clinical data

Traditional care

Monitoring in face-to-face visits

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

IMIDOC

Patient´s Mobile App for recording clinical data

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigación Hospital Universitario La Paz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chamaida Plasencia-Rodríguez, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Paz

Central Contacts

Chamaida Plasencia-Rodríguez, PhD

Role: CONTACT

chamiplaro@gmail.com

917277108

References

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. JMIR Res Protoc. 2024 Apr 22;13:e55829. doi: 10.2196/55829.

Reference Type: DERIVED

PMID: 38501508 (View on PubMed)

Other Identifiers

PI22/00777

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HULP.PI-4519

Identifier Type: -

Identifier Source: org_study_id