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

NCT06273306 | Not Yet Recruiting

• 2 other identifiers: HULP.PI-4519PI22/00777
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• To assess the primary objective, composite endpoints that consider the viability, adherence and degree of satisfaction of the MAM are included

  * Number of interactions in activity and electronic patient reported outcomes (ePRO) questionnaires per month. * Number of reported incidences per month. * Average time to contact the patient after reporting an incident. * Average number of interactions in educational material and other content per month. * Adherence to follow-up through the mixed atenttion model (MAM) will be evaluated through the number of visits and time per visit to the digital platform. * Percentage of incidents resolved telematically. * Average weekly hours that the digital clinician takes to review the professional's website and resolve incidents * Professionals and patients´ satisfaction will be assessed through the Net-Promoter-Score (NPS). Values from 0 to 6 ( detractors), 6-8 ( passives) and 9-10 promoters.

  24 months

Secondary Outcomes (1)

• To identify features associated with adherence to follow-up through the MAM.

  24 months

Study Arms (2)

Digital care

EXPERIMENTAL

User of mobile APP for telemonitoring

Device: IMIDOC

Traditional care

NO INTERVENTION

Monitoring in face-to-face visits

Interventions

IMIDOC DEVICE

Patient´s Mobile App for recording clinical data

Digital care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

Related Publications (1)

• 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.

  PMID: 38501508 DERIVED

MeSH Terms

Conditions

Rheumatic Diseases; Arthritis, Rheumatoid; Spondylarthritis

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Arthritis; Joint Diseases; Autoimmune Diseases; Immune System Diseases; Spondylitis; Spinal Diseases; Bone Diseases

Study Officials

• Chamaida Plasencia-Rodríguez, PhD

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chamaida Plasencia-Rodríguez, PhD

CONTACT

917277108; chamiplaro@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: February 22, 2024
• Study Start: March 15, 2024
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 22, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share