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Clinical Trials/NCT06273306
NCT06273306Not yet recruitingNot Applicable

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

Instituto de Investigación Hospital Universitario La Paz0 sites360 target enrollmentStarted: March 15, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
360
Primary Endpoint
To assess the primary objective, composite endpoints that consider the viability, adherence and degree of satisfaction of the MAM are included

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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).

Arms & Interventions

Digital care

Experimental

User of mobile APP for telemonitoring

Intervention: IMIDOC (Device)

Traditional care

No Intervention

Monitoring in face-to-face visits

Outcomes

Primary Outcomes

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

* 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.

Secondary Outcomes

  • To identify features associated with adherence to follow-up through the MAM.(24 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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