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

Arthritis, Rheumatoid Clinical Trial

— IMIDOC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06273306
• Other study ID #: HULP.PI-4519
• Secondary ID: PI22/00777
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2023
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: Chamaida Plasencia-Rodríguez, PhD
• Phone: 917277108
• Email: chamiplaro[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Collagen Diseases
• eHealth
• Rheumatic Diseases
• Spondylarthritis
• Spondylitis
• Telehealth
• Telemedicine

Intervention

Device:
• IMIDOC
Patient´s Mobile App for recording clinical data

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To identify features associated with adherence to follow-up through the MAM.	A 22-item self-administered survey adapted from the Unified Theory of Acceptance and Use of Technology (UTAUT) model will be used to measure app acceptance and intention to use: the variables will measured with 7-point scales for all model components as in the original UTAUT, where 1 equalled the negative end (fully disagree) and 7 the positive end of the scale (fully agree).; Agreement between patients' self-assessment and clinician assessment will be assessed comparing face-to-face visits at 6-months intervals with the closest assessment in the digital solution.; Number of face-to-face visits are avoided with the mixed atenttion model (MAM) in patients with stable disease activity.; Patients' eHealth literacy will be measured using the validated Spanish version of the eHealth Literacy Scale (eHEALS), measured on a 5-point scale in the range from 1 (strongly disagree) to 5 (strongly agree)	24 months