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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Arthritis, Rheumatoid; Rheumatic Diseases; Spondylarthritis; Telemedicine; eHealth; Telehealth
• Intervention / Treatment: Device: IMIDOC

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chamaida Plasencia-Rodríguez, PhD; Phone Number: 917277108; Email: chamiplaro@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital care; User of mobile APP for telemonitoring	Device: IMIDOC; Patient´s Mobile App for recording clinical data
No Intervention: Traditional care; Monitoring in face-to-face visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Investigators: Principal Investigator: Chamaida Plasencia-Rodríguez, PhD, Hospital Universitario La Paz

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Estimated): February 22, 2024

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Arthritis; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Arthritis, Rheumatoid; Rheumatic Diseases; Collagen Diseases; Spondylitis; Spondylarthritis
• Other Study ID Numbers: HULP.PI-4519; PI22/00777 (Other Grant/Funding Number: Fondo de investigaciones sanitarias.Instituto de Salud Carlos III)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No