NCT05496855

Remote Care in People With Rheumatoid Arthritis

Can Machine Learning and Patient-reported Outcomes be Used in Remote Care in People With Rheumatic Diseases

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 228 (estimated)
• Sponsor: Diakonhjemmet Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a 24-months, non-inferiority randomized, controlled trial with two parallel arms to determine if a new follow-up strategy for patients with RA is non-inferior in maintaining comprehensive disease control measured as simultaneous maintenance of structural, functional and clinical treatment target at 2-year follow-up compared to the conventional follow-up regimen with regular hospital visits.

Detailed description

The study will include Norwegian adult males and females with rheumatoid arthritis. Eligible patients that consent to participation will be randomized to two groups: * Control group: conventional follow-up strategy with blood tests, patient-reported outcomes (PROs), and pre-scheduled visits at the hospital every 6th month. * Remote monitoring: monthly remote monitoring of PROs and triage of patients using an algorithm will guide healthcare providers in scheduling patients for a video consultation or face-to-face hospital visits. Participants will be followed for 24 months. Primary outcome is proportionn maintaining comprehensive disease control measured as simultaneous maintenance of structural, functional and clinical treatment target at 2-year follow-up1. * Structural: Assessed with radiographs of hands and feet according to the van der Heijde modified Sharpe score (subscores for erosions (0-280) and joint space narrowing (0-168)), with a total range of 0-448. Maintenance of structural treatment target is defined as change in total score \<1 unit/year (\<2 units from inclusion to 2-year follow-up). * Functional: Measured by Modified Health Assessment Questionnaire (MHAQ) measured on a scale from 0.00 to 3.00, where a change of 0.25 is considered clinical important3. Maintenance of functional treatment target is defined as a worsening \<0.25 from inclusion to 2-year follow-up. * Clinical: Measured by DAS28, categorized into remission (\<2.6), low disease activity (2.6 to ≤3.2), moderate disease activity (3.2 to ≤5.1) and high disease activity (\>5.1). Maintenance of clinical treatment target is defined disease activity category at 2-year follow-up ≤ baseline category. We will use a 15% non-inferiority margin. The study will comprise an internal pilot study the first 6 months for all participants in the intervention group. The study will also include qualitative research including semi-structured interviews and observations of patients in the intervention group and health professionals involved in the study. The interviews will explore experiences with remote monitoring and video consultations.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
OTHER	Conventional follow-up	Patients in the conventional/usual care arm will be treated according to current conventional follow-up regimen with PROs, blood tests, and face-to-face visits with an experienced nurse or a rheumatologist every 6 months. They can contact the hospital if they are experience worsening of their disease.
OTHER	Remote monitoring	The patients in the remote monitoring arm will use a web-app (Youwell) for self-reporting patient reported outcomes (PROs) and CRP/ESR, displaying results for PROs over time, and for synchronous (video) or asynchronous (chat) communication with healthcare providers. The patients will receive a SMS reminder for "tasks" (e.g., self-reporting PROs or registering results from blood tests) every month. A study coordinator/nurse will monitor the PROs and blood test (CRP/ESR) results, and respond to chat messages. Based on the algorithm, a triaging functionality in the Youwell platform will aid healthcare providers in highlighting which patients needs attention.

Timeline

• Start date: 2022-09-29
• Primary completion: 2026-06-30
• Completion: 2028-10-14
• First posted: 2022-08-11
• Last updated: 2025-04-20

Locations

1 site across 1 country: Norway