Remote Care in People With Rheumatoid Arthritis

NCT05496855 | Active Not Recruiting

• 1 other identifier: REK 457358
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

remote care

Outcome Measures

Primary Outcomes (1)

• Proportion maintaining comprehensive disease control

  Comprehensive disease control measured as simultaneous maintenance of structural, functional and clinical treatment target at 2-year follow-up. * Structural: Radiographs of hands and feet according to the van der Heijde modified Sharpe score, 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: Modified Health Assessment Questionnaire (MHAQ) measured on a scale from 0.00 to 3.00, where a change of 0.25 is considered clinical important. Maintenance of functional treatment target is defined as a worsening \<0.25 from inclusion to 2-year follow-up. * Clinical: 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.

  Baseline and 2 years

Secondary Outcomes (39)

• Change in joint damage progression

  Baseline and 2 years

• Self-reported disease activity (intervention group)

  Monthly until 2 years

• Self-reported disease activity (control group)

  Baseline, 6 months, 12 months, 18 months and 2 years

• Health-related quality of life

  Baseline, 6 months, 12 months, 18 months and 2 years

• Proportion in remission/low disease activity (CDAI)

  Baseline and 2 years

Study Arms (2)

Conventional follow-up

ACTIVE COMPARATOR

Conventional follow-up strategy with blood tests and face-to-face visits at the hospital every 6 months

Other: Conventional follow-up

Remote monitoring

EXPERIMENTAL

Monthly remote monitoring of patient-reported outcomes and triage of patients using an algorithm will guide healthcare providers in scheduling patients for a video consultation or face-to-face hospital visits.

Other: Remote monitoring

Interventions

Conventional follow-up OTHER

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.

Also known as: Control group

Conventional follow-up

Remote monitoring OTHER

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.

Also known as: Intervention group

Remote monitoring

Eligibility Criteria

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

You may qualify if:

• Male or non-pregnant, non-nursing female ≥18 years of age at screening
• Patients with a diagnosis of RA who fulfil the 2010 ACR/EULAR diagnostic criteria24 (see Appendix 5, 10.4)
• Medical treatment with cs/ts/bDMARDs (incl. prednisolone) considered stable by the healthcare provider the last 6 months
• \<2 swollen joints
• Not deemed inappropriate for remote monitoring by the healthcare provider
• Capable of understanding and signing an informed consent form
• Access to a smartphone or tablet
• Able to speak and understand Norwegian language

You may not qualify if:

• Medical conditions:
• Major co-morbidities, such as severe malignancies, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease (NYHA class III or IV), severe respiratory diseases, and/or cirrhosis.
• Indications of active tuberculosis (TB)
• Treated with intravenous DMARD (e.g., rituximab and infliximab)
• Diagnostic assessments:
• Abnormal renal function, defined as serum creatinine \>142 µmol/L in female and \>168 µmol/L in male, or glomerular filtration rate (GFR) \<40 mL/min/1.73 m2
• Abnormal liver function (defined as Aspartate Transaminate (AST)/Alanine Transaminase (ALT) \>3 x upper normal limit), active or recent hepatitis
• Leukopenia and/or thrombocytopenia
• Other:
• Pregnancy and/or breastfeeding (current at screening or planned within the duration of the study)
• Severe psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible.
• Deemed unsuitable for remote monitoring by medical doctor

Sponsors & Collaborators

• Diakonhjemmet Hospital: lead

Study Sites (1)

Diakonhjemmet Hospital

Oslo, 0319, Norway

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Control Groups; Remote Patient Monitoring

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Anne Therese Tveter, PhD

  Diakonhjemmet Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Senior researcher/Assosiate Professor

Model Details: Randomized controlled non-inferiority trial

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 11, 2022
• Study Start: September 29, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 14, 2028
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)