Investigating the Effects of the Digital App Rheumabuddy4.1 in a Clinical RCT Set-up in Patients With Rheumatoid Arthritis

NCT06337786 | Recruiting

• 1 other identifier: MSK-2023-TSJ1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Rheumatoid arthritis (RA) is one of the most frequently occurring autoimmune rheumatic diseases, affecting an estimated 1% of the global population. RA is a chronic inflammatory disease that leads to the development of synovial inflammation and effusion, ultimately followed by joint destruction and permanent disability. The substantial socioeconomic burden and the challenge of RA patients adhering to treatment is an important factor of this disease and its impact on both patients and society. An innovative approach is needed in order to find new ways to assist and truly empower patients to understand their disease, increase compliance and thereby increase quality of life. There is a discrepancy in the understanding of what's of importance when living a life with a chronic disease. The importance of patients' perspectives concerning disease- and treatment related impacts, is of crucial importance when involving patients in decisions about treatment, and to support the patients in optimal medication-taking behaviour to ensure patient health and reduce health care costs. There are still unmet needs that have a huge impact on quality of life (QoL) such as fatigue, pain, sleep and psychological issues, etc, which need to be taken seriously as these can have severe and debilitating consequences for the individual. The aim of this study is to investigate and evaluate the effects of the digital app RheumaBuddy4.1 (RB4.1) and the ability to provide support and increase quality of life in patients with RA

Conditions

Rheumatoid Arthritis

Keywords

Patient Perspectives; Digital app; Quality of life; Empowerment; Socioeconomic burden

Outcome Measures

Primary Outcomes (1)

• Patient Global Assessment

  Patient Global Assessment (PGA) is scored using a visual analogue scale (VAS) range from 0-100 mm. Higher scores represent a higher level of disease activity or a worse global health. The PGA is one of the most widely reported PROs in RA. The considerable burden of RA on the individual is related to both inflammation and damage but also to broader aspects of disease, including psychological and societal impact. The way PGA is used in clinical practices covers, in fact, two very different concepts, one related to global health and the other to overall disease activity They are both usually used under the heading of PGA without further specification for which is being assessed.

  Week 12, Week 24, change from baseline

Secondary Outcomes (9)

• Disease-activity Score28 using C-reactive protein (DAS28-CRP)

  Week 12, Week 24, change from baseline

• Self-Efficacy (ASES-8)

  Week 12, Week 24, change from baseline

• Pain (VAS)

  Week 12, Week 24, change from baseline

• Fatigue (VAS)

  Week 12, Week 24, change from baseline

• Health related quality of life (EQ-5D)

  Week 12, Week 24, change from baseline

Study Arms (2)

Intervention arm

EXPERIMENTAL

Patients diagnosed with rheumatoid arthritis receiving standard care and the digital app RB4.1

Device: Digital app RB4.1

Control arm

ACTIVE COMPARATOR

Patients diagnosed with rheumatoid arthritis receiving standard care alone.

Other: Control arm

Interventions

Digital app RB4.1 DEVICE

Standard care and the digital app RB4.1

Intervention arm

Control arm OTHER

Standard care alone

Control arm

Eligibility Criteria

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

You may qualify if:

• An individual must meet all of the following criteria to be enrolled in the study:
• Diagnosed with RA according to the EULAR \& American College of Rheumatology
• PGA level \>= 40mm
• Age ≥ 18 years and \< 65 years
• Motivated for the intervention
• Willing and able to understand and participate in the study
• DAS28-CRP ≤ 3.2.
• Ability to use the RB4.1 app

You may not qualify if:

• An individual will be excluded from the study if she meets any of the following criteria:
• Dementia or other linguistic/cognitive/physical deficiency that prevents participation
• Vision impairment that prevents the use of the devices and computer
• Change in DMARD (within 8 weeks)
• Chronic widespread pain (fibromyalgia) based on patient anamnesis/medical record.
• Acute infections based on patient anamnesis/medical record.
• Severe asthma based on patient anamnesis/medical record.
• Severe COPD based on patient anamnesis/medical record.
• Instable heart disease based on patient anamnesis/medical record.
• Intensive physiotherapy outside standard care based on patient anamnesis/medical record.
• Electrostimulation based on patient anamnesis/medical record.
• Motivation training based on patient anamnesis/medical record.
• Smoking based on patient anamnesis/medical record.
• Fever based on patient anamnesis/medical record.
• If pain/fatigue are considered a side effect judged by the treating physician.

Sponsors & Collaborators

• Henning Bliddal: lead
• Eurostars: collaborator
• DAMAN: collaborator
• Medical University of Vienna: collaborator

Study Sites (1)

The Parker Institute, Bispebjerg and Frederiksberg Hospital

Frederiksberg, Copenhagen F, 2000, Denmark

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Empowerment

Condition Hierarchy (Ancestors)

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

Study Officials

• Henning Bliddal

  The Parker Institute, Bispebjerg and Frederiksberg Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tanja Schjødt Jørgensen

CONTACT

+4538164173; tanja.schjoedt.joergensen@regionh.dk

Line Rustad

CONTACT

+4538164158; line.rustad@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: The trial is an open-label randomized controlled clinical trial with two parallel groups . The participants will be randomly allocated in a 1:1 manner receiving either standard care and the digital app RB4.1 or standard care alone.

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 29, 2024
• Study Start: March 31, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-03

Locations

DK (1)