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

Official title

A Randomized Controlled Clinical Trial Investigating the Effects of the Digital App Rheumabuddy4.1 in Patients With Rheumatoid Arthritis

Overview

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

Detailed description

Rheumatoid arthritis (RA) incurs a substantial socioeconomic burden which has been supported by the Global Burden of Disease studies. 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.

Many RA patients experience a gap between the health care professionals (HCPs) and the patients regarding the understanding of living a life with a chronic disease - it is more than just blodsamples and swollen/tender joints.This trial addresses a critical, previously not well addressed, question of patient- and clinical importance about the support of using electronically patient reported outcomes (ePROs) ensuring high-quality life living with a chronic disease in patients with RA.

Digital health technology, as adjunct to standard routine care, provides a big opportunity to deliver continuous relevant, timely and cost-effective support to patients including support behavioural changes, improve quality of life and optimize treatment. Many (86%) of patients with RA agree that RA self-management apps can be very helpful, but the lack of high-quality and scientifically validated apps are needed.

The trial will create an evidence base covering the implications of disease- and treatment related concerns as well as non-adherence on quality of life (QoL), patient empowerment, clinical symptoms, and use of medication. Decision and policy makers need a transparent evidence base to substantiate the judgment behind any rational clinical rheumatology practice. The methodology is based on a 'bottom up' approach that hopefully will provide a state-of-the-art model for ensuring patient value in health care settings.

Altogether it is very likely that the use of data collected in RB4.1 will be of significant benefit to both patients with RA and HCPs.

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

Interventions

• Device Digital app RB4.1
  Standard care and the digital app RB4.1
• Other Control arm
  Standard care alone

Primary outcome measures

• Patient Global Assessment [Time frame: Week 12, Week 24, change from baseline]

Secondary outcome measures (9)

• Disease-activity Score28 using C-reactive protein (DAS28-CRP) [Time frame: Week 12, Week 24, change from baseline]
• Self-Efficacy (ASES-8) [Time frame: Week 12, Week 24, change from baseline]
• Pain (VAS) [Time frame: Week 12, Week 24, change from baseline]
• Fatigue (VAS) [Time frame: Week 12, Week 24, change from baseline]
• Health related quality of life (EQ-5D) [Time frame: Week 12, Week 24, change from baseline]
• Physical function (MD-HAQ) [Time frame: Week 12, Week 24, change from baseline]
• Well-Being (WHO-5) [Time frame: Week 12, Week 24, change from baseline]
• Medication Adherence (MMAS-8) [Time frame: Week 12, Week 24, change from baseline]
• Perceived Efficacy in Patient-Physician Interactions (PEPPI-5) [Time frame: Week 12, Week 24, change from baseline]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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.
• Other autoimmune diseases based on patient anamnesis/medical journal.
• Mental diseases based on patient anamnesis/medical record.
• All other non-pharmacological therapies that may impact the course of RA judged by the treating physician.
• Any comorbid condition, that in the opinion of the investigator would interfere with the conduction of the trial or the interpretation of the study outcome.
• Previous use of health apps related to the RA disease.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

Denmark · 1 center

• The Parker Institute, Bispebjerg and Frederiksberg Hospital — Frederiksberg

Identifiers

NCT: NCT06337786 · MSK-2023-TSJ1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗