protocolSection identificationModule nctId: NCT06337786, orgStudyIdInfo id: MSK-2023-TSJ1, briefTitle: Investigating the Effects of the Digital App Rheumabuddy4.1 in a Clinical Set-up in Patients With Rheumatoid Arthritis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Henning Bliddal, class: OTHER, collaborators name: Eurostars, collaborators name: DAMAN, collaborators name: Medical University of Vienna, descriptionModule briefSummary: Rheumatoid arthritis (RA) is one of the most frequently occurring autoimmune rheumatic diseases, affecting an estimated 1% of the global population (1). RA is a chronic inflammatory disease that leads to the development of synovial inflammation and effusion, ultimately followed by joint destruction and permanent disability.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, conditionsModule conditions: Rheumatoid Arthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The trial is an open-label matched register controlled clinical trial with two parallel groups (intervention and matched controls from the DANBIO register).The number of study participants is 40 in the intervention arm and up to 120 in the matched control arm., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Digital app RB4.1, interventions name: Control arm, outcomesModule primaryOutcomes measure: Primary Outcome, secondaryOutcomes measure: Disease-activity Score28 using C-reactive protein (DAS28-CRP), secondaryOutcomes measure: Self-Efficacy, secondaryOutcomes measure: Pain and Fatigue, secondaryOutcomes measure: Health related quality of life, secondaryOutcomes measure: Physical function/activity, secondaryOutcomes measure: Well-Being, otherOutcomes measure: Medication Adherence, otherOutcomes measure: Better alignment between patient and health care professionals, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 74 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Parker Institute, Bispebjerg and Frederiksberg Hospital, city: Frederiksberg, state: Copenhagen F, zip: 2000, country: Denmark, contacts name: Tanja Schjødt Jørgensen, role: CONTACT, phone: +4538164173, email: tanja.schjoedt.joergensen@regionh.dk, contacts name: Lars Erik Kristensen, role: CONTACT, phone: +4538164157, email: lars.erik.kristensen@regionh.dk, geoPoint lat: 55.67938, lon: 12.53463, hasResults: False