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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Other: Control arm; Device: Digital app RB4.1

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

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tanja Schjødt Jørgensen; Phone Number: +4538164173; Email: tanja.schjoedt.joergensen@regionh.dk
• Study Contact Backup: Name: Line Rustad; Phone Number: +4538164158; Email: line.rustad@regionh.dk

Study Locations

• Denmark
  • Copenhagen F
    • Frederiksberg, Copenhagen F, Denmark, 2000
      • The Parker Institute, Bispebjerg and Frederiksberg hospital
      • Contact: Tanja Schjødt Jørgensen; Phone Number: +4538164173; Email: tanja.schjoedt.joergensen@regionh.dk
      • Contact: Lars Erik Kristensen; Phone Number: +4538164157; Email: lars.erik.kristensen@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• An individual must meet all of the following criteria to be enrolled in the study:

  1. Diagnosed with RA according to the EULAR & American College of Rheumatology
  2. PGA level >= 40mm
  3. Age ≥ 18 years and < 75 years
  4. Motivated for the intervention
  5. Willing and able to understand and participate in the study
  6. 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:

  1. Dementia or other linguistic/cognitive/physical deficiency that prevents participation
  2. Vision impairment that prevents the use of the devices and computer
  3. Change in DMARD (within 8 weeks)
  4. > CDAI 15
  5. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control arm; Matched controls from the DANBIO register receiving standard routine care. Up to 3 patients will be matched based on sex, age (+/-5 years), time at enrolment (< 2 years prior to index date is allowed) and DAS28 scores (+/- 0.4).	Other: Control arm; Standard routine care
Experimental: Intervention arm; Patients diagnosed with rheumatoid arthritis receiving standard routine care and the digital app RB4.1.	Device: Digital app RB4.1; Standard routine care and the digital app RB4.1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome	Patient Global Assessment Score. 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-activity Score28 using C-reactive protein (DAS28-CRP)	Disease activity of rheumatoid arthritis (RA) is usually assessed by using Disease Activity Score 28-joint count (DAS28). DAS28 scores range from 0 to 9.4 and are calculated using tender joints, swollen joints, general health, and a laboratory measure of acute inflammation. DAS28 for RA with C-reactive protein (DAS28-CRP) describes the severity of RA using clinical and laboratory data, specifically CRP	Week 12, Week 24, change from baseline
Self-Efficacy	ASES-8 has been used in evaluations of self-management education programs, physical activity interventions, and associations of self-efficacy with various health outcomes. The ASES-8 includes 2 items from the ASES pain subscale, 4 items from the ASES other symptoms subscale, and 2 new items related to preventing pain and fatigue from interfering with things you want to do. The total scale includes 8 items with no subscales: 1 (very uncertain) to 10 (very certain). Item stem for each question begins "How certain that you can....". The score for the scale is the mean of the eight items.	Week 12, Week 24, change from baseline
Pain and Fatigue	Pain and Fatigue will be assessed using the 0-100 mm visual analogue scale (VAS) with anchors 0 = "no pain/fatigue" and 100 = "Worst imaginable pain/fatigue".	Week 12, Week 24, change from baseline
Health related quality of life	The EQ-5D questionnaire is developed by the EuroQoL (18). The EQ-5D is a five-dimensional health state classification. The five dimensions are mobility, self-care, usual activities, pain/discomfort and anxiety/depression. It is a preference-based measure that can be regarded as a continuous outcome scored on a -0.59 to 1.00 scale, with 1.00 indicating 'full health' and 0 representing dead. The negative EQ-5D scores represent certain health states valued as worse than dead. Each topic is rated on a 3-point Likert scale: 1) no problems, 2) some problems, and 3) extreme problems. Instructions on how to response is included in the questionnaire. In addition, a VAS scale functions as a 6-question to report on self-reported overall health on a 0-100 scale where 100= best imaginable health and 0=worst health you can imagine. The VAS can be used as a quantitative measure of the patient's own judgement of overall health.	Week 12, Week 24, change from baseline
Physical function/activity	The Multi-Dimensional Health Assessment Questionnaire (MD-HAQ) is derived from the HAQ Health Assessment Questionnaire, which includes an index of the three rheumatoid arthritis (RA) core data set measures (physical function, pain and global estimate). It consists of 10 questions addressing eight different areas of functional ability and yields a total score between 0 and 3, with a higher score representing increasing disability. The MD-HAQ is useful in all rheumatic diseases by saving time, documenting changes in status over long periods and by improving rheumatology care and outcomes.	Week 12, Week 24, change from baseline
Well-Being	Mental health is a state of mental well-being that enables people to cope with the stresses of life, realize their abilities, learn well and work well, and contribute to their community. Well-Being will be assessed using the 5-item Well-Being Index (WHO-5). The WHO-5 is a validated assessment tool used to measure mental well-being in a variety of patient populations. The raw score is calculated by totalling the figures of the five answers. The raw score ranges from 0 to 25; 0 representing worst possible quality of life and 25 representing best possible quality of life.	Week 12, Week 24, change from baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Adherence	Adherence to medication will be assessed using the 8-item Morisky Medication Adherence Scale (MMAS-8). The MMAS-8 is a validated assessment tool used to measure non-adherence in a variety of patient populations. The scale consists of eight questions, MMAS-8 scores can range from 0 to 8 points. According to the MMAS-8, adherence can be categorized as high adherence (score, 8), medium adherence (score, 6 to<8) and low adherence (score, <6).	Week 12, Week 24, change from baseline
Better alignment between patient and health care professionals	The Perceived Efficacy in Patient-Physician Interactions (PEPPI) scale was developed to measure older patients' self-efficacy in both obtaining medical information and attention to their chief health concern from a physician. The PEPPI 5-item short form will be used to assess adherence and was developed from the items demonstrating the most variability while maintaining adequate internal consistency and construct validity from the original PEPPI. The PEPPI-5 includes five items; each item starts with "how confident are you in your ability to..? " Items are rated by participants from one to five; 1 = "not at all confident",5= "very confident". The totalled results are in the range of 5 to 25; higher scores indicate that the participant has higher self-efficacy in patient-physician interactions .	Week 12, Week 24, change from baseline

Collaborators and Investigators

• Sponsor: Henning Bliddal
• Collaborators: Medical University of Vienna; Eurostars; DAMAN
• Investigators: Principal Investigator: Lars Erik Kristensen, The Parker Institute, Bispebjerg and Frederiksberg hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: March 14, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: MSK-2023-TSJ1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No