A Randomized Controlled Clinical Trial Investigating the Effects of the Digital App Rheumabuddy4.1 in Patients With Rheumatoid Arthritis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Henning Bliddal
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Patient Global Assessment
- Status
- Recruiting
- Last Updated
- last year
Overview
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
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
Investigators
Henning Bliddal
Professor
Frederiksberg University Hospital
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.
- •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.
Outcomes
Primary Outcomes
Patient Global Assessment
Time Frame: Week 12, Week 24, change from baseline
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.
Secondary Outcomes
- Perceived Efficacy in Patient-Physician Interactions (PEPPI-5)(Week 12, Week 24, change from baseline)
- Medication Adherence (MMAS-8)(Week 12, Week 24, change from baseline)
- 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)
- Physical function (MD-HAQ)(Week 12, Week 24, change from baseline)
- Well-Being (WHO-5)(Week 12, Week 24, change from baseline)