Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337786
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-03-14
Brief Title:
Investigating the Effects of the Digital App Rheumabuddy41 in a Clinical Set-up in Patients With Rheumatoid Arthritis
Sponsor:
Henning Bliddal
Organization:
Frederiksberg University Hospital
Study Overview
Official Title:
A Register Controlled Clinical Trial Investigating the Effects of the Digital App Rheumabuddy41 in Patients With Rheumatoid Arthritis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 whats 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 RheumaBuddy41 RB41 and the ability to provide support and increase quality of life in patients with RA
There is a discrepancy in the understanding of whats 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 RheumaBuddy41 RB41 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 swollentender jointsThis 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 RB41 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 RheumaBuddy41 RB41 and the ability to provide support and increase quality of life in patients with RA
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 swollentender jointsThis 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 RB41 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 RheumaBuddy41 RB41 and the ability to provide support and increase quality of life in patients with RA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None