RHEUPP - A Rheumatological Follow-up Management App

Rheumatoid Arthritis Clinical Trial

— RHEUPP  

Official title:

Use of the Multidimensional Health Assessment Questionnaire (MDHAQ/RAPID3) in Follow-up of Patients With Rheumatoid Arthritis by Telemedicine: A Non-Inferiority Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06217172
• Other study ID #: 2023-0057
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Ilka B Lineburger, MD, MSc
• Phone: +55(51)995930345
• Email: ilineburger[@]hcpa.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this Non-inferiority Randomized Clinical Trial is to evaluate the effectiveness of RHEUPP App during telehealth follow-up in a population of Rheumatoid Arthritis patients from a Tertiary Rheumatology Service in South Brazil. The main question[s] it aims to answer are: • Using RHEUPP App in telemedicine is not inferior to usual care in terms of means obtained by CDAI. Participants will be stratified by CDAI and then randomized 1:1 for intervention or control group. They will be evaluated at study starting, in 3 and 6 months, an extended evaluation after 12 months of recruitment is predicted. Researchers will compare intervention and control group to detect differences between usual care and Telehealth follow-up and determine if the last is not less effective in our study population of rheumatic patients.

Description:

Participants with access to digital media will be sent a weblink for accessing the study's electronic questionnaires by electronic message or email, with a maximum interval of one week before or after your in-person consultation, according to the research participant's preference. A tablet will be made available to patients who choose to carry out the survey on the day of their in-person assessment. Participants randomized to the intervention group will receive guidance regarding the download or access to the RHEUPP application, with a period of training and adaptation to the tool, to be carried out by Social Monitor.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: December 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (18y or older)
• Rheumatoid Arthritis according to the 2010 EULAR/ACR criteria
• Access to digital media (electronic messages, e-mail)

Exclusion Criteria:

• Other rheumatological diseases (except Sjögren's Syndrome)
• Inability to understand the instrument in general or assistance from third parties (family member or caregiver) in carrying out the questionnaire at a disadvantage
• Incomplete information in data collection
• Patients with changes in their treatment in the last 4 weeks or treatment change plan at recruitment to the study.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Device:
• RHEUPP App
RHEUPP App; Monthly RAPID3 response; General recommendations for managing Flare through App and Social Monitor for appropriate orientation; 3 month consultation by telehealth.

Other:
• Usual Follow-up
Usual Care in Rheumatoid Arthritis Ambulatory Service

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	PANLAR - 2023 Innovation Award

References & Publications (1)

Lineburger IB, Brenol CV, Goularte AS, Pinheiro EP, Hirakata VN. Cross-cultural and clinical validation of the MDHAQ/RAPID3 questionnaire in electronic format for a Brazilian population of patients with rheumatoid arthritis. Adv Rheumatol. 2022 Nov 22;62(1):46. doi: 10.1186/s42358-022-00278-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-inferiority of telehealth monitoring according to differences in means of CDAI	Non-inferiority margin of -0.6 u.m defined based on a 50% of Good EULAR Response criteria (with a 10% increase for possible losses and refusals, this number should be 88). The calculation considered a non-inferiority margin of -6 u.m., a power of 80%, level of significance of 5%, difference of 0 u.m between the means and standard deviation of 10.6 u.m. (data; Non-inferiority margin of -6 u.m defined based on a 50% of Good EULAR Response criteria	From study start to 26 weeks (extended evaluation at 52 weeks)
Secondary	Non-inferiority of telehealth monitoring according to differences in means of DAS28	Non-inferiority margin of -0.6 u.m defined based on a 50% of Good EULAR Response criteria	From study start to 26 weeks (extended evaluation at 52 weeks)
Secondary	Differences in means of SDAI between groups	Simplified Disease Activity Index for Rheumatoid Arthritis (SDAI) is calculated as follows: [SDAI = SJC + TJC +PGA + EGA + CRP]. Remission is defined as an SDAI of <3.3, low disease activity as =11, moderate disease activity as =26 and high disease activity as >26.	From study start to 26 weeks (extended evaluation at 52 weeks)
Secondary	Response rate to ACR20	The ACR20 is a composite measure defined as an improvement of 20% in the number of tender and swollen joints and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).	From study start to 26 weeks (extended evaluation at 52 weeks)
Secondary	Response rate to ACR50	The ACR50 is a composite measure defined as an improvement of 50% in the number of tender and swollen joints and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).	From study start to 26 weeks (extended evaluation at 52 weeks)
Secondary	Response rate to ACR70	The ACR70 is a composite measure defined as an improvement of 70% in the number of tender and swollen joints and a 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).	From study start to 26 weeks (extended evaluation at 52 weeks)
Secondary	Changes in baseline for DAS28	The Disease Activity Score-28 for Rheumatoid Arthritis (DAS28) range from 0 to 9.4 and are calculated using tender joints, swollen joints, general health, and a laboratory measure of acute inflammation.	From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
Secondary	Changes in baseline for CDAI	The Clinical Disease Activity Index (CDAI) is based on the simple summation of the count of swollen/tender joint count of 28 joints along with patient and physician global assessment on VAS (0-10 cm) Scale for estimating disease activity. The CDAI has range from 0 to 76	From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
Secondary	Changes in baseline for SDAI	The Simplified Disease Activity Index for Rheumatoid Arthritis (SDAI) is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity [visual analogue scale (VAS) 0-10 cm] and level of C-reactive protein (mg/dl, normal <1 mg/dl). The SDAI has a range from 0 to 100.	From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
Secondary	Percentage of participants achieving remission criteria by DAS28, CDAI and SDAI	Based on the definition of remission criteria by ACR/EULAR for each score	From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
Secondary	Percentage of participants achieving remission criteria by ACR/EULAR	Based on the definition of remission criteria by ACR/EULAR for each score	From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
Secondary	Percentage of participants dropping-out from study	Estimation based on absolute number of participants	From study start to 26 weeks (extended evaluation at 52 weeks)
Secondary	Change from baseline in Physician and Patient Global Assessment (PGA-VAS)	PGA is often assessed by a single question with a 0-10 or 0-100 response. The content can vary and relates either to global health (e.g., how is health overall) or to disease activity (e.g., how active is arthritis).	From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
Secondary	Change from baseline in RAPID3 and its correlations	RAPID3 is a composite index of physical function, pain and PGA-VAS each scored 0-10, comprising a 0-30 score. Higher scores indicate poorer status. Four RAPID3 severity categories have been proposed: high (>12), moderate (6.1-12), low (3.1-6) and near remission (=3).	From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
Secondary	Change from baseline in MDHAQ and its correlations	Multi-dimensional health assessment questionnaire (MDHAQ) - PMID 16273781 [Authorized License from RWS Life Sciences]	From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
Secondary	Change from baseline to System Usability Scale (SUS) and its correlations	System Usability Scale (SUS): Lewis JR, Sauro J. The factor structure of the system usability scale. In: Lecture Notes in Computer Science (including subseries Lecture Notes in Artificial Intelligence and Lecture Notes in Bioinformatics) 94-103; 2009.	From study start to 26 weeks (extended evaluation at 52 weeks)
Secondary	Change from baseline to uMARS and its correlations	Based on the Brazilian version DOI: https://doi.org/10.33448/rsd-v12i6.42056	From study start to 26 weeks (extended evaluation at 52 weeks)
Secondary	Change from baseline to ASES-8 Questionnaire and its correlations	Measure by the Brazilian version of ASES-8 https://doi.org/10.1590/1516-3180.2018.0354071218	From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
Secondary	Change from baseline to HAQ and its correlations	Health Assessment Questionnaire (HAQ) is a tool for measuring functional status in rheumatology. Scores of 0 to 1 are generally considered to represent mild to moderate difficulty, 1 to 2 moderate to severe disability, and 2 to 3 severe to very severe disability.	From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
Secondary	Percentage of participants in the EULAR response criteria for "Good response" and "Moderate Response"	Based on the definition criteria by ACR/EULAR	From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
Secondary	Percentage of participants achieving Boolean remission in the ACR/EULAR criteria	Based on the definition of Boolean remission criteria by ACR/EULAR	From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
Secondary	Change from baseline in detection of Flare by RAPID3	Flare will be considered when the RAPID3 score increases by more than 2 points in relation to the previous score or if the current RAPID3 is greater than 4.	From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
Secondary	Correlations with clinical assessment and other scores with Flare detection by the score RAPID3	Flare on RAPID3 score will be considered if increases by more than 2 points in relation to the previous score or if the current RAPID3 is greater than 4.	From study start to 26 weeks (extended evaluation at 52 weeks)
Secondary	Assessment of FACIT and its correlations	PMID: 15868614	From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
Secondary	Assessment of FIQ and FSQ scores and its correlations	Based on the Brazilian version PMID: 23604595 / https://doi.org/10.1186/s42358-020-00139-3	From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
Secondary	Cost-effectiveness evaluation	To evaluate cost-effectiveness and added value of the instrument in routine assistance, the number of consultations or attendance needs in emergency care/emergency care for participants throughout their follow-up at the study; travel cost estimate; evaluation of the score result in the decision professional's therapy and user's perception of the use of the instrument in monitoring your rheumatological disease.	From study start to 26 weeks (extended evaluation at 52 weeks)

External Links

•   Citation of PANLAR Award Recipient for the project development.