RHEUPP - A Rheumatological Follow-up Management App (RHEUPP)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Device: RHEUPP App; Other: Usual Follow-up

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ilka B Lineburger, MD, MSc; Phone Number: +55(51)995930345; Email: ilineburger@hcpa.edu.br

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention Group; RHEUPP App follow-up	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 Names: Other analysis: X-Ray (Sharp van der Heijde Score); Ultrasound (US10 Score); Laboratory tests; SF-36; SUS; ASES-8; eHEALS; HAQ; FACIT; FIQ; FSQ; HAQ; MDHAQ
Other: Control Group; Usual follow-up	Other: Usual Follow-up; Usual Care in Rheumatoid Arthritis Ambulatory Service; Other Names: Other analysis: X-Ray (Sharp van der Heijde Score); Ultrasound (US10 Score); Laboratory tests; SF-36; SUS; ASES-8; eHEALS; HAQ; FACIT; FIQ; FSQ; HAQ; MDHAQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Assessment of FACIT and its correlations	PMID: 15868614	From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
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)
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)

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborators: PANLAR - 2023 Innovation Award
• Investigators: Principal Investigator: Claiton V Brenol, Prof.PhD, Federal University of Health Science of Porto Alegre

Publications and helpful links

General Publications

• 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.

Helpful Links

• Citation of PANLAR Award Recipient for the project development.

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: December 29, 2023
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Rheumatoid arthritis; telehealth; mhealth app
• 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: 2023-0057

Drug and device information, study documents

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