Clinical trial NCT06217172: RHEUPP - A Rheumatological Follow-up Management App
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
telehealth
mhealth app
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: PANLAR - 2023 Innovation Award
First posted: 2024-01-22
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Number of participants was considered after sample size estimation for non-inferiority margins to the outcome expected.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Non-inferiority of telehealth monitoring according to differences in means of CDAI
timeFrame: From study start to 26 weeks (extended evaluation at 52 weeks)
Secondary outcomes:
measure: Non-inferiority of telehealth monitoring according to differences in means of DAS28
timeFrame: From study start to 26 weeks (extended evaluation at 52 weeks)
measure: Differences in means of SDAI between groups
timeFrame: From study start to 26 weeks (extended evaluation at 52 weeks)
measure: Response rate to ACR20
timeFrame: From study start to 26 weeks (extended evaluation at 52 weeks)
measure: Response rate to ACR50
timeFrame: From study start to 26 weeks (extended evaluation at 52 weeks)
measure: Response rate to ACR70
timeFrame: From study start to 26 weeks (extended evaluation at 52 weeks)
measure: Changes in baseline for DAS28
timeFrame: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
measure: Changes in baseline for CDAI
timeFrame: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
measure: Changes in baseline for SDAI
timeFrame: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
measure: Percentage of participants achieving remission criteria by DAS28, CDAI and SDAI
timeFrame: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
measure: Percentage of participants achieving remission criteria by ACR/EULAR
timeFrame: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
measure: Percentage of participants dropping-out from study
timeFrame: From study start to 26 weeks (extended evaluation at 52 weeks)
measure: Change from baseline in Physician and Patient Global Assessment (PGA-VAS)
timeFrame: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
measure: Change from baseline in RAPID3 and its correlations
timeFrame: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
measure: Change from baseline in MDHAQ and its correlations
timeFrame: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
measure: Change from baseline to System Usability Scale (SUS) and its correlations
timeFrame: From study start to 26 weeks (extended evaluation at 52 weeks)
measure: Change from baseline to uMARS and its correlations
timeFrame: From study start to 26 weeks (extended evaluation at 52 weeks)
measure: Change from baseline to ASES-8 Questionnaire and its correlations
timeFrame: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
measure: Change from baseline to HAQ and its correlations
timeFrame: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
measure: Percentage of participants in the EULAR response criteria for "Good response" and "Moderate Response"
timeFrame: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
measure: Percentage of participants achieving Boolean remission in the ACR/EULAR criteria
timeFrame: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
measure: Change from baseline in detection of Flare by RAPID3
timeFrame: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
measure: Correlations with clinical assessment and other scores with Flare detection by the score RAPID3
timeFrame: From study start to 26 weeks (extended evaluation at 52 weeks)
measure: Assessment of FACIT and its correlations
timeFrame: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
measure: Assessment of FIQ and FSQ scores and its correlations
timeFrame: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)
measure: Cost-effectiveness evaluation
timeFrame: From study start to 26 weeks (extended evaluation at 52 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Health Science of Porto Alegre
name: Claiton V Brenol, Prof.PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.