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Rheumatoid ArthritisRHEUPPNCT06217172

RHEUPP - A Rheumatological Follow-up Management App

A study testing RHEUPP App and Usual Follow-up in people with Rheumatoid Arthritis, run by Hospital de Clinicas de Porto Alegre.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
RHEUPP App and Usual Follow-up
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
No sites listed yet
Study dates
Jan 2024to Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

Ilka B Lineburger, MD, MSc contact

+55(51)995930345

ilineburger@hcpa.edu.br

About this study

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

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:

Read more
  • 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.

Read the 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.

Being tested
RHEUPP App, Usual Follow-up
Keywords
Rheumatoid arthritis, telehealth, mhealth app
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RHEUPP AppDevice

    Also called 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

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

  • Usual Follow-upOther

    Also called 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

    Usual Care in Rheumatoid Arthritis Ambulatory Service

Study groups in NCT06217172
Study groupRoleWhat they receive
Intervention GroupOtherRHEUPP App follow-up
Receives: Device: RHEUPP App
Control GroupOtherUsual follow-up
Receives: Other: Usual Follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: From study start to 26 weeks (extended evaluation at 52 weeks)

Secondary outcomes (25)
  1. 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

    Measured: From study start to 26 weeks (extended evaluation at 52 weeks)

  2. 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.

    Measured: From study start to 26 weeks (extended evaluation at 52 weeks)

  3. 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).

    Measured: From study start to 26 weeks (extended evaluation at 52 weeks)

  4. 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).

    Measured: From study start to 26 weeks (extended evaluation at 52 weeks)

  5. 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).

    Measured: From study start to 26 weeks (extended evaluation at 52 weeks)

  6. 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.

    Measured: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)

  7. 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

    Measured: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)

  8. 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.

    Measured: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)

  9. Percentage of participants achieving remission criteria by DAS28, CDAI and SDAI

    Based on the definition of remission criteria by ACR/EULAR for each score

    Measured: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)

  10. Percentage of participants achieving remission criteria by ACR/EULAR

    Based on the definition of remission criteria by ACR/EULAR for each score

    Measured: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)

  11. Percentage of participants dropping-out from study

    Estimation based on absolute number of participants

    Measured: From study start to 26 weeks (extended evaluation at 52 weeks)

  12. 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).

    Measured: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)

  13. 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).

    Measured: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)

  14. Change from baseline in MDHAQ and its correlations

    Multi-dimensional health assessment questionnaire (MDHAQ) - PMID 16273781 [Authorized License from RWS Life Sciences]

    Measured: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)

  15. 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.

    Measured: From study start to 26 weeks (extended evaluation at 52 weeks)

  16. Change from baseline to uMARS and its correlations

    Based on the Brazilian version DOI: https://doi.org/10.33448/rsd-v12i6.42056

    Measured: From study start to 26 weeks (extended evaluation at 52 weeks)

  17. 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

    Measured: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)

  18. 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.

    Measured: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)

  19. Percentage of participants in the EULAR response criteria for "Good response" and "Moderate Response"

    Based on the definition criteria by ACR/EULAR

    Measured: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)

  20. Percentage of participants achieving Boolean remission in the ACR/EULAR criteria

    Based on the definition of Boolean remission criteria by ACR/EULAR

    Measured: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)

  21. 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.

    Measured: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)

  22. 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.

    Measured: From study start to 26 weeks (extended evaluation at 52 weeks)

  23. Assessment of FACIT and its correlations

    PMID: 15868614

    Measured: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)

  24. 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

    Measured: From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks)

  25. 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.

    Measured: From study start to 26 weeks (extended evaluation at 52 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2024
  2. Study startJan 2024 (estimated)
  3. Primary completionJul 2024 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Number of participants was considered after sample size estimation for non-inferiority margins to the outcome expected.
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06217172
Sponsor's protocol ID
2023-0057
Acronym
RHEUPP
Status last verified
Jan 2024
First submitted
29 Dec 2023
Last updated
22 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 36419141

Questions about this trial

What is this clinical trial studying?

A study testing RHEUPP App and Usual Follow-up in people with Rheumatoid Arthritis, run by Hospital de Clinicas de Porto Alegre.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ilka B Lineburger, MD, MSc (+55(51)995930345, ilineburger@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Non-inferiority of telehealth monitoring according to differences in means of CDAI (time frame: From study start to 26 weeks (extended evaluation at 52 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06217172, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.

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