Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid arthritis, telehealth, mhealth app
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.
Interventions
DEVICERHEUPP App
RHEUPP App; Monthly RAPID3 response; General recommendations for managing Flare through App and Social Monitor for appropriate orientation; 3 month consultation by telehealth.
OTHERUsual Follow-up
Usual Care in Rheumatoid Arthritis Ambulatory Service
Sponsors
PANLAR - 2023 Innovation Award
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Number of participants was considered after sample size estimation for non-inferiority margins to the outcome expected.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-inferiority of telehealth monitoring according to differences in means of CDAI | From study start to 26 weeks (extended evaluation at 52 weeks) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in means of SDAI between groups | From study start to 26 weeks (extended evaluation at 52 weeks) | 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. |
| Response rate to ACR20 | From study start to 26 weeks (extended evaluation at 52 weeks) | 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). |
| Response rate to ACR50 | From study start to 26 weeks (extended evaluation at 52 weeks) | 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). |
| Response rate to ACR70 | From study start to 26 weeks (extended evaluation at 52 weeks) | 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). |
| Changes in baseline for DAS28 | From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks) | 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. |
| Changes in baseline for CDAI | From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks) | 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 |
| Changes in baseline for SDAI | From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks) | 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. |
| Percentage of participants achieving remission criteria by DAS28, CDAI and SDAI | From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks) | Based on the definition of remission criteria by ACR/EULAR for each score |
| Percentage of participants achieving remission criteria by ACR/EULAR | From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks) | Based on the definition of remission criteria by ACR/EULAR for each score |
| Percentage of participants dropping-out from study | From study start to 26 weeks (extended evaluation at 52 weeks) | Estimation based on absolute number of participants |
| Change from baseline in Physician and Patient Global Assessment (PGA-VAS) | From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks) | 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). |
| Change from baseline in RAPID3 and its correlations | From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks) | 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). |
| Non-inferiority of telehealth monitoring according to differences in means of DAS28 | From study start to 26 weeks (extended evaluation at 52 weeks) | Non-inferiority margin of -0.6 u.m defined based on a 50% of Good EULAR Response criteria |
| Change from baseline to System Usability Scale (SUS) and its correlations | From study start to 26 weeks (extended evaluation at 52 weeks) | 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. |
| Change from baseline to uMARS and its correlations | From study start to 26 weeks (extended evaluation at 52 weeks) | Based on the Brazilian version DOI: https://doi.org/10.33448/rsd-v12i6.42056 |
| Change from baseline to ASES-8 Questionnaire and its correlations | From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks) | Measure by the Brazilian version of ASES-8 https://doi.org/10.1590/1516-3180.2018.0354071218 |
| Change from baseline to HAQ and its correlations | From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks) | 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. |
| Percentage of participants in the EULAR response criteria for Good response and Moderate Response | From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks) | Based on the definition criteria by ACR/EULAR |
| Percentage of participants achieving Boolean remission in the ACR/EULAR criteria | From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks) | Based on the definition of Boolean remission criteria by ACR/EULAR |
| Change from baseline in detection of Flare by RAPID3 | From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks) | 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. |
| Correlations with clinical assessment and other scores with Flare detection by the score RAPID3 | From study start to 26 weeks (extended evaluation at 52 weeks) | 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. |
| Assessment of FACIT and its correlations | From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks) | PMID: 15868614 |
| Assessment of FIQ and FSQ scores and its correlations | From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks) | Based on the Brazilian version PMID: 23604595 / https://doi.org/10.1186/s42358-020-00139-3 |
| Cost-effectiveness evaluation | From study start to 26 weeks (extended evaluation at 52 weeks) | 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. |
| Change from baseline in MDHAQ and its correlations | From study start, 13 weeks and 26 weeks (extended evaluation at 52 weeks) | Multi-dimensional health assessment questionnaire (MDHAQ) - PMID 16273781 \[Authorized License from RWS Life Sciences\] |
Contacts
Primary ContactIlka B Lineburger, MD, MSc
Outcome results
None listed