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| Name | Class |
|---|---|
| PANLAR - 2023 Innovation Award | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Other | RHEUPP App follow-up |
|
| Control Group | Other | Usual follow-up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RHEUPP App | Device | RHEUPP App; Monthly RAPID3 response; General recommendations for managing Flare through App and Social Monitor for appropriate orientation; 3 month consultation by telehealth. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ilka B Lineburger, MD, MSc | Contact | +55(51)995930345 | ilineburger@hcpa.edu.br |
| Name | Affiliation | Role |
|---|---|---|
| Claiton V Brenol, Prof.PhD | Federal University of Health Science of Porto Alegre | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36419141 | Background | 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. |
| Label | URL |
|---|---|
| Citation of PANLAR Award Recipient for the project development. | View source |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D019220 | High-Energy Shock Waves |
| C020182 | ametantrone |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D000069453 | Ultrasonic Waves |
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Number of participants was considered after sample size estimation for non-inferiority margins to the outcome expected.
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|
| Usual Follow-up | Other | Usual Care in Rheumatoid Arthritis Ambulatory Service |
|
|
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) |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D013016 |
| Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
| D055585 | Physical Phenomena |