RHEUPP - A Rheumatological Follow-up Management App

NCT06217172 | Unknown

• 1 other identifier: 2023-0057
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis; telehealth; mhealth app

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (25)

• Non-inferiority of telehealth monitoring according to differences in means of DAS28

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

• Differences in means of SDAI between groups

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

• Response rate to ACR20

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

• Response rate to ACR50

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

• Response rate to ACR70

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

Study Arms (2)

Intervention Group

OTHER

RHEUPP App follow-up

Device: RHEUPP App

Control Group

OTHER

Usual follow-up

Other: Usual Follow-up

Interventions

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.

Also known as: 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

Intervention Group

Usual Follow-up OTHER

Usual Care in Rheumatoid Arthritis Ambulatory Service

Also known as: 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

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• PANLAR - 2023 Innovation Award: collaborator

Related Publications (1)

• 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.

  PMID: 36419141 BACKGROUND

Related Links

• Citation of PANLAR Award Recipient for the project development.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Ultrasonography; High-Energy Shock Waves; ametantrone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Claiton V Brenol, Prof.PhD

  Federal University of Health Science of Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilka B Lineburger, MD, MSc

CONTACT

+55(51)995930345; ilineburger@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Number of participants was considered after sample size estimation for non-inferiority margins to the outcome expected.

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 22, 2024
• Study Start: January 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2025
• Last Updated: January 22, 2024

Record last verified: 2024-01