RHEUPP - A Rheumatological Follow-up Management App

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Intervention Group

RHEUPP App follow-up

Group Type OTHER

RHEUPP App

Intervention Type DEVICE

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

Control Group

Usual follow-up

Group Type OTHER

Usual Follow-up

Intervention Type OTHER

Usual Care in Rheumatoid Arthritis Ambulatory Service

Interventions

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RHEUPP App

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

Intervention Type DEVICE

Usual Follow-up

Usual Care in Rheumatoid Arthritis Ambulatory Service

Intervention Type OTHER

Other Intervention Names

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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 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

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No