RHEUPP - A Rheumatological Follow-up Management App

Hospital de Clinicas de Porto Alegre

Status: Not yet enrolling

Conditions: Rheumatoid Arthritis

Treatments: Device: RHEUPP App; Other: Usual Follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT06217172

2023-0057

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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88 participants in 2 patient groups

Intervention Group

Other group

Description:

RHEUPP App follow-up

Treatment:

Device: RHEUPP App

Control Group

Other group

Description:

Usual follow-up

Treatment:

Other: Usual Follow-up