Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06217172
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-22
First Post:
2023-12-29
Brief Title:
RHEUPP - A Rheumatological Follow-up Management App
Sponsor:
Hospital de Clinicas de Porto Alegre
Organization:
Hospital de Clinicas de Porto Alegre
Study Overview
Official Title:
Use of the Multidimensional Health Assessment Questionnaire MDHAQRAPID3 in Follow-up of Patients With Rheumatoid Arthritis by Telemedicine A Non-Inferiority Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RHEUPP
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 questions 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 11 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
The main questions 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 11 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 studys 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 participants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None