NCT04536844

Telehealth Follow-up in Patients With Rheumatoid Arthritis

Telehealth Follow-up in Patients With Rheumatoid Arthritis. A Noninferiority Randomized Control Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Vestre Viken Hospital Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the present project is to test the effect of a customized Patient-Reported-Outcome (PRO)-based telehealth follow-up compared to a conventional pre-scheduled outpatient follow-up to monitor disease activity and expenses associated with the follow-up in patients with RA

Detailed description

Rheumatoid arthritis (RA) is a chronic inflammatory joint disease with a high burden both for the patient and society. Outcomes for the individuals living with RA have been improved and the majority of RA patients are now in remission or low disease activity status. RA patients continue to be followed up by pre-scheduled visits, which may compromise accessibility for the sickest and thus, quality of care. The introduction of patient-initiated follow-up leads to a reduction in the use of outpatient clinic services without compromising outcomes. Self-monitoring and remote patient monitoring are facilitated by electronic innovative health tools. Among RA patients with low disease activity or remission, a Patient-Reported Outcome-based telehealth follow-up for tight control of disease activity in RA can achieve similar disease control as conventional outpatient follow-up and is likely to reduce the costs. Thus, the main objective of the present project is to test the effect of a customized PRO-based telehealth follow-up compared to a conventional prescheduled outpatient follow-up to monitor disease activity and expenses associated with the follow-up in Norwegian RA patients.

Conditions

• Rheumatoid Arthritis
• Treatment Compliance

Interventions

Type	Name	Description
DEVICE	Mobile application MyDignio (follow disease activity by assigning questionnaires to participants)	An electronic application available both on Apple store and Android play which the patients can download for free will be used to collect data from the Telehealth follow up group. This group will be compared to conventional outpatient clinic follow-up group.
OTHER	Conventional prescheduled follow-up	Patients will be followed in the outpatient clinic by prescheduled follow-up

Timeline

• Start date: 2020-06-15
• Primary completion: 2021-08-15
• Completion: 2021-12-01
• First posted: 2020-09-03
• Last updated: 2020-10-22

Locations

1 site across 1 country: Norway