Telehealth Follow-up in Patients With Rheumatoid Arthritis

Not Applicable

• Conditions: Treatment Compliance; Rheumatoid Arthritis
• Interventions: Device: Mobile application MyDignio (follow disease activity by assigning questionnaires to participants); Other: Conventional prescheduled follow-up

• Registration Number: NCT04536844
• Lead Sponsor: Martina Hansen's Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2019-11-17
• Study Start: 2020-06-15
• Study First Submitted QC: 2020-08-27
• Study First Posted: 2020-09-03
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-22
• Primary Completion: 2021-08-15
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1. >18 years
2. Fulfilling the European League against Rheumatism (EULAR) / American College of Rheumatology (ACR) 2010 classification criteria for RA
3. Being in remission (RAPID 3 score <=3)
4. Able to use the electronic app
5. Able to give informed consent

Exclusion Criteria

1. <18 years
2. Severe cognitive failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telehealth follow-up group	Mobile application MyDignio (follow disease activity by assigning questionnaires to participants)	Rheumatoid arthritis patients in remission who will be followed by an electronic app
Conventional follow-up group	Conventional prescheduled follow-up	Rheumatoid arthritis patients in remission who will attend conventional prescheduled visits in the outpatient clinic

Primary Outcome Measures

Name	Time	Method
Number of patients suffering a flare	52 weeks	comparison of the number of patients suffering a flare in each group (Flare is defined as a routine assessment of patient index data 3 (RAPID3) score \>=3)

Secondary Outcome Measures

Name	Time	Method
Satisfaction rates	52 weeks	Compare satisfaction rates (as measured by Visual analog scale (VAS) satisfaction with the follow-up procedures) among the 2 patient groups
Clinical disease activity index (CDAI)	52 weeks	CDAI for both groups at baseline and at 52 weeks

Trial Locations

Locations (1)

Martina Hansens Hospital; 🇳🇴 Sandvika, Akershus, Norway