Telehealth Follow-up in Patients With Rheumatoid Arthritis

Martina Hansen's Hospital

Status: Unknown

Conditions: Treatment Compliance; Rheumatoid Arthritis

Treatments: Device: Mobile application MyDignio (follow disease activity by assigning questionnaires to participants); Other: Conventional prescheduled follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT04536844

33172

Details and patient eligibility

About

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

Full 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.

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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220 participants in 2 patient groups, including a placebo group

Telehealth follow-up group

Experimental group

Description:

Rheumatoid arthritis patients in remission who will be followed by an electronic app

Treatment:

Device: Mobile application MyDignio (follow disease activity by assigning questionnaires to participants)

Conventional follow-up group

Placebo Comparator group

Description:

Rheumatoid arthritis patients in remission who will attend conventional prescheduled visits in the outpatient clinic

Treatment:

Other: Conventional prescheduled follow-up