Telehealth Follow-up in Patients With Rheumatoid Arthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-15

Study Completion Date

2021-12-31

Brief Summary

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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

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Detailed Description

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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

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Rheumatoid Arthritis Treatment Compliance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a pragmatic noninferiority randomized controlled trial (RCT) in Norwegian RA patients in clinical remission (based on RAPID3 score). The patients will be allocated to 2 groups. One group will be followed up by an electronic app, while the second group will attend conventional prescheduled visits in the outpatient clinic of Martina Hansens Hospital. A computer-generated random number sequence will be used for the randomization of the RA patients.

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Telehealth follow-up group

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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.

Conventional follow-up group

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

Group Type PLACEBO_COMPARATOR

Conventional prescheduled follow-up

Intervention Type OTHER

Patients will be followed in the outpatient clinic by prescheduled follow-up

Interventions

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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.

Intervention Type DEVICE

Conventional prescheduled follow-up

Patients will be followed in the outpatient clinic by prescheduled follow-up

Intervention Type OTHER

Eligibility Criteria

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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