Telehealth Follow-up in Patients With Rheumatoid Arthritis

Study Overview
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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

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.

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

Conditions
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Rheumatoid Arthritis, Treatment Compliance

Intervention / Treatment
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* Device: Mobile application MyDignio (follow disease activity by assigning questionnaires to participants)
* Other: Conventional prescheduled follow-up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years Fulfilling the European League against Rheumatism (EULAR) / American College of Rheumatology (ACR) 2010 classification criteria for RA Being in remission (RAPID 3 score <=3) Able to use the electronic app Able to give informed consent Exclusion Criteria: <18 years Severe cognitive failure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telehealth follow-up group<br>Rheumatoid arthritis patients in remission who will be followed by an electronic app | Device: Mobile application MyDignio (follow disease activity by assigning questionnaires to participants)<br>* 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.<br>|
| Placebo Comparator: Conventional follow-up group<br>Rheumatoid arthritis patients in remission who will attend conventional prescheduled visits in the outpatient clinic | Other: Conventional prescheduled follow-up<br>* Patients will be followed in the outpatient clinic by prescheduled follow-up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients suffering a flare | 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) | 52 weeks | 

Secondary Outcome Measures

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