Clinical trial NCT04536844: Telehealth Follow-up in Patients With Rheumatoid Arthritis
Official title: Telehealth Follow-up in Patients With Rheumatoid Arthritis. A Noninferiority Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Treatment Compliance
Lead sponsor: Martina Hansen's Hospital
Sponsor class: OTHER
Collaborators: name: London School of Economics and Political Science
name: Helse Sor-Ost
First posted: 2020-09-03
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients suffering a flare
timeFrame: 52 weeks
Secondary outcomes:
measure: Satisfaction rates
timeFrame: 52 weeks
measure: Clinical disease activity index (CDAI)
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Sandvika
country: Norway
facility: Martina Hansens Hospital
state: Akershus
Study officials:
affiliation: Martina Hansens Hospital
name: Andreas Diamantopoulos, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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