Clinical trial NCT05496855: Remote Care in People With Rheumatoid Arthritis
Official title: Can Machine Learning and Patient-reported Outcomes be Used in Remote Care in People With Rheumatic Diseases
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: remote care
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled non-inferiority trial
Primary purpose: TREATMENT

Brief summary: This study is a 24-months, non-inferiority randomized, controlled trial with two parallel arms to determine if a new follow-up strategy for patients with RA is non-inferior in maintaining comprehensive disease control measured as simultaneous maintenance of structural, functional and clinical treatment target at 2-year follow-up compared to the conventional follow-up regimen with regular hospital visits.

Detailed description: The study will include Norwegian adult males and females with rheumatoid arthritis. Eligible patients that consent to participation will be randomized to two groups:

* Control group: conventional follow-up strategy with blood tests, patient-reported outcomes (PROs), and pre-scheduled visits at the hospital every 6th month.
* Remote monitoring: monthly remote monitoring of PROs and triage of patients using an algorithm will guide healthcare providers in scheduling patients for a video consultation or face-to-face hospital visits.

Participants will be followed for 24 months. Primary outcome is proportionn maintaining comprehensive disease control measured as simultaneous maintenance of structural, functional and clinical treatment target at 2-year follow-up1.

* Structural: Assessed with radiographs of hands and feet according to the van der Heijde modified Sharpe score (subscores for erosions (0-280) and joint space narrowing (0-168)), with a total range of 0-448. Maintenance of structural treatment target is defined as change in total score \<1 unit/year (\<2 units from inclusion to 2-year follow-up).
* Functional: Measured by Modified Health Assessment Questionnaire (MHAQ) measured on a scale from 0.00 to 3.00, where a change of 0.25 is considered clinical important3. Maintenance of functional treatment target is defined as a worsening \<0.25 from inclusion to 2-year follow-up.
* Clinical: Measured by DAS28, categorized into remission (\<2.6), low disease activity (2.6 to ≤3.2), moderate disease activity (3.2 to ≤5.1) and high disease activity (\>5.1). Maintenance of clinical treatment target is defined disease activity category at 2-year follow-up ≤ baseline category.

We will use a 15% non-inferiority margin.

The study will comprise an internal pilot study the first 6 months for all participants in the intervention group.

The study will also include qualitative research including semi-structured interviews and observations of patients in the intervention group and health professionals involved in the study. The interviews will explore experiences with remote monitoring and video consultations.

Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant, non-nursing female ≥18 years of age at screening
* Patients with a diagnosis of RA who fulfil the 2010 ACR/EULAR diagnostic criteria24 (see Appendix 5, 10.4)
* Medical treatment with cs/ts/bDMARDs (incl. prednisolone) considered stable by the healthcare provider the last 6 months
* Low disease activity or remission (CDAI\<10 / DAS28\<3.2) at inclusion
* \<2 swollen joints
* Not deemed inappropriate for remote monitoring by the healthcare provider
* Capable of understanding and signing an informed consent form
* Access to a smartphone or tablet
* Able to speak and understand Norwegian language

Exclusion Criteria:

Medical conditions:

* Major co-morbidities, such as severe malignancies, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease (NYHA class III or IV), severe respiratory diseases, and/or cirrhosis.
* Indications of active tuberculosis (TB)
* Treated with intravenous DMARD (e.g., rituximab and infliximab)

Diagnostic assessments:

* Abnormal renal function, defined as serum creatinine \>142 µmol/L in female and \>168 µmol/L in male, or glomerular filtration rate (GFR) \<40 mL/min/1.73 m2
* Abnormal liver function (defined as Aspartate Transaminate (AST)/Alanine Transaminase (ALT) \>3 x upper normal limit), active or recent hepatitis
* Leukopenia and/or thrombocytopenia

Other:

* Pregnancy and/or breastfeeding (current at screening or planned within the duration of the study)
* Severe psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible.
* Deemed unsuitable for remote monitoring by medical doctor

Primary outcomes:
measure: Proportion maintaining comprehensive disease control
timeFrame: Baseline and 2 years
Secondary outcomes:
measure: Change in joint damage progression
timeFrame: Baseline and 2 years
measure: Self-reported disease activity (intervention group)
timeFrame: Monthly until 2 years
measure: Self-reported disease activity (control group)
timeFrame: Baseline, 6 months, 12 months, 18 months and 2 years
measure: Health-related quality of life
timeFrame: Baseline, 6 months, 12 months, 18 months and 2 years
measure: Proportion in remission/low disease activity (CDAI)
timeFrame: Baseline and 2 years
measure: Proportion in remission/low disease activity (DAS28)
timeFrame: Baseline and 2 years
measure: Disease activity in conjunction with consultation (DAS28)
timeFrame: Any consultation from baseline to 2 years
measure: Disease activity in conjunction with consultation (CDAI)
timeFrame: Any consultation from baseline to 2 years
measure: Health care utilization
timeFrame: Baseline, 6 months, 12 months, 18 months, 2 years
measure: Patient-reported disease flares (intervention group)
timeFrame: Every month until 2 years
measure: Patient-reported disease flares (control group)
timeFrame: 6 months, 12 months, 18 months, 2 years
measure: Adverse events
timeFrame: Through study completion, maximum 2 years
measure: Number of consultations/contacts at the hospital
timeFrame: From baseline to 2 years
measure: Activity impairment (intervention group)
timeFrame: Baseline and monthly until 2 years
measure: Activity impairment (control group)
timeFrame: Baseline, 6 months, 12 months, 18 months, 2 years
measure: Costs related to hospital visits
timeFrame: Baseline
measure: The need to take time off for hospital visits or video consultation
timeFrame: Baseline
measure: C-Reactive Protein (CRP) (intervention group)
timeFrame: Baseline, 3, 6, 9, 12, 15, 18, 21 months and 2 years
measure: C-Reactive Protein (CRP) (control group)
timeFrame: Baseline, 6 months, 12 months, 18 months and 2 years
measure: C-Reactive Protein (CRP) (intervention group)
timeFrame: Monthly until 2 years
measure: Modified Health Assessment Questionnaire (MHAQ)
timeFrame: Baseline, 6 months, 12 months, 18 months, 2 years
measure: PROMIS Physical function
timeFrame: Baseline, 6 months, 12 months, 18 months, 2 years
measure: Pain (intervention group)
timeFrame: Baseline and monthly until 2 years
measure: Pain (control group)
timeFrame: Baseline, 6 months, 12 months, 18 months, 2 years
measure: Joint pain (intervention group)
timeFrame: Baseline and monthly until 2 years
measure: Joint pain (control group)
timeFrame: Baseline, 6 months, 12 months, 18 months, 2 years
measure: Sleep impairment
timeFrame: Baseline, 6 months, 12 months, 18 months, 2 years
measure: Medication use
timeFrame: Baseline, 6 months, 12 months, 18 months, 2 years
measure: Swollen joint count
timeFrame: Baseline, any hospital visits, 2 years
measure: Tender joint count
timeFrame: Baseline, any hospital visits, 2 years
measure: Extra visits, telephone and video consultations
timeFrame: Through study completion, maximum 2 years
measure: Withdrawals/early discontinuation
timeFrame: Through study completion, maximum 2 years
measure: Physical activity
timeFrame: Baseline, 6 months, 12 months, 18 months, 2 years
measure: Fatigue
timeFrame: Baseline, 6 months, 12 months, 18 months, 2 years
measure: Patient acceptable symptom state
timeFrame: Baseline, 6 months, 12 months, 18 months, 2 years
measure: eHealth literacy
timeFrame: Baseline
measure: Patient-reported self-efficacy for using different digital devices, secure login and digital health services
timeFrame: Baseline
measure: Patient satisfaction with care
timeFrame: Baseline, 6 months, 12 months, 18 months, 2 year
measure: Patient satisfaction with remote monitoring
timeFrame: 2 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital
Study officials:
affiliation: Diakonhjemmet Hospital
name: Anne Therese Tveter, PhD
role: PRINCIPAL_INVESTIGATOR
References: