Remote Monitoring of Axial Spondyloarthritis

Axial Spondyloarthritis Clinical Trial

— ReMonit  

Official title:

Remote Monitoring of Axial Spondyloarthritis in Specialist Healthcare Services

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05031767
• Other study ID #: REK no.:229187
• Status: Completed
• Phase: N/A
• Start date: September 7, 2021
• Est. completion date: January 31, 2024

Study information

• Verified date: February 2024
• Source: Diakonhjemmet Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The ReMonit study is a 18-months, non-inferiority randomized, controlled trial with three parallel arms to determine if two, new follow-up strategies for patients with axial spondyloarthritis (axSpA) are non-inferior in maintaining stable, low disease activity over time compared to the conventional follow-up regimen with regular hospital visits.

Description:

The trial will include Norwegian adult males and females with axial spondyloarthritis.

240 participants will be randomized 1:1:1 to either:

1. Control group: a. Usual care, i.e. conventional follow-up strategy with blood tests, patient-reported outcomes (PROs), and pre-scheduled visits at the hospital every 6th month

2. Remote monitoring: hospital health professionals (HPs) perform remote monitoring of frequent PROs, blood test results, and physical activity data available on a digital platform

3. Patient-initiated care: no pre-scheduled visits or remote monitoring

The study has 18 months follow-up. We will use a 15% non-inferiority margin.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or non-pregnant, non-nursing female >18 years of age at screening

• Patients with a diagnosis of axSpA who fulfil the diagnostic Assessment of SpondyloArthritis International Society (ASAS) criteria for axSpA

• Stable medical treatment with TNFi the last 6 months

• Low disease activity (ASDAS<2.1) at inclusion

• Capable of understanding the Norwegian language and of signing an informed consent form

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)

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 Alanine Transaminase (ALT) >3x 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

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Spondylarthritis
• Spondylitis

Intervention

Other:
• Usual care
Conventional follow-up strategy with blood tests, patient-reported outcomes, and pre-scheduled visits at the hospital every 6th month. Continue using medical treatment with tumour necrosis factor inhibitors (TNFi). Patients will be instructed to use NSAIDs should they experience minor worsening of symptoms, but if the patients experience significant symptom worsening and suspect a severe disease worsening (flare) or adverse events, they will be instructed contact the hospital.
• Remote monitoring
Hospital health professionals perform remote monitoring of frequent patient-reported outcomes, blood test results, and physical activity data available on a digital platform. Continue using medical treatment with tumour necrosis factor inhibitors (TNFi). Patients will be instructed to use NSAIDs should they experience minor worsening of symptoms, but if the patients experience significant symptom worsening and suspect a severe disease worsening (flare) or adverse events, they will be instructed contact the hospital .
• Patient-initiated care
No pre-scheduled visits or remote monitoring. Continue using medical treatment with tumour necrosis factor inhibitors (TNFi). Patients will be instructed to use NSAIDs should they experience minor worsening of symptoms, but if the patients experience significant symptom worsening and suspect a severe disease worsening (flare) or adverse events, they will be instructed contact the hospital.

Locations

Country	Name	City	State
Norway	Diakonhjemmet Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Diakonhjemmet Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low disease activity at follow-up	The proportion of patients with low disease activity (defined as ASDAS <2.1) at the 6-months follow-up	6 months
Primary	Low disease activity at follow-up	The proportion of patients with low disease activity (defined as ASDAS <2.1) at the 12- months follow-up	12 months
Primary	Low disease activity at follow-up	The proportion of patients with low disease activity (defined as ASDAS <2.1) at the 18-months follow-up	18 months
Secondary	Ankylosing Spondylitis Disease Activity Score (ASDAS)	Ankylosing Spondylitis Disease Activity Score (ASDAS) is a clinical measure of disease activity calculated from four patient-reported outcomes (PROs) and C-reactive Protein (CRP) (or erythrocyte sedimentation rate (ESR) if CRP is not available). The formula for calculating ASDAS CRP = 0.12 × back pain + 0.06 × duration of morning stiffness + 0.11 × patient global + 0.07 × peripheral pain/swelling + 0.58×Ln(CRP + 1)). Higher values indicate worse outcome.	Baseline, 6, 12 and 18 months
Secondary	Ankylosing Spondylitis Disease Activity Score (ASDAS)	Monthly for a subgroup among the Remote monitoring group. ASDAS is a clinical measure of disease activity calculated from four PROs and CRP (or ESR if CRP is not available). The formula for calculating ASDAS CRP = 0.12 × back pain + 0.06 × duration of morning stiffness + 0.11 × patient global + 0.07 × peripheral pain/swelling + 0.58×Ln(CRP + 1)). Higher values indicate worse outcome.	Every month, maximum 18 months
Secondary	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	Patient-reported disease activity last 7 days on 6 items using a numeric rating scale (NRS) 0-10. The score is the sum (of the first four individual questions and the mean of questions five and six) divided by five. The sum score range 0-10; higher value indicate worse outcome.	Baseline, 6, 12 and 18 months
Secondary	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	Monthly reported by the Remote monitoring group if disease worsening. Patient-reported disease activity last 7 days on 6 items using a NRS 0-10. The score is the sum (of the first four individual questions and the mean of questions five and six) divided by five. The sum score range 0-10; higher value indicate worse outcome.	Every month, maximum 18 months
Secondary	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	Reported every third month by the Patient-initiated care group if disease worsening. Patient-reported disease activity last 7 days on 6 items using a NRS 0-10. The score is the sum (of the first four individual questions and the mean of questions five and six) divided by five. The sum score range 0-10; higher value indicate worse outcome.	Baseline, 3, 6, 9, 12, 15 and 18 months
Secondary	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	Reported monthly by the a subgroup among the Remote monitoring group. Patient-reported disease activity last 7 days on 6 items using a NRS 0-10. The score is the sum (of the first four individual questions and the mean of questions five and six) divided by five. The sum score range 0-10; higher value indicate worse outcome.	Every month, maximum 18 months
Secondary	C-Reactive Protein (CRP)	CRP measured at home in a subgroup among the Remote monitoring group	Every month, maximum 18 months
Secondary	Patient global assessment of disease activity	Patient-reported disease activity last 7 days on a NRS 0-10 ; higher value indicate worse outcome	Baseline, 6, 12 and 18 months
Secondary	Patient global assessment of disease activity	Monthly reported by the Remote monitoring group. Patient-reported disease activity last 7 days on a NRS 0-10 ; higher value indicate worse outcome	Every month, maximum 18 months
Secondary	Patient global assessment of disease activity	Reported every third month by the Patient-initiated care group: Patient-reported disease activity last 7 days on a NRS 0-10 ; higher value indicate worse outcome	3, 6, 9, 12, 15 and 18 months
Secondary	Patient-reported flare	Patient-reported experience of a significant worsening of symptoms (reflecting a flare in disease activity), response options: no, yes, uncertain. If yes or uncertain, they will be asked which date the flare occurred and the number of days it lasted.	6, 12 and 18 months
Secondary	Patient-reported flare	Monthly reported by the Remote monitoring group. Patient-reported experience of a significant worsening of symptoms (reflecting a flare in disease activity), response options: no, yes, uncertain. If yes or uncertain, they will be asked which date the flare occurred and the number of days it lasted.	Every month, maximum 18 months
Secondary	Patient-reported flare	Reported every third month by the Patient-initiated care group. Patient-reported experience of a significant worsening of symptoms (reflecting a flare in disease activity), response options: no, yes, uncertain. If yes or uncertain, they will be asked which date the flare occurred and the number of days it lasted.	3, 6, 9, 12, 15 and 18 months
Secondary	Bath Ankylosing Spondylitis Functional Index (BASFI)	10 item questionnaire (NRS 0-10) used to assess disease activity last 7 days. The score is the sum of each individual question divided by 10, higher value indicate worse outcome.	Baseline, 6, 12 and 18 months
Secondary	Activity Impairment	Item no.6 from Work Productivity and Activity Impairment (WPAI): self-reported activity impairment on a NRS 0-10; higher value indicate worse outcome.	Baseline, 6, 12 and 18 months
Secondary	Patient-reported global change in disease activity	Single item with seven-point response scale ranging from "Much worse" to "Much better".	6, 12 and 18 months
Secondary	Patient-reported global change in activity impairment	Single item with seven-point response scale ranging from "Much worse" to "Much better".	6, 12 and 18 months
Secondary	Pain (general)	Self-reported pain level last 7 days hours on a NRS 0-10; higher value indicate worse outcome.	Baseline, 6, 12 and 18 months
Secondary	Joint pain	Self-reported joint pain level last 7 days hours on a NRS 0-10; higher value indicate worse outcome.	Baseline, 6, 12 and 18 months
Secondary	Sleep impairment	1 item from Pittsburgh Sleep Quality Index, self-reported sleep impairment in last month due to pain with 4 response categories ranging "Not during the past month" to "Three or more times a week" ; higher value indicate worse outcome.	Baseline, 6, 12 and 18 months
Secondary	Patient satisfaction with care	1 item with five point response options ranging from "Very satisfied" to "Very dissatisfied", higher value indicate better outcome	Baseline, 6, 12 and 18 months
Secondary	Daily steps	Remote monitoring and Patient-initiated care groups, number of steps during daytime captured by wearing a smartwatch	Through study completion, maximum 18 months
Secondary	Mean pulse level	Remote monitoring and Patient-initiated care groups, mean pulse level during daytime captured by wearing a smartwatch	Through study completion, maximum 18 months
Secondary	Euro Quality of Life 5 Dimensions 5 Levels (EQ5D-5L)	6 item utility instrument for measurement of health related quality of life, 5 first items with 5 response categories, item no.6: self-reported health status on a 0-100 mm scale	Baseline, 6, 12 and 18 months
Secondary	Concomitant medication	Self-reported use of NSAIDs and analgesics and national register data from The Norwegian Prescription Register	Baseline, 6, 12 and 18 months
Secondary	Swollen joint count	For the Control group, examiner assessed metacarpophalangeal (MCP) 1-5, proximal interphalangeal (PIP) 1-5, wrists, elbows, shoulders, ankles, forefeet	Baseline, 6, 12 and 18 months
Secondary	Swollen joint count	At extra visits/withdrawals/early discontinuation in the Remote monitoring and Patient-initiated care groups, For the Control group, examiner assessed MCP 1-5, PIP 1-5, wrists, elbows, shoulders, ankles, forefeet	Baseline, through study completion, and 18 months
Secondary	Tender joint count	For the Control group, examiner assessed MCP 1-5, PIP 1-5, wrists, elbows, shoulders, ankles, forefeet	Baseline, 6, 12 and 18 months
Secondary	Tender joint count	At extra visits/withdrawals/early discontinuation in the Remote monitoring and Patient-initiated care groups, For the Control group, examiner assessed MCP1-5, PIP 1-5, wrists, elbows, shoulders, ankles, forefeet	Baseline, through study completion, and 18 months
Secondary	Heel enthesitis	For the Control group, the presence of heel enthesitis is examined clinically by a health professional. Scored as not present/present right heel/present left heel/present both heels.	Baseline, 6, 12 and 18 months
Secondary	Heel enthesitis	At extra visits/withdrawals/early discontinuation in the Remote monitoring and Patient-initiated care groups, , the presence of heel enthesitis is examined clinically by a health professional. Scored as not present/present right heel/present left heel/present both heels.	Baseline, through study completion, and 18 months
Secondary	Costs related to hospital visits	Self-reported way of transport to the hospital; walking or bicycling/private car/public transportation/taxi/airplane/other.	Baseline
Secondary	Costs related to hospital visits	Self-reported travel distance in kilometres to the hospital.	Baseline
Secondary	The need to take time off work for hospital visits or video consultations	If in paid work, the need to take time off from work is indicated as yes or no.	Baseline
Secondary	Health care utilization	Self-reported health care use and national register data on consultations and treatment in secondary and primary health care	Baseline, 6, 12 and 18 months
Secondary	Extra visits, telephone and video consultations	Number of extra visits to the hospital or video consultations with a health care provider	Through study completion, maximum 18 months
Secondary	Withdrawals/Early discontinuation	Number of withdrawals/early discontinuation	Through study completion, maximum 18 months
Secondary	Adverse events	Number of adverse events, serious adverse events, and withdrawals because of adverse events.	Through study completion, maximum 18 months
Secondary	Patient-reported self-efficacy for using different digital devices, secure login and digital health services measured on a Likert scale	Self-efficacy/confidence in using smartphone, tablet, computer, app's, secure login and digital health services. 6 items with Likert scale response categories: Never used, Very bad, Bad, Neither good nor bad, Good, Very good. Score range 1-5; higher scores indicate higher self-efficacy.	Baseline
Secondary	eHealth literacy	20 items from 4 domains of the eHealth Literacy Questionnaire (eHLQ). Four point response scale, sum domain score range 1-4. Lower scores indicate lower eHealth literacy.	Baseline
Secondary	Body signs and symptoms	To what degree do you understand your body's signs and symptoms. Single item, 4-point Likert scale (not at all - to a large degree + do not know-option)	18 months
Secondary	Patient satisfaction with remote monitoring or patient-initiated care	Service User Technology Acceptability Questionnaire (SUTAQ) reported by the Remote monitoring group. 22 items in 5 subscales. Score range 1-6. Higher scores in subscales 1,2 and 5/lower scores in subscales 3 and 4 indicate higher acceptability with telehealth.	18 months
Secondary	Patient satisfaction with remote monitoring or patient-initiated care	Service User Technology Acceptability Questionnaire (SUTAQ) reported by the Patient-initiated care group. 3 of 22 items: #1, #10 and #11. Score range 1-6. Higher scores in indicate higher acceptability with telehealth.	18 months
Secondary	Preferred follow-up strategy	One item on whether the preferred follow-up strategy would be Remote monitoring or Patient-initated care reported by the two intervention groups only.	18 months