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Remote Monitoring of Axial Spondyloarthritis (ReMonit)

Primary Purpose

Axial Spondyloarthritis

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Usual care
Remote monitoring
Patient-initiated care
Sponsored by
Diakonhjemmet Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Axial Spondyloarthritis focused on measuring rheumatic diseases, musculoskeletal diseases, joint diseases, arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Diakonhjemmet Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Usual care

Remote monitoring

Patient-initiated care

Arm Description

Conventional current follow-up strategy

Remote monitoring by health professionals at the hospital

No pre-scheduled visits or remote monitoring.

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
C-Reactive Protein (CRP)
CRP measured at home in a subgroup among the Remote monitoring group
Patient global assessment of disease activity
Patient-reported disease activity last 7 days on a NRS 0-10 ; higher value indicate worse outcome
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
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
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.
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.
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.
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.
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.
Patient-reported global change in disease activity
Single item with seven-point response scale ranging from "Much worse" to "Much better".
Patient-reported global change in activity impairment
Single item with seven-point response scale ranging from "Much worse" to "Much better".
Pain (general)
Self-reported pain level last 7 days hours on a NRS 0-10; higher value indicate worse outcome.
Joint pain
Self-reported joint pain level last 7 days hours on a NRS 0-10; higher value indicate worse outcome.
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.
Patient satisfaction with care
1 item with five point response options ranging from "Very satisfied" to "Very dissatisfied", higher value indicate better outcome
Daily steps
Remote monitoring and Patient-initiated care groups, number of steps during daytime captured by wearing a smartwatch
Mean pulse level
Remote monitoring and Patient-initiated care groups, mean pulse level during daytime captured by wearing a smartwatch
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
Concomitant medication
Self-reported use of NSAIDs and analgesics and national register data from The Norwegian Prescription Register
Swollen joint count
For the Control group, examiner assessed metacarpophalangeal (MCP) 1-5, proximal interphalangeal (PIP) 1-5, wrists, elbows, shoulders, ankles, forefeet
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
Tender joint count
For the Control group, examiner assessed MCP 1-5, PIP 1-5, wrists, elbows, shoulders, ankles, forefeet
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
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.
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.
Costs related to hospital visits
Self-reported way of transport to the hospital; walking or bicycling/private car/public transportation/taxi/airplane/other.
Costs related to hospital visits
Self-reported travel distance in kilometres to the hospital.
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.
Health care utilization
Self-reported health care use and national register data on consultations and treatment in secondary and primary health care
Extra visits, telephone and video consultations
Number of extra visits to the hospital or video consultations with a health care provider
Withdrawals/Early discontinuation
Number of withdrawals/early discontinuation
Adverse events
Number of adverse events, serious adverse events, and withdrawals because of adverse events.
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.
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.
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)
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.
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.
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.

Full Information

First Posted
August 23, 2021
Last Updated
March 5, 2023
Sponsor
Diakonhjemmet Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05031767
Brief Title
Remote Monitoring of Axial Spondyloarthritis
Acronym
ReMonit
Official Title
Remote Monitoring of Axial Spondyloarthritis in Specialist Healthcare Services
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 7, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diakonhjemmet Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
The trial will include Norwegian adult males and females with axial spondyloarthritis. 240 participants will be randomized 1:1:1 to either: 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 Remote monitoring: hospital health professionals (HPs) perform remote monitoring of frequent PROs, blood test results, and physical activity data available on a digital platform 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axial Spondyloarthritis
Keywords
rheumatic diseases, musculoskeletal diseases, joint diseases, arthritis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
243 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Conventional current follow-up strategy
Arm Title
Remote monitoring
Arm Type
Experimental
Arm Description
Remote monitoring by health professionals at the hospital
Arm Title
Patient-initiated care
Arm Type
Experimental
Arm Description
No pre-scheduled visits or remote monitoring.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Remote monitoring
Intervention Description
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 .
Intervention Type
Other
Intervention Name(s)
Patient-initiated care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Low disease activity at follow-up
Description
The proportion of patients with low disease activity (defined as ASDAS <2.1) at the 6-months follow-up
Time Frame
6 months
Title
Low disease activity at follow-up
Description
The proportion of patients with low disease activity (defined as ASDAS <2.1) at the 12- months follow-up
Time Frame
12 months
Title
Low disease activity at follow-up
Description
The proportion of patients with low disease activity (defined as ASDAS <2.1) at the 18-months follow-up
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Description
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.
Time Frame
Baseline, 6, 12 and 18 months
Title
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Description
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.
Time Frame
Every month, maximum 18 months
Title
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Description
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.
Time Frame
Baseline, 6, 12 and 18 months
Title
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Description
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.
Time Frame
Every month, maximum 18 months
Title
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Description
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.
Time Frame
Baseline, 3, 6, 9, 12, 15 and 18 months
Title
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Description
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.
Time Frame
Every month, maximum 18 months
Title
C-Reactive Protein (CRP)
Description
CRP measured at home in a subgroup among the Remote monitoring group
Time Frame
Every month, maximum 18 months
Title
Patient global assessment of disease activity
Description
Patient-reported disease activity last 7 days on a NRS 0-10 ; higher value indicate worse outcome
Time Frame
Baseline, 6, 12 and 18 months
Title
Patient global assessment of disease activity
Description
Monthly reported by the Remote monitoring group. Patient-reported disease activity last 7 days on a NRS 0-10 ; higher value indicate worse outcome
Time Frame
Every month, maximum 18 months
Title
Patient global assessment of disease activity
Description
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
Time Frame
3, 6, 9, 12, 15 and 18 months
Title
Patient-reported flare
Description
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.
Time Frame
6, 12 and 18 months
Title
Patient-reported flare
Description
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.
Time Frame
Every month, maximum 18 months
Title
Patient-reported flare
Description
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.
Time Frame
3, 6, 9, 12, 15 and 18 months
Title
Bath Ankylosing Spondylitis Functional Index (BASFI)
Description
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.
Time Frame
Baseline, 6, 12 and 18 months
Title
Activity Impairment
Description
Item no.6 from Work Productivity and Activity Impairment (WPAI): self-reported activity impairment on a NRS 0-10; higher value indicate worse outcome.
Time Frame
Baseline, 6, 12 and 18 months
Title
Patient-reported global change in disease activity
Description
Single item with seven-point response scale ranging from "Much worse" to "Much better".
Time Frame
6, 12 and 18 months
Title
Patient-reported global change in activity impairment
Description
Single item with seven-point response scale ranging from "Much worse" to "Much better".
Time Frame
6, 12 and 18 months
Title
Pain (general)
Description
Self-reported pain level last 7 days hours on a NRS 0-10; higher value indicate worse outcome.
Time Frame
Baseline, 6, 12 and 18 months
Title
Joint pain
Description
Self-reported joint pain level last 7 days hours on a NRS 0-10; higher value indicate worse outcome.
Time Frame
Baseline, 6, 12 and 18 months
Title
Sleep impairment
Description
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.
Time Frame
Baseline, 6, 12 and 18 months
Title
Patient satisfaction with care
Description
1 item with five point response options ranging from "Very satisfied" to "Very dissatisfied", higher value indicate better outcome
Time Frame
Baseline, 6, 12 and 18 months
Title
Daily steps
Description
Remote monitoring and Patient-initiated care groups, number of steps during daytime captured by wearing a smartwatch
Time Frame
Through study completion, maximum 18 months
Title
Mean pulse level
Description
Remote monitoring and Patient-initiated care groups, mean pulse level during daytime captured by wearing a smartwatch
Time Frame
Through study completion, maximum 18 months
Title
Euro Quality of Life 5 Dimensions 5 Levels (EQ5D-5L)
Description
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
Time Frame
Baseline, 6, 12 and 18 months
Title
Concomitant medication
Description
Self-reported use of NSAIDs and analgesics and national register data from The Norwegian Prescription Register
Time Frame
Baseline, 6, 12 and 18 months
Title
Swollen joint count
Description
For the Control group, examiner assessed metacarpophalangeal (MCP) 1-5, proximal interphalangeal (PIP) 1-5, wrists, elbows, shoulders, ankles, forefeet
Time Frame
Baseline, 6, 12 and 18 months
Title
Swollen joint count
Description
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
Time Frame
Baseline, through study completion, and 18 months
Title
Tender joint count
Description
For the Control group, examiner assessed MCP 1-5, PIP 1-5, wrists, elbows, shoulders, ankles, forefeet
Time Frame
Baseline, 6, 12 and 18 months
Title
Tender joint count
Description
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
Time Frame
Baseline, through study completion, and 18 months
Title
Heel enthesitis
Description
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.
Time Frame
Baseline, 6, 12 and 18 months
Title
Heel enthesitis
Description
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.
Time Frame
Baseline, through study completion, and 18 months
Title
Costs related to hospital visits
Description
Self-reported way of transport to the hospital; walking or bicycling/private car/public transportation/taxi/airplane/other.
Time Frame
Baseline
Title
Costs related to hospital visits
Description
Self-reported travel distance in kilometres to the hospital.
Time Frame
Baseline
Title
The need to take time off work for hospital visits or video consultations
Description
If in paid work, the need to take time off from work is indicated as yes or no.
Time Frame
Baseline
Title
Health care utilization
Description
Self-reported health care use and national register data on consultations and treatment in secondary and primary health care
Time Frame
Baseline, 6, 12 and 18 months
Title
Extra visits, telephone and video consultations
Description
Number of extra visits to the hospital or video consultations with a health care provider
Time Frame
Through study completion, maximum 18 months
Title
Withdrawals/Early discontinuation
Description
Number of withdrawals/early discontinuation
Time Frame
Through study completion, maximum 18 months
Title
Adverse events
Description
Number of adverse events, serious adverse events, and withdrawals because of adverse events.
Time Frame
Through study completion, maximum 18 months
Title
Patient-reported self-efficacy for using different digital devices, secure login and digital health services measured on a Likert scale
Description
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.
Time Frame
Baseline
Title
eHealth literacy
Description
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.
Time Frame
Baseline
Title
Body signs and symptoms
Description
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)
Time Frame
18 months
Title
Patient satisfaction with remote monitoring or patient-initiated care
Description
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.
Time Frame
18 months
Title
Patient satisfaction with remote monitoring or patient-initiated care
Description
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.
Time Frame
18 months
Title
Preferred follow-up strategy
Description
One item on whether the preferred follow-up strategy would be Remote monitoring or Patient-initated care reported by the two intervention groups only.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tore Kvien, MD, Professor em
Organizational Affiliation
Diakonhjemmet Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Diakonhjemmet Hospital
City
Oslo
ZIP/Postal Code
0319
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

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Remote Monitoring of Axial Spondyloarthritis

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