Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT05031767
Status:
COMPLETED
Last Update Posted:
2024-02-29
First Post:
2021-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Remote Monitoring of Axial Spondyloarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000098465', 'term': 'Remote Patient Monitoring'}], 'ancestors': [{'id': 'D017216', 'term': 'Telemedicine'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-01', 'size': 2076651, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-02-19T07:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 243}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-27', 'studyFirstSubmitDate': '2021-08-23', 'studyFirstSubmitQcDate': '2021-08-26', 'lastUpdatePostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Low disease activity at follow-up', 'timeFrame': '6 months', 'description': 'The proportion of patients with low disease activity (defined as ASDAS \\<2.1) at the 6-months follow-up'}, {'measure': 'Low disease activity at follow-up', 'timeFrame': '12 months', 'description': 'The proportion of patients with low disease activity (defined as ASDAS \\<2.1) at the 12- months follow-up'}, {'measure': 'Low disease activity at follow-up', 'timeFrame': '18 months', 'description': 'The proportion of patients with low disease activity (defined as ASDAS \\<2.1) at the 18-months follow-up'}], 'secondaryOutcomes': [{'measure': 'Ankylosing Spondylitis Disease Activity Score (ASDAS)', 'timeFrame': 'Baseline, 6, 12 and 18 months', '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.'}, {'measure': 'Ankylosing Spondylitis Disease Activity Score (ASDAS)', 'timeFrame': 'Every month, maximum 18 months', '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.'}, {'measure': 'Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)', 'timeFrame': 'Baseline, 6, 12 and 18 months', '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.'}, {'measure': 'Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)', 'timeFrame': 'Every month, maximum 18 months', '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.'}, {'measure': 'Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)', 'timeFrame': 'Baseline, 3, 6, 9, 12, 15 and 18 months', '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.'}, {'measure': 'Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)', 'timeFrame': 'Every month, maximum 18 months', '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.'}, {'measure': 'C-Reactive Protein (CRP)', 'timeFrame': 'Every month, maximum 18 months', 'description': 'CRP measured at home in a subgroup among the Remote monitoring group'}, {'measure': 'Patient global assessment of disease activity', 'timeFrame': 'Baseline, 6, 12 and 18 months', 'description': 'Patient-reported disease activity last 7 days on a NRS 0-10 ; higher value indicate worse outcome'}, {'measure': 'Patient global assessment of disease activity', 'timeFrame': 'Every month, maximum 18 months', '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'}, {'measure': 'Patient global assessment of disease activity', 'timeFrame': '3, 6, 9, 12, 15 and 18 months', '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'}, {'measure': 'Patient-reported flare', 'timeFrame': '6, 12 and 18 months', '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.'}, {'measure': 'Patient-reported flare', 'timeFrame': 'Every month, maximum 18 months', '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.'}, {'measure': 'Patient-reported flare', 'timeFrame': '3, 6, 9, 12, 15 and 18 months', '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.'}, {'measure': 'Bath Ankylosing Spondylitis Functional Index (BASFI)', 'timeFrame': 'Baseline, 6, 12 and 18 months', '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.'}, {'measure': 'Activity Impairment', 'timeFrame': 'Baseline, 6, 12 and 18 months', '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.'}, {'measure': 'Patient-reported global change in disease activity', 'timeFrame': '6, 12 and 18 months', 'description': 'Single item with seven-point response scale ranging from "Much worse" to "Much better".'}, {'measure': 'Patient-reported global change in activity impairment', 'timeFrame': '6, 12 and 18 months', 'description': 'Single item with seven-point response scale ranging from "Much worse" to "Much better".'}, {'measure': 'Pain (general)', 'timeFrame': 'Baseline, 6, 12 and 18 months', 'description': 'Self-reported pain level last 7 days hours on a NRS 0-10; higher value indicate worse outcome.'}, {'measure': 'Joint pain', 'timeFrame': 'Baseline, 6, 12 and 18 months', 'description': 'Self-reported joint pain level last 7 days hours on a NRS 0-10; higher value indicate worse outcome.'}, {'measure': 'Sleep impairment', 'timeFrame': 'Baseline, 6, 12 and 18 months', '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.'}, {'measure': 'Patient satisfaction with care', 'timeFrame': 'Baseline, 6, 12 and 18 months', 'description': '1 item with five point response options ranging from "Very satisfied" to "Very dissatisfied", higher value indicate better outcome'}, {'measure': 'Daily steps', 'timeFrame': 'Through study completion, maximum 18 months', 'description': 'Remote monitoring and Patient-initiated care groups, number of steps during daytime captured by wearing a smartwatch'}, {'measure': 'Mean pulse level', 'timeFrame': 'Through study completion, maximum 18 months', 'description': 'Remote monitoring and Patient-initiated care groups, mean pulse level during daytime captured by wearing a smartwatch'}, {'measure': 'Euro Quality of Life 5 Dimensions 5 Levels (EQ5D-5L)', 'timeFrame': 'Baseline, 6, 12 and 18 months', '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'}, {'measure': 'Concomitant medication', 'timeFrame': 'Baseline, 6, 12 and 18 months', 'description': 'Self-reported use of NSAIDs and analgesics and national register data from The Norwegian Prescription Register'}, {'measure': 'Swollen joint count', 'timeFrame': 'Baseline, 6, 12 and 18 months', 'description': 'For the Control group, examiner assessed metacarpophalangeal (MCP) 1-5, proximal interphalangeal (PIP) 1-5, wrists, elbows, shoulders, ankles, forefeet'}, {'measure': 'Swollen joint count', 'timeFrame': 'Baseline, through study completion, and 18 months', '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'}, {'measure': 'Tender joint count', 'timeFrame': 'Baseline, 6, 12 and 18 months', 'description': 'For the Control group, examiner assessed MCP 1-5, PIP 1-5, wrists, elbows, shoulders, ankles, forefeet'}, {'measure': 'Tender joint count', 'timeFrame': 'Baseline, through study completion, and 18 months', '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'}, {'measure': 'Heel enthesitis', 'timeFrame': 'Baseline, 6, 12 and 18 months', '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.'}, {'measure': 'Heel enthesitis', 'timeFrame': 'Baseline, through study completion, and 18 months', '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.'}, {'measure': 'Costs related to hospital visits', 'timeFrame': 'Baseline', 'description': 'Self-reported way of transport to the hospital; walking or bicycling/private car/public transportation/taxi/airplane/other.'}, {'measure': 'Costs related to hospital visits', 'timeFrame': 'Baseline', 'description': 'Self-reported travel distance in kilometres to the hospital.'}, {'measure': 'The need to take time off work for hospital visits or video consultations', 'timeFrame': 'Baseline', 'description': 'If in paid work, the need to take time off from work is indicated as yes or no.'}, {'measure': 'Health care utilization', 'timeFrame': 'Baseline, 6, 12 and 18 months', 'description': 'Self-reported health care use and national register data on consultations and treatment in secondary and primary health care'}, {'measure': 'Extra visits, telephone and video consultations', 'timeFrame': 'Through study completion, maximum 18 months', 'description': 'Number of extra visits to the hospital or video consultations with a health care provider'}, {'measure': 'Withdrawals/Early discontinuation', 'timeFrame': 'Through study completion, maximum 18 months', 'description': 'Number of withdrawals/early discontinuation'}, {'measure': 'Adverse events', 'timeFrame': 'Through study completion, maximum 18 months', 'description': 'Number of adverse events, serious adverse events, and withdrawals because of adverse events.'}, {'measure': 'Patient-reported self-efficacy for using different digital devices, secure login and digital health services measured on a Likert scale', 'timeFrame': 'Baseline', '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."}, {'measure': 'eHealth literacy', 'timeFrame': 'Baseline', '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.'}, {'measure': 'Body signs and symptoms', 'timeFrame': '18 months', '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)"}, {'measure': 'Patient satisfaction with remote monitoring or patient-initiated care', 'timeFrame': '18 months', '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.'}, {'measure': 'Patient satisfaction with remote monitoring or patient-initiated care', 'timeFrame': '18 months', '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.'}, {'measure': 'Preferred follow-up strategy', 'timeFrame': '18 months', '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rheumatic diseases', 'musculoskeletal diseases', 'joint diseases', 'arthritis'], 'conditions': ['Axial Spondyloarthritis']}, 'referencesModule': {'references': [{'pmid': '38150310', 'type': 'DERIVED', 'citation': 'Berg IJ, Tveter AT, Bakland G, Hakim S, Kristianslund EK, Lillegraven S, Macfarlane GJ, Moholt E, Provan SA, Sexton J, Thomassen EE, De Thurah A, Gossec L, Haavardsholm EA, Osteras N. Follow-Up of Patients With Axial Spondyloarthritis in Specialist Health Care With Remote Monitoring and Self-Monitoring Compared With Regular Face-to-Face Follow-Up Visits (the ReMonit Study): Protocol for a Randomized, Controlled Open-Label Noninferiority Trial. JMIR Res Protoc. 2023 Dec 27;12:e52872. doi: 10.2196/52872.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The trial will include Norwegian adult males and females with axial spondyloarthritis.\n\n240 participants will be randomized 1:1:1 to either:\n\n1. 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\n2. Remote monitoring: hospital health professionals (HPs) perform remote monitoring of frequent PROs, blood test results, and physical activity data available on a digital platform\n3. Patient-initiated care: no pre-scheduled visits or remote monitoring\n\nThe study has 18 months follow-up. We will use a 15% non-inferiority margin.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or non-pregnant, non-nursing female \\>18 years of age at screening\n* Patients with a diagnosis of axSpA who fulfil the diagnostic Assessment of SpondyloArthritis International Society (ASAS) criteria for axSpA\n* Stable medical treatment with TNFi the last 6 months\n* Low disease activity (ASDAS\\<2.1) at inclusion\n* Capable of understanding the Norwegian language and of signing an informed consent form\n\nExclusion Criteria:\n\nMedical conditions:\n\n* 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.\n* Indications of active tuberculosis (TB)\n\nDiagnostic assessments:\n\n* 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\n* Abnormal liver function (defined as Alanine Transaminase (ALT) \\>3x upper normal limit), active or recent hepatitis\n* Leukopenia and/or thrombocytopenia\n\nOther:\n\n* Pregnancy and/or breastfeeding (current at screening or planned within the duration of the study)\n* Severe psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible'}, 'identificationModule': {'nctId': 'NCT05031767', 'acronym': 'ReMonit', 'briefTitle': 'Remote Monitoring of Axial Spondyloarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Diakonhjemmet Hospital'}, 'officialTitle': 'Remote Monitoring of Axial Spondyloarthritis in Specialist Healthcare Services', 'orgStudyIdInfo': {'id': 'REK no.:229187'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'Conventional current follow-up strategy', 'interventionNames': ['Other: Usual care']}, {'type': 'EXPERIMENTAL', 'label': 'Remote monitoring', 'description': 'Remote monitoring by health professionals at the hospital', 'interventionNames': ['Other: Remote monitoring']}, {'type': 'EXPERIMENTAL', 'label': 'Patient-initiated care', 'description': 'No pre-scheduled visits or remote monitoring.', 'interventionNames': ['Other: Patient-initiated care']}], 'interventions': [{'name': 'Usual care', 'type': 'OTHER', 'description': 'Conventional follow-up strategy with blood tests, patient-reported outcomes, and pre-scheduled visits at the hospital every 6th month.\n\nContinue 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.', 'armGroupLabels': ['Usual care']}, {'name': 'Remote monitoring', 'type': 'OTHER', 'description': 'Hospital health professionals perform remote monitoring of frequent patient-reported outcomes, blood test results, and physical activity data available on a digital platform.\n\nContinue 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 .', 'armGroupLabels': ['Remote monitoring']}, {'name': 'Patient-initiated care', 'type': 'OTHER', 'description': 'No pre-scheduled visits or remote monitoring.\n\nContinue 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.', 'armGroupLabels': ['Patient-initiated care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0319', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Diakonhjemmet Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Tore Kvien, MD, Professor em', 'role': 'STUDY_CHAIR', 'affiliation': 'Diakonhjemmet Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diakonhjemmet Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Nina Osteras', 'investigatorAffiliation': 'Diakonhjemmet Hospital'}}}}