Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
Study NCT ID:
NCT06461000
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2024-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EULAR Impact of Rheumatic and Musculoskeletal Diseases Survey
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-06-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2024-06-04', 'studyFirstSubmitQcDate': '2024-06-10', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'General population description - country', 'timeFrame': 'every 6 months for up to 5 years', 'description': 'country of residence'}, {'measure': 'General population description - diagnosis', 'timeFrame': 'every 6 months for up to 5 years', 'description': 'diagnosis (name of the disease)'}, {'measure': 'General population description', 'timeFrame': 'every 6 months for up to 5 years', 'description': 'year of birth'}], 'secondaryOutcomes': [{'measure': 'Diagnosis history - physician treating the RMD', 'timeFrame': 'every 6 months for up to 5 years', 'description': 'Primary physician specialty treating the patient'}, {'measure': 'Diagnosis history - outpatient care history', 'timeFrame': 'every 6 months for up to 5 years', 'description': 'number of medical appointments for the past 6 months'}, {'measure': 'Diagnosis history - timeline', 'timeFrame': 'every 6 months for up to 5 years', 'description': 'waiting time for medical appointments and time spent in medical appointments'}, {'measure': 'Diagnosis history - Inpatient care', 'timeFrame': 'every 6 months for up to 5 years', 'description': 'number of days of hospitalization during the past 6 months.'}, {'measure': 'Non-pharmacological and pharmacological treatments.', 'timeFrame': 'every 6 months for up to 5 years', 'description': 'Names of medications taken by the patients (from a list)'}, {'measure': 'Other chronic diseases', 'timeFrame': 'every 6 months for up to 5 years', 'description': 'diagnosis of chronic diseases other than RMD and medication taken for these conditions.'}, {'measure': 'Disease burden - impact of disease', 'timeFrame': 'every 6 months for up to 5 years', 'description': 'Rheumatic Arthritis Impact of Disease (RAID) version 7 questionnaire. The RAID is calculated based on 7 Numerical rating scales (NRS) questions. Each NRS is assessed as a number between 0 and 10. The 7 NRS correspond to pain, function, fatigue, sleep, emotional well-being, physical well-being, and coping/self-efficacy. The range of the final RAID value is 0-10 where higher figures indicate worse status.'}, {'measure': 'Disease burden - health assessment', 'timeFrame': 'every 6 months for up to 5 years', 'description': 'Health assessment questionnaire version 2 (HAQ2). The HAQ comprises of 20 questions covering 20 daily activities. These are divided in eight domains: dressing and grooming, rising, eating, walking, hygiene, reaching, gripping, and other activities. Each question is scored according to a four-point scale (0-3), and the highest scores from each domain are summed and divided by eight, to derive a total HAQ score, which ranges from 0 to 3 (3 = highest level of disability).'}, {'measure': 'Disease burden - quality of life', 'timeFrame': 'every 6 months for up to 5 years', 'description': 'patient health questionnaire (PHQ-8). The PHQ-8 is a self-reported measure of depressive symptoms composed of 8 Likert type items with a response scale ranging from 0 (Not at all) to 3 (Nearly every day), that refer to the presence of that symptom during the previous 2 weeks.Each item corresponds to the first 8 symptoms of the 4th edition of the DSM-IV diagnostic criteria for major depressive disorder. The PHQ-8 final score is obtained by adding the score for each of the items, ranging from 0 to 24 (higher scores corresponding to higher levels of depression).'}, {'measure': 'Consequences on work and life (WPAI questionnaire)', 'timeFrame': 'every 6 months for up to 5 years', 'description': 'work productivity and activity impairment questionnaire (WPAI), including total number of sick leave days due to RMD in the past 6 months. Final score is calculated in % higher scores on the WPAI indicate worse outcomes'}, {'measure': 'Other barriers due to RMD', 'timeFrame': 'every 6 months for up to 5 years', 'description': 'impact on family, leisure, social and work activities (quality of life questionnaire)'}, {'measure': 'Health care', 'timeFrame': 'every 6 months for up to 5 years', 'description': 'support from professionals (general questionnaire), satisfaction with care (scale, 1= low, 5 = high satisfaction)'}, {'measure': 'Demographics - persons living with patient', 'timeFrame': 'every 6 months for up to 5 years', 'description': 'number of persons living in household'}, {'measure': 'Demographics - professional status', 'timeFrame': 'every 6 months for up to 5 years', 'description': 'professional status'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatologic Disease', 'Musculoskeletal Diseases']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.eular.org/eular-impact-of-rmds-survey', 'label': 'EULAR Impact of RMDs Survey'}]}, 'descriptionModule': {'briefSummary': 'The EULAR Impact of RMDs Survey collects first-hand information about the impact of rheumatic and musculoskeletal diseases (RMDs) among patients across and beyond Europe. Through periodic questionnaires, patients will provide information about their healthcare situation, and how the disease affects their social and occupational lives. This data will be an important resource for researchers, healthcare professionals, and patients alike, providing valuable insights into the burden of disease and helping improve the overall care for people living with these conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '\\- adults with at least 1 RMD', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-year-old at time of baseline survey\n* Living in a EULAR country at time of baseline survey\n* Diagnosed with at least one RMD\n* Valid personal e-mail address\n* Being able to use an internet website\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT06461000', 'acronym': 'ImpactSurvey', 'briefTitle': 'EULAR Impact of Rheumatic and Musculoskeletal Diseases Survey', 'organization': {'class': 'OTHER', 'fullName': 'European Alliance of Associations in Rheumatology'}, 'officialTitle': 'EULAR Impact of Rheumatic and Musculoskeletal Diseases Survey', 'orgStudyIdInfo': {'id': 'EPI001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Survey', 'description': 'Usual survey', 'interventionNames': ['Other: Survey']}], 'interventions': [{'name': 'Survey', 'type': 'OTHER', 'description': 'online survey for participants', 'armGroupLabels': ['Survey']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8802', 'city': 'Kilchberg', 'state': 'Canton of Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Coralie Signorell, PhD', 'role': 'CONTACT', 'email': 'research@eular.org', 'phone': '+41 44 575 15 64'}], 'facility': 'EULAR', 'geoPoint': {'lat': 47.32438, 'lon': 8.54548}}], 'centralContacts': [{'name': 'Coralie Signorell, PhD', 'role': 'CONTACT', 'email': 'coralie.signorell@eular.org', 'phone': '0445751564'}, {'name': 'Carina Haupt', 'role': 'CONTACT', 'email': 'carina.haupt@eular.org', 'phone': '+41 44 716 30 46'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Alliance of Associations in Rheumatology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}