Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-28 @ 9:26 PM
Study NCT ID:
NCT04771260
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2021-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Understanding Health Services Delivery for Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-15', 'size': 382093, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-02-18T11:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-19', 'studyFirstSubmitDate': '2021-02-22', 'studyFirstSubmitQcDate': '2021-02-22', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Model of care', 'timeFrame': 'By February 2022', 'description': 'For each case study, how health and social care is being delivered will be the main outcome.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fibromyalgia', 'Fibromyalgia, Primary', 'Fibromyalgia, Secondary']}, 'descriptionModule': {'briefSummary': 'This research study aims to:\n\ni) Explore and understand how health and social care for people with fibromyalgia living in the UK is organised and delivered.\n\nii) Identify models of practice to inform co-design of new care pathways for people with fibromyalgia living in the UK.\n\nTo do this, up to ten UK-based case studies will be conducted in total: at least one each in England, Scotland and Wales. Interviews will be conducted with approximately 10 participants per case study, for a total of 100 participant interviews. Qualitative observations (in-person or on-line) will be conducted with a similar number of people (total 100 participants). Online focus groups will also be carried out with approximately 6 to 8 participants per group (up to ten groups for a total 60-80 participants). Participants will include healthcare professionals (for example, doctors, nurses, allied health professionals), social care practitioners (for example, social prescribers), service delivery managers, commissioners and other individuals involved in the organisation and delivery of health and social care services for people with fibromyalgia living in the UK.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will include healthcare professionals (for example, doctors, nurses, allied health professionals), social care practitioners (for example, social prescribers), service delivery managers, commissioners and other individuals involved in the organisation and delivery of health and social care services for people with fibromyalgia living in the UK.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* NHS and/or non-NHS organisations in the UK providing health and social care to people with fibromyalgia.\n* Health and social care professionals identifying and or providing support for people with fibromyalgia in one of the ten case studies.\n* NHS/non-NHS staff influential in the organisation and/or delivery of health and social care to people with fibromyalgia in one of the ten case studies, for example, service managers, professional service leads, commissioners.\n\nExclusion Criteria:\n\n* NHS/non-NHS organisations in the UK not providing health or social care to people with fibromyalgia.\n* NHS/non-NHS staff who are not able to communicate sufficiently well in English to participate effectively.'}, 'identificationModule': {'nctId': 'NCT04771260', 'briefTitle': 'Understanding Health Services Delivery for Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'University of Aberdeen'}, 'officialTitle': 'A Realist-informed Investigation of the Organisation and Delivery of Health and Social Care Services for People With Fibromyalgia Living in the UK', 'orgStudyIdInfo': {'id': '02/068/20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case study #1', 'description': 'There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care.'}, {'label': 'Case study #2', 'description': 'There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care.'}, {'label': 'Case study #3', 'description': 'There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care.'}, {'label': 'Case study #4', 'description': 'There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care.'}, {'label': 'Case study #5', 'description': 'There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care.'}, {'label': 'Case study #6', 'description': 'There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care.'}, {'label': 'Case study #7', 'description': 'There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care.'}, {'label': 'Case study #8', 'description': 'There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care.'}, {'label': 'Case study #9', 'description': 'There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care.'}, {'label': 'Case study #10', 'description': 'There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aberdeen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}