Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 2:52 PM
Study NCT ID:
NCT06647433
Status:
RECRUITING
Last Update Posted:
2025-07-10
First Post:
2024-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
What is the Perceived Role of Risk in DOC Healthcare.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003244', 'term': 'Consciousness Disorders'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-04', 'studyFirstSubmitDate': '2024-10-16', 'studyFirstSubmitQcDate': '2024-10-16', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Meaning based themes on what influences decision making in DOC', 'timeFrame': '2 years', 'description': 'Thematic analysis (TA) will consolidate and develop themes across all data sources (i.e., interview and VRE transcripts, field notes). The planned TA approach will borrow theory from reflexive thematic analysis (Braun \\& Clarke, 2022) and a critical realist TA approach which supports causal explanation development (Fryer, 2022). Causal research questions will be developed and refined throughout data collection and explored through TA.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Disorders of Consciousness', 'Decision making'], 'conditions': ['Disorders of Consciousness']}, 'descriptionModule': {'briefSummary': 'Critical ethnography exploring how decisions are made on behalf of people in disorder of consciousness (DOC).\n\nProspective longitudinal case study design including observation, field interview and video reflexive ethnography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'people in a doc', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People in a DOC:\n* Working diagnosis of being in a DOC.\n* Have an appropriate family member able to act as a consultee.\n* Over 18 years of age.\n\nFamily members and healthcare workers:\n\n* conversational English.\n* able to give consent.\n* over 18 years of age.\n* Involved in decision making on behalf of a person in a DOC\n\nExclusion Criteria:\n\nPerson in a Disorder of Consciousness\n\n* Not in a DOC, diagnosis uncertain, or appears to be emerging.\n* Clinically unstable or approaching the end of their life.'}, 'identificationModule': {'nctId': 'NCT06647433', 'briefTitle': 'What is the Perceived Role of Risk in DOC Healthcare.', 'organization': {'class': 'OTHER', 'fullName': 'University of Nottingham'}, 'officialTitle': 'What is the Perceived Role of Risk in the Healthcare Received by People in Disorders of Consciousness (DOC)?', 'orgStudyIdInfo': {'id': '24051'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Observation', 'type': 'OTHER', 'description': 'case study will be observed participants, methods will include observation, interview and video reflexive ethnography'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW15 3SW', 'city': 'London', 'state': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Clark', 'role': 'CONTACT', 'email': 'tclark@rhn.org.uk'}], 'facility': 'Royal Hospital for Neurodisability', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NG7 2HA', 'city': 'Nottingham', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Teresa Clark', 'role': 'CONTACT', 'email': 'teresa.clark@nottingham.ac.uk', 'phone': '+44 2087804500'}], 'facility': 'University of Nottingham', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'centralContacts': [{'name': 'Teresa Clark, PhD Candidate UON', 'role': 'CONTACT', 'email': 'teresa.clark@nottingham.ac.uk', 'phone': '800-555-5555'}, {'name': 'Alison Edgley', 'role': 'CONTACT', 'email': 'alison.edgley@nottingham.ac.uk', 'phone': '800-555-5555'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nottingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'Royal Hospital for Neuro-disability', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}