Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT04623151
Status:
COMPLETED
Last Update Posted:
2020-11-10
First Post:
2017-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Manipulating Narrative Presentations of Information to Encourage Good Foot Care Practice in People With and Without Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D005534', 'term': 'Foot Diseases'}, {'id': 'D033262', 'term': 'Narration'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1. Online leaflet about foot care in a narrative format\n2. Online leaflet about foot care in a non-narrative format\n3. No leaflet (control)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 452}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-09', 'studyFirstSubmitDate': '2017-10-16', 'studyFirstSubmitQcDate': '2020-11-09', 'lastUpdatePostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '5-item Foot Care Detection Behaviour Scale', 'timeFrame': '1 week', 'description': 'Questionnaire asking participants how many days in the past 7 they have checked their feet to detect cuts, blisters, sores, calluses, and red patches'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Foot care', 'narrative', 'diabetes', 'health behaviour', 'health psychology'], 'conditions': ['Diabetic Foot', 'Health Behavior', 'Foot Diseases']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://chichpscyh.eu.qualtrics.com/jfe/form/SV_eCF14PjJGVN0nGt', 'label': 'Online survey'}]}, 'descriptionModule': {'briefSummary': 'The study explores the role of health messages (narrative, non-narrative vs. control condition \\[no message\\]) to enhance good foot care practices among people with diabetes and the general population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 18 years of age at the time of consent;\n* able to read and speak the English language;\n* able and willing to give written informed consent prior to study entry;\n* able to complete the protocol requirements\n\nExclusion Criteria:\n\n* has a cognitive impairment or acute psychopathology (self-reported formal diagnoses of down syndrome, traumatic brain injury, brain tumour, autism, dementia, schizophrenia, and/or schizoaffective disorder), ie that which could interfere with his or her ability to provide written consent and complete the study\n* has taken part in any other research on foot care with the University of Chichester in the past year'}, 'identificationModule': {'nctId': 'NCT04623151', 'briefTitle': 'Manipulating Narrative Presentations of Information to Encourage Good Foot Care Practice in People With and Without Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'University of Chichester'}, 'officialTitle': 'Manipulating Narrative Presentations of Information to Encourage Good Foot Care Practice in People With and Without Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'UOCMRPHDS3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Online leaflet in narrative format', 'interventionNames': ['Behavioral: Online leaflet about foot care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Online leaflet in non-narrative format', 'interventionNames': ['Behavioral: Online leaflet about foot care']}, {'type': 'NO_INTERVENTION', 'label': 'No leaflet (control)'}], 'interventions': [{'name': 'Online leaflet about foot care', 'type': 'BEHAVIORAL', 'description': 'Short text-based leaflet about foot care, presented online', 'armGroupLabels': ['Online leaflet in narrative format', 'Online leaflet in non-narrative format']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PO19 6PE', 'city': 'Chichester', 'state': 'West Sussex', 'country': 'United Kingdom', 'facility': 'University of Chichester', 'geoPoint': {'lat': 50.83673, 'lon': -0.78003}}], 'overallOfficials': [{'name': 'Susan Churchill, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Chichester'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared outside of the study team'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chichester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}