Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:50 PM
Study NCT ID:
NCT04327167
Status:
UNKNOWN
Last Update Posted:
2020-03-30
First Post:
2019-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Digital Intervention for Ethnic Groups in Transplantation (DIGIT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014743', 'term': 'Videotape Recording'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D013637', 'term': 'Tape Recording'}, {'id': 'D001296', 'term': 'Audiovisual Aids'}, {'id': 'D018961', 'term': 'Educational Technology'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D013690', 'term': 'Television'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-27', 'studyFirstSubmitDate': '2019-12-03', 'studyFirstSubmitQcDate': '2020-03-27', 'lastUpdatePostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Magnitude of the change in score assessing knowledge of LDKT by study questionnaire', 'timeFrame': '2 years', 'description': 'Change in attitudes and knowledge of LDKT will be assessed by study questionnaire and the magnitude in change will be quantified by the change in score following digital intervention'}], 'secondaryOutcomes': [{'measure': 'Magnitude of change in QOL score pre donation to 1 year post donation', 'timeFrame': '2 years', 'description': 'Change in QOL as measured by SF 36 in the 3 months preceding donation and 1 year post donation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Live Donors, Ethnic Minorities, Transplantation']}, 'referencesModule': {'references': [{'pmid': '38040423', 'type': 'DERIVED', 'citation': 'Brand S, Daga S, Mistry K, Morsy M, Bagul A, Hamer R, Malik S. Sikh and Muslim perspectives on kidney transplantation: phase 1 of the DiGiT project - a qualitative descriptive study. BMJ Open. 2023 Dec 1;13(12):e059668. doi: 10.1136/bmjopen-2021-059668.'}]}, 'descriptionModule': {'briefSummary': 'Study Title Digital intervention for Ethnic Groups in Transplantation (DiGiT)\n\nInternal ref. no. (or short title) DiGiT Study Design Observational cohort study Study Participants 90 Planned Size of Sample (if applicable) 30 Follow up duration (if applicable) 2 years Planned Study Period 2 years Research Question/Aim(s)\n\n1. To produce, test and pilot a video-based intervention about living donor kidney transplantation in Black, Asian \\& Minority ethnic (BAME) community in United Kingdom. Embedded within this is an ambassador training.\n2. Study the long term psychological impact of BAME donors following donation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults \\>18 years of age\n* Belong to a BAME community only for phase 1-3, in phase 4 all past and future donors regardless of ethnicity would be eligible.\n* Be a community member, past donor, past recipient of a transplant, healthcare professional or be on the waiting list for a transplant.\n\nExclusion Criteria:\n\n* Anyone less than 18 years of age\n* Unable to consent'}, 'identificationModule': {'nctId': 'NCT04327167', 'acronym': 'DiGiT', 'briefTitle': 'Digital Intervention for Ethnic Groups in Transplantation (DIGIT)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Coventry and Warwickshire NHS Trust'}, 'officialTitle': 'Digital Intervention for Ethnic Groups in Transplantation (DIGIT)', 'orgStudyIdInfo': {'id': 'IRAS 250798'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Digital intervention', 'interventionNames': ['Behavioral: Video and questionnaire']}], 'interventions': [{'name': 'Video and questionnaire', 'type': 'BEHAVIORAL', 'otherNames': ['Digital intervention'], 'description': 'Potential donors would be shown a video and asked to complete a questionnaire to capture change in attitude towards donation.', 'armGroupLabels': ['Digital intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Coventry', 'state': 'West Midlands', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Shafi Malik', 'role': 'CONTACT', 'email': 'shafi.malik1@nhs.net', 'phone': '024 7696 4000'}], 'facility': 'Shafi Malik', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Coventry and Warwickshire NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}