Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT03977051
Status:
COMPLETED
Last Update Posted:
2024-04-12
First Post:
2017-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Exploring Immunosuppressant Medication Adherence in Kidney Transplant Patients
Sponsor:
Organization:
Raw JSON
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What importance do patients attach to adherence. Do patients understand that nonadherence may effect the outcome of the transplant. The focus groups will identify the common practical and perceptual barriers to adherence identified by transplant patients and the interventions kidney transplant patients have used to try and improve their adherence. The focus groups will identify which interventions patients have found effective and which interventions patients have not found to be effective to improve their adherence. 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What importance do patients attach to adherence. Do patients understand that nonadherence may effect the outcome of the transplant. The focus groups will identify the common practical and perceptual barriers to adherence identified by transplant patients and the interventions kidney transplant patients have used to try and improve their adherence. The focus groups will identify which interventions patients have found effective and which interventions patients have not found to be effective to improve their adherence. They will also identify support patients have had with adherence since their transplant, the support patients feel could have helped them to better adhere to their medicines up to now and the support our patients feel would help them to adhere better to their medicines in the future", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Focus Group', 'description': 'Focus group to explore immunosuppressant medication adherence in kidney transplant patients\n\nFocus group: Kidneys transplant patients will discuss their attitudes and beliefs towards immunosuppressant medication adherence'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Focus Group', 'description': 'Focus group to explore immunosuppressant medication adherence in kidney transplant patients\n\nFocus group: Kidneys transplant patients will discuss their attitudes and beliefs towards immunosuppressant medication adherence'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.19', 'groupId': 'BG000', 'lowerLimit': '26.53', 'upperLimit': '72.33'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Years since transplant', 'classes': [{'categories': [{'measurements': [{'value': '4.35', 'groupId': 'BG000', 'lowerLimit': '0.19', 'upperLimit': '13.99'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-23', 'size': 429087, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-10-18T10:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-25', 'studyFirstSubmitDate': '2017-04-25', 'resultsFirstSubmitDate': '2019-10-18', 'studyFirstSubmitQcDate': '2019-06-04', 'lastUpdatePostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-25', 'studyFirstPostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Kidney Transplant Patients Who Expressed an Understanding of the Term Immunosuppression Medication Adherence and the Importance Immunosuppression Medication Adherence Post Transplant', 'timeFrame': '4 months', 'description': "Through a series of focus groups, the investigators will qualitatively explore kidney transplant patients' understanding of the terms immunosuppressant medication adherence and nonadherence. What importance do patients attach to adherence. Do patients understand that nonadherence may effect the outcome of the transplant. The focus groups will identify the common practical and perceptual barriers to adherence identified by transplant patients and the interventions kidney transplant patients have used to try and improve their adherence. The focus groups will identify which interventions patients have found effective and which interventions patients have not found to be effective to improve their adherence. They will also identify support patients have had with adherence since their transplant, the support patients feel could have helped them to better adhere to their medicines up to now and the support our patients feel would help them to adhere better to their medicines in the future"}, {'measure': 'Number of Kidney Transplant Patients Who Identified Interventions to Support Immunosuppressant Medication Adherence', 'timeFrame': '4 months', 'description': "Through a series of focus groups, the investigators will qualitatively explore kidney transplant patients' understanding of the terms immunosuppressant medication adherence and nonadherence. What importance do patients attach to adherence. Do patients understand that nonadherence may effect the outcome of the transplant. The focus groups will identify the common practical and perceptual barriers to adherence identified by transplant patients and the interventions kidney transplant patients have used to try and improve their adherence. The focus groups will identify which interventions patients have found effective and which interventions patients have not found to be effective to improve their adherence. They will also identify support patients have had with adherence since their transplant, the support patients feel could have helped them to better adhere to their medicines up to now and the support our patients feel would help them to adhere better to their medicines in the future"}, {'measure': 'Number of Patients Who Identify Barriers to Immunosuppression Medication Adherence', 'timeFrame': '4 months', 'description': "Through a series of focus groups, the investigators will qualitatively explore kidney transplant patients' understanding of the terms immunosuppressant medication adherence and nonadherence. What importance do patients attach to adherence. Do patients understand that nonadherence may effect the outcome of the transplant. The focus groups will identify the common practical and perceptual barriers to adherence identified by transplant patients and the interventions kidney transplant patients have used to try and improve their adherence. The focus groups will identify which interventions patients have found effective and which interventions patients have not found to be effective to improve their adherence. They will also identify support patients have had with adherence since their transplant, the support patients feel could have helped them to better adhere to their medicines up to now and the support our patients feel would help them to adhere better to their medicines in the future"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kidney transplantation'], 'conditions': ['Adherence, Medication', 'Transplantation, Kidney']}, 'descriptionModule': {'briefSummary': 'To describe the beliefs, understanding and experience of immunosuppressant medication adherence in our current transplant patient population through a series of patient focus groups', 'detailedDescription': 'The investigators want to understand more about why some of our kidney transplant patients find it difficult to take their anti-rejection medicines as intended. It is hoped that if the investigators can improve their understanding of why some patients struggle with their anti-rejection medicines, the investigators will be able to find better ways to help our transplant patients and so fewer patients may develop problems with their transplant. This study will collect qualitative data from a series of focus groups with kidney transplant recipients to explore their beliefs, understanding and experience of anti-rejection medication adherence. The focus groups will also explore the support that participants have received to help them with their medication adherence and what support they feel should be available to them and to others in the future to optimise anti-rejection medication adherence in transplant patients. Five focus groups will be undertaken. Each focus group will include six patients and will last for approximately 1.5 hours. All participants will be kidney transplant recipients transplanted and followed up at Imperial College Renal and Transplant Centre.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Kidney transplant patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Kidney transplant recipients transplanted and under the active follow up of ICRTC.\n* Speak and understand English\n* 18 years and above\n\nExclusion Criteria:\n\n* Unable to speak and understand English\n* Below 18 years'}, 'identificationModule': {'nctId': 'NCT03977051', 'briefTitle': 'Exploring Immunosuppressant Medication Adherence in Kidney Transplant Patients', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Exploring Immunosuppressant Medication Adherence in Kidney Transplant Patients', 'orgStudyIdInfo': {'id': '16HH3697'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Focus group', 'description': 'Focus group to explore immunosuppressant medication adherence in kidney transplant patients', 'interventionNames': ['Behavioral: Focus group']}], 'interventions': [{'name': 'Focus group', 'type': 'BEHAVIORAL', 'description': 'Kidneys transplant patients will discuss their attitudes and beliefs towards immunosuppressant medication adherence', 'armGroupLabels': ['Focus group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W12 0HS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College Renal and Transplant Centre', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Dawn Goodall, MSC, BSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College Healthcare NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}