Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT06056518
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-20
First Post:
2023-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigating the Impact of AI on Shared Decision Making in Post-kidney Transplant Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-17', 'studyFirstSubmitDate': '2023-09-21', 'studyFirstSubmitQcDate': '2023-09-21', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Qualitative analysis of semistructured interviews', 'timeFrame': '24 months', 'description': 'Qualitative analysis of semistructured interviews after 24 months'}, {'measure': 'Qualitative analysis of physician-patient conversations', 'timeFrame': '24 months', 'description': 'Qualitative analysis of physician-patient conversations after 24 months'}], 'primaryOutcomes': [{'measure': 'Conversation about kidney replacement therapy after graft loss', 'timeFrame': '12 months', 'description': 'Proportion of patients, with whom the necessity of kidney replacement therapy after kidney allograft loss is discussed'}], 'secondaryOutcomes': [{'measure': 'CollaboRATE mean score after 12 months', 'timeFrame': '12 months', 'description': 'CollaboRATE mean score of all study visits from study inclusion until month 12 (values 0 - 9, higher values indicating better outcome)'}, {'measure': 'CollaboRATE mean score after 24 months', 'timeFrame': '24 months', 'description': 'CollaboRATE mean score of all study visits from study inclusion until month 24 (values 0 - 9, higher values indicating better outcome)'}, {'measure': 'Control Preferences Scale mean after 12 months', 'timeFrame': '12 months', 'description': 'Mean Control Preferences Scale of all study visits from study inclusion until month 12 (values 1 - 5, higher values indicating better outcome)'}, {'measure': 'Control Preferences Scale mean after 24 months', 'timeFrame': '24 months', 'description': 'Mean Control Preferences Scale of all study visits from study inclusion until month 24 (values 1 - 5, higher values indicating better outcome)'}, {'measure': 'Kidney replacement therapy 12 months', 'timeFrame': '12 months', 'description': 'Frequency of kidney replacement therapy after graft loss 12 months'}, {'measure': 'Kidney replacement therapy 24 months', 'timeFrame': '24 months', 'description': 'Frequency of kidney replacement therapy after graft loss 24 months'}, {'measure': 'Emergency dialysis 12 months', 'timeFrame': '12 months', 'description': 'Frequency of emergency dialysis after graft loss 12 months'}, {'measure': 'Emergency dialysis 24 months', 'timeFrame': '24 months', 'description': 'Frequency of emergency dialysis after graft loss 24 months'}, {'measure': 'Dialysis initiation via AV-shunt 12 months', 'timeFrame': '12 months', 'description': 'Frequency of dialysis initiation via AV-shunt after graft loss 12 months'}, {'measure': 'Dialysis initiation via AV-shunt 24 months', 'timeFrame': '24 months', 'description': 'Frequency of dialysis initiation via AV-shunt after graft loss 24 months'}, {'measure': 'Dialysis initiation via permanent catheter 12 months', 'timeFrame': '12 months', 'description': 'Frequency of dialysis initiation via permanent catheter after graft loss 12 months'}, {'measure': 'Dialysis initiation via permanent catheter 24 months', 'timeFrame': '24 months', 'description': 'Frequency of dialysis initiation via permanent catheter after graft loss 24 months'}, {'measure': 'Retransplantation 12 months', 'timeFrame': '12 months', 'description': 'Frequency of retransplantation after graft loss 12 months'}, {'measure': 'Retransplantation 24 months', 'timeFrame': '24 months', 'description': 'Frequency of retransplantation after graft loss 24 months'}, {'measure': 'Conversation about kidney replacement therapy after graft loss', 'timeFrame': '24 months', 'description': 'Proportion of patients, with whom the necessity of kidney replacement therapy after kidney allograft loss is discussed'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kidney Transplantation', 'Graft Loss', 'Kidney Transplant Failure', 'Riks Prediction System'], 'conditions': ['Kidney Transplant Failure']}, 'referencesModule': {'references': [{'pmid': '38557315', 'type': 'DERIVED', 'citation': 'Osmanodja B, Sassi Z, Eickmann S, Hansen CM, Roller R, Burchardt A, Samhammer D, Dabrock P, Moller S, Budde K, Herrmann A. Investigating the Impact of AI on Shared Decision-Making in Post-Kidney Transplant Care (PRIMA-AI): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Apr 1;13:e54857. doi: 10.2196/54857.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to analyze the effects of AI-based risk prediction for graft loss on the frequency of conversations about the treatment after graft loss, as well as the associated shared decision making process in post-kidney transplant care in a German kidney transplant center (KTC), as perceived by the patient, their support person and the clinician/physician. Second, it aims to explore changes in patient and support person recall at 12 and 24 months follow-up. Implementation barriers and enablers will also be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'All genders (male, female, and others) are eligible for this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written informed consent\n* patients with functioning kidney allograft\n* \\> 12 months after transplantation\n* eGFR \\< 30 ml/min/1.73m2 according to CKD-EPI 2021 formula\n* at least 18 years of age\n* ability to communicate in German\n* regular follow-up at kidney transplant center\n\nExclusion Criteria:\n\n* multi-organ transplantation\n* eGFR \\> 30 ml/min/1.73m2 according to CKD-EPI 2021 formula\n* \\<= 12 months after transplantation\n* less than 18 years of age\n* not able to communicate in German\n* no regular follow-up at kidney transplant center\n* enrollment in another interventional study less than 1 month before participation in this study'}, 'identificationModule': {'nctId': 'NCT06056518', 'acronym': 'PRIMA-AI', 'briefTitle': 'Investigating the Impact of AI on Shared Decision Making in Post-kidney Transplant Care', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Prospective, Randomized Controlled Trial to Investigate the Impact of AI on Shared Decision Making in Post-kidney Transplant Care', 'orgStudyIdInfo': {'id': 'CHA-PRIMA-AI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Routine Care', 'description': 'Patients in the "Routine Care" arm are will undergo regular follow-up at the kidney transplant center.'}, {'type': 'EXPERIMENTAL', 'label': 'AI-supported Care', 'description': 'Patients in the "AI-supported Care" arm will undergo regular follow-up at the kidney transplant center. Treating physicians will be provided an AI-based risk prediction tool that predict 1-year risk of graft loss for patients in this group based on routine parameters.', 'interventionNames': ['Other: AI-based risk prediction for kidney graft loss']}], 'interventions': [{'name': 'AI-based risk prediction for kidney graft loss', 'type': 'OTHER', 'description': 'Implementation of AI-based risk prediction tool for the 1-year risk of kidney graft loss.', 'armGroupLabels': ['AI-supported Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Klemens Budde, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Klemens Budde', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}