Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT05879302
Status:
RECRUITING
Last Update Posted:
2024-11-15
First Post:
2023-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Shared Decision Making for Kidney Transplant Candidates to Plan for an Organ Offer Decision
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'All study personnel involved in screening and enrollment will be masked to upcoming randomization assignments'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2023-05-17', 'studyFirstSubmitQcDate': '2023-05-25', 'lastUpdatePostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Willingness to accept donor organs at risk of discard', 'timeFrame': 'Up to 2 months', 'description': 'Willingness to accept a donor kidney offer will be measured by three items on a 5-point Likert scale anchored by "strongly agree" and "strongly disagree." Willingness to accept will be defined by answers of "agree" or "strongly agree."'}], 'secondaryOutcomes': [{'measure': 'Knowledge', 'timeFrame': 'Up to 2 months', 'description': '10 Knowledge questions relating to organ offers and organ quality'}, {'measure': 'Decisional Conflict', 'timeFrame': 'Up to 2 months', 'description': '16 Decisional Conflict questions (Ottawa scale)'}, {'measure': 'Distress', 'timeFrame': 'Up to 2 months', 'description': '5 STOP-D (Screening Tool for Psychological Distress) questions'}, {'measure': 'Shared Decision Making', 'timeFrame': 'Up to 2 months', 'description': '9 items of the SDMQ9 for Shared Decision Making'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Shared Decision Making', 'SDM', 'Transplantation', 'Organ offer', 'Kidney offer', 'KDPI'], 'conditions': ['End Stage Renal Disease', 'End-Stage Kidney Disease', 'Kidney Transplantation', 'Esrd']}, 'descriptionModule': {'briefSummary': 'The goal of this pilot randomized trial is to learn about shared decision making in kidney transplant candidates. The aim of this proposal is to evaluate the Donor Plan Donor Choice tool to promote high-quality Shared Decision Making for providers and kidney transplant candidates at two transplant centers.\n\nParticipants will:\n\n* Review an online education tool, Donor Plan Donor Choice.\n* Discuss a Kidney Offer Plan with a transplant provider.\n* Answer questions about willingness to consider different donor types.\n\nResearchers will compare the Shared Decision Making group to usual care to generate pilot data and implementation outcomes for a larger trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Candidate on the kidney transplant waiting list\n* Greater than 3 months since listing for transplant\n* 18 Years of age or older\n* English-speaking\n\nExclusion Criteria:\n\n* Non-English speaking\n* \\< 18 years of age\n* Patients who choose to opt out of research.\n* Unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT05879302', 'briefTitle': 'Shared Decision Making for Kidney Transplant Candidates to Plan for an Organ Offer Decision', 'organization': {'class': 'OTHER', 'fullName': 'Hennepin Healthcare Research Institute'}, 'officialTitle': 'Shared Decision Making for Kidney Transplant Candidates to Plan for an Organ Offer Decision', 'orgStudyIdInfo': {'id': 'Pro00067603'}, 'secondaryIdInfos': [{'id': '1R01DK134482', 'link': 'https://reporter.nih.gov/quickSearch/1R01DK134482', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Shared Decision Making Intervention', 'description': 'Receives the Shared Decision Making Intervention', 'interventionNames': ['Behavioral: Kidney Offer Shared Decision Making']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Receives Usual Care, eg. usual patient education and counseling for kidney transplant candidates.'}], 'interventions': [{'name': 'Kidney Offer Shared Decision Making', 'type': 'BEHAVIORAL', 'description': 'The intervention consists of receiving the Donor Offer Plan (DOP), reviewing a web-based educational module about donor offers including practice offer videos, followed by a discussion about the DOP with a transplant nurse coordinator.', 'armGroupLabels': ['Shared Decision Making Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55415', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cory Schaffhausen', 'role': 'CONTACT', 'email': 'schaf390@umn.edu', 'phone': '612-873-5300'}], 'facility': 'Hennepin Healthcare', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kasey Boehmer', 'role': 'CONTACT', 'email': 'Boehmer.Kasey@mayo.edu', 'phone': '507-422-5538'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Cory Schaffhausen', 'role': 'CONTACT', 'email': 'schaf390@umn.edu', 'phone': '(612) 873-5300'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hennepin Healthcare Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mayo Clinic', 'class': 'OTHER'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Cory Schaffhausen', 'investigatorAffiliation': 'Hennepin Healthcare Research Institute'}}}}