Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-05 @ 9:43 AM
Study NCT ID:
NCT06638632
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-16
First Post:
2024-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decision Aid for Dementia Therapies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003661', 'term': 'Decision Support Techniques'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is an iterative, user-centered design process. Therefore, patients and care partners will receive iterations of the decision aid as updates are made to it.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-12', 'studyFirstSubmitDate': '2024-10-04', 'studyFirstSubmitQcDate': '2024-10-10', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decisional Conflict', 'timeFrame': 'From enrollment at start of year 2 to the end of year 2', 'description': "To access the preliminary efficacy on decisional conflict including personal perceptions of uncertainty in choosing options, factors that contribute to feelings of uncertainty and effective decision making.\n\nDecisional Conflict Scale - Higher numbers mean more uncertainty. O'Connor, A. M. (1995). Validation of a decisional conflict scale. Medical decision making, 15(1), 25-30. https://decisionaid.ohri.ca/docs/develop/User\\_Manuals/UM\\_Decisional\\_Conflict.pdf"}, {'measure': 'Shared Decision Making', 'timeFrame': 'From enrollment at start of year 2 to the end of year 2', 'description': "To determine the extent that health care providers engage with patients as a part of their shared decision making, specifically looking at the discussion of treatment options and their pros and cons as well as the patient's preferences.\n\nShared Decision Making Process Scale - Higher numbers mean more shared decision making. https://mghdecisionsciences.org/tools-training/sdm-process-survey/"}, {'measure': 'Decisional Self-Efficacy', 'timeFrame': 'From enrollment at start of year 2 to the end of year 2', 'description': "To determine the patient's perception of their self-efficacy in decision making including measuring their self-confidence in their ability to make decisions.\n\nDecision Self-Efficacy Scale where higher numbers mean they patient has a higher perception of self-efficacy.\n\nhttps://decisionaid.ohri.ca/docs/develop/Tools/Decision\\_SelfEfficacy.pdf"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lecanemab'], 'conditions': ['Dementia', 'Decision Aids']}, 'referencesModule': {'references': [{'pmid': '21088131', 'type': 'BACKGROUND', 'citation': 'Elwyn G, Frosch D, Volandes AE, Edwards A, Montori VM. Investing in deliberation: a definition and classification of decision support interventions for people facing difficult health decisions. Med Decis Making. 2010 Nov-Dec;30(6):701-11. doi: 10.1177/0272989X10386231. Epub 2010 Nov 18.'}, {'pmid': '36449413', 'type': 'BACKGROUND', 'citation': "van Dyck CH, Swanson CJ, Aisen P, Bateman RJ, Chen C, Gee M, Kanekiyo M, Li D, Reyderman L, Cohen S, Froelich L, Katayama S, Sabbagh M, Vellas B, Watson D, Dhadda S, Irizarry M, Kramer LD, Iwatsubo T. Lecanemab in Early Alzheimer's Disease. N Engl J Med. 2023 Jan 5;388(1):9-21. doi: 10.1056/NEJMoa2212948. Epub 2022 Nov 29."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop a decision aid to support patients and families making decisions about medications for dementia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients:\n\n* UCHealth patient\n* Ages 18 y/o and above\n* Documented neurocognitive deficits suggestive of mild cognitive impairment or early dementia as determined by their treating clinician.\n* English or Spanish speaking\n\nCaregiver:\n\n* Ages 18 y/o and above\n* Identified by the study participant as the person who helps the most with their medical care outside the hospital or clinic.\n* English or Spanish speaking\n\nClinicians:\n\n* Neurologists, primary care clinicians, pharmacists, or psychologists involved in dementia decision-making.\n* English or Spanish speaking\n\nExclusion Criteria:\n\nPatients:\n\n* Not English or Spanish-speaking\n* Neurocognitive deficits suggestive of moderate or severe cognitive impairment or late stage dementia.\n* Not able to consent for themselves\n\nCaregiver:\n\n* Ages 17 y/o and below\n* Not English or Spanish-speaking\n\nClinicians:\n\n* Neurologists, primary care clinicians, pharmacists, or psychologists involved in dementia decision-making.\n* English or Spanish-speaking'}, 'identificationModule': {'nctId': 'NCT06638632', 'briefTitle': 'Decision Aid for Dementia Therapies', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Helping Patients, Families, and Clinicians Make Shared Decisions About Therapies for Dementia', 'orgStudyIdInfo': {'id': '24-0866'}, 'secondaryIdInfos': [{'id': 'NIA Grant#: R21AG088955', 'type': 'OTHER_GRANT', 'domain': 'NIA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Decision Aid', 'description': 'Participants provide feedback on the development of a decision aid for dementia therapies.', 'interventionNames': ['Behavioral: Decision aid']}], 'interventions': [{'name': 'Decision aid', 'type': 'BEHAVIORAL', 'description': 'Patients with dementia and care partners will receive an iteration of the decision aid and provide feedback.', 'armGroupLabels': ['Decision Aid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'contacts': [{'name': 'Kaitlynn Walton, MPH', 'role': 'CONTACT', 'email': 'kaitlynn.walton@cuanschutz.edu', 'phone': '303-724-7162'}, {'name': 'Kate Noonan', 'role': 'CONTACT', 'email': 'kate.noonan@cuanschutz.edu'}, {'name': 'Daniel Matlock', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'centralContacts': [{'name': 'Kaitlynn Walton, MPH', 'role': 'CONTACT', 'email': 'kaitlynn.walton@cuanschutz.edu', 'phone': '303-724-7162'}, {'name': 'Kate Noonan, MSW', 'role': 'CONTACT', 'email': 'kate.noonan@cuanschutz.edu', 'phone': '303-618-2181'}], 'overallOfficials': [{'name': 'Dan Matlock, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}