Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-26 @ 6:14 AM
Study NCT ID:
NCT04350060
Status:
COMPLETED
Last Update Posted:
2025-08-29
First Post:
2019-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving the Quality of Dementia Care Through Innovative Redesign of the Memory Care Environment
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2019-12-18', 'studyFirstSubmitQcDate': '2020-04-14', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in emergency room and hospitalizations', 'timeFrame': 'monthly for up to one year', 'description': "Measured using recorded emergency room and hospitalization data from patient's chart."}], 'primaryOutcomes': [{'measure': "Change in quality of life, as measured by the Quality of Life in Alzheimer's disease (QOL-AD)", 'timeFrame': 'every 2 weeks for up to one year', 'description': 'Measured using the self-reported QOL-AD questionnaire comprised of 13 questions with a scale of poor = 1, fair = 2, good = 3, excellent =4. Scores range from 13 to 52, with higher scored indicating better quality of life.'}, {'measure': 'Change in sleep quality, as measured by the Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'every 2 weeks for up to one year', 'description': 'Measured using the self-reported PSQI that uses 9 questions regarding sleep quality to determine a final score where a total of "5" or greater is indicative of poor sleep quality.'}, {'measure': 'Change in dementia related behaviors and delirium, as measured by the Neuropsychiatric Inventory-Questionnaire (NPI-Q)', 'timeFrame': 'every 2 weeks for up to one year', 'description': 'Measured using the self-reported NPI-Q questionnaire that reports Yes = present or No = absent on 12 domains. If yes, then the informant rates the severity of the symptoms on a 3-point scale (1 = mild, 2 = moderate, 3 = severe) and the distress of the symptoms on a 5-point scale (0 = not distressing at all, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = extreme or very severe).'}, {'measure': 'Change in mood, as measured by the Patient Health Questionnaire 9 (PHQ-9)', 'timeFrame': 'every 2 weeks for up to one year', 'description': 'Measured using the self-reported PHQ-9 questionnaire that uses 9 question regarding patient health with a sale of not at all = 0, several days = 1, more than half the days = 2, nearly everyday =3. Scores range from 0 to 27, with higher scored indicating grater severity of depression.'}, {'measure': 'Change in function and independence, as measured by the Katz Index of Independence in Activities of Daily living (KATZ)', 'timeFrame': 'every 2 weeks for up to one year', 'description': 'Measured using the self-reported KATZ questionnaire with a scale of independence = 1 and dependence = 0 to determine total score. The KATZ ranges from 0 to 6 with the lower score indicated patient is very dependent and the higher score indicated patient is independent.'}, {'measure': 'Change in medication use', 'timeFrame': 'every 2 weeks for up to one year', 'description': "Measured using recorded medication use from patient's chart."}, {'measure': 'Change in falls', 'timeFrame': 'monthly for up to one year', 'description': "Measured using recorded fall data from patient's chart."}], 'secondaryOutcomes': [{'measure': 'Change in caregiver burden, as measured by the Caregiver Strain Index (CSI)', 'timeFrame': '6 months', 'description': 'Measured using the self-reported CSI questionnaire with a scale of Yes=1 and No=0. Total score of 7 or higher indicates a high level of stress.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dementia']}, 'descriptionModule': {'briefSummary': 'Research study is being done to demonstrate novel opportunities to transform the way the dementia community is cared for.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients currently residing at Arbor Terrace memory care unit\n* Patients diagnosed with dementia\n\nExclusion Criteria:\n\n* Hospice patients with less than 30 days of life expectancy at the time of enrollment'}, 'identificationModule': {'nctId': 'NCT04350060', 'briefTitle': 'Improving the Quality of Dementia Care Through Innovative Redesign of the Memory Care Environment', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Memory Care of the Future: Improving the Quality of Dementia Care Through Innovative Redesign of the Memory Care Environment', 'orgStudyIdInfo': {'id': '18-002202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Subjects with dementia will be living in a retro-fitted room with technological enhancements for a 12 month period.', 'interventionNames': ['Other: Retro-fitted room with technological enhancements']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care Group'}], 'interventions': [{'name': 'Retro-fitted room with technological enhancements', 'type': 'OTHER', 'description': 'Reconstructing and retrofitting a currently existing memory care room at Samaritan Bethany Arbor Terrace Senior Living with integrated technologies specifically to accommodate the needs of persons with dementia to enhance sensory stimulation in sight, sound and sleep.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Ying Ying Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ying Ying (Christina) Chen', 'investigatorAffiliation': 'Mayo Clinic'}}}}