Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-02-21 @ 1:33 AM
Study NCT ID:
NCT04754932
Status:
COMPLETED
Last Update Posted:
2023-04-14
First Post:
2021-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation of Cognitive Stimulation Therapy
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-12', 'studyFirstSubmitDate': '2021-02-05', 'studyFirstSubmitQcDate': '2021-02-11', 'lastUpdatePostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of participants who were eligible for Cognitive Stimulation Therapy but were excluded from participation', 'timeFrame': '2 years'}, {'measure': 'Change in cognitive status as measured by Saint Louis University Mental Status Examination', 'timeFrame': 'Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month', 'description': 'A validated 30 point office-based cognitive screen'}, {'measure': 'Change in anxiety/depression as measured by Cornell Scale for Depression in Dementia', 'timeFrame': 'Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month', 'description': 'A validated 19 point scale to identify anxiety/depression symptoms in patients with moderate to severe dementia.'}, {'measure': 'Change in quality of life as evaluated by ICEpop CAPability measure for Older people (ICECAP-O)', 'timeFrame': 'Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month', 'description': 'A 5-point scale measuring general well-being/quality of life for older adults'}, {'measure': 'Change in behavioral symptom severity as measured by the Neuropsychiatric Inventory', 'timeFrame': 'Baseline, end-of-protocol (7 weeks), 3-month, 6-month, 12-month', 'description': 'A validated 12-domain questionnaire to assess dementia-related behavioral symptoms'}, {'measure': 'Adoption as measured by the percentage of non-participating centers to the total number approached.', 'timeFrame': '2 years'}, {'measure': 'Number of CST groups adhering to 18 components of therapy protocol assessed by direct observation using a checklist.', 'timeFrame': '1 year'}, {'measure': 'Maintenance as measured by percentage of long-term attrition', 'timeFrame': '2 years'}, {'measure': 'Assess the barriers and facilitators to implementation of CST in community settings', 'timeFrame': '1 year', 'description': 'Focus groups will be held to better understand the barriers and facilitators to adoption at both the setting level and individual level. These focus groups will also be used to assess implementation by gathering data on adherence to the prescribed CST protocol and any adaptations made to the CST intervention.\n\nImplementation fidelity will be assessed by direct observation of the CST groups by members of the research team using a checklist to describe adherence to key components of the protocol. Implementation barriers will be assessed through the use of focus groups and questionnaires. Based on collected data on implementation barriers and process measures, we will develop strategies to improve fidelity of the intervention and to enhance reach.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dementia']}, 'descriptionModule': {'briefSummary': 'This project aims to examine the feasibility of implementing Cognitive Stimulation Therapy (CST) under real world circumstances in a more heterogenous population, with the ultimate goal of making the treatment broadly accessible. The effects of CST on the behavioral and psychological symptoms of dementia (BPSD) as a non-pharmacologic intervention will also be studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* established diagnosis of dementia or meets the criteria for dementia based on a positive screening test with clinical evidence of cognitive impairment affecting one or more ADL\n* has a SLUMS score greater than 10.\n\nExclusion Criteria:\n\n* unable to hold a meaningful conversation,\n* unable to hear well enough to participate in a small group discussion\n* severe visual impairment that precludes ability to see most pictures\n* unable to remain in a group setting for 45 minutes'}, 'identificationModule': {'nctId': 'NCT04754932', 'briefTitle': 'Implementation of Cognitive Stimulation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Implementation of Cognitive Stimulation Therapy Across a Healthcare System to Improve Clinical Outcomes of Individuals Living With Dementing Illnesses', 'orgStudyIdInfo': {'id': 'Pro00106751'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Community Site 1', 'description': 'CST Implementation community site', 'interventionNames': ['Other: Cognitive Stimulation Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Community Site 2', 'description': 'CST Implementation community site', 'interventionNames': ['Other: Cognitive Stimulation Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Community Site 3', 'description': 'CST Implementation community site', 'interventionNames': ['Other: Cognitive Stimulation Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Community Site 4', 'description': 'CST Implementation community site', 'interventionNames': ['Other: Cognitive Stimulation Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Community Site 5', 'description': 'CST Implementation community site', 'interventionNames': ['Other: Cognitive Stimulation Therapy']}], 'interventions': [{'name': 'Cognitive Stimulation Therapy', 'type': 'OTHER', 'description': 'Group-based therapy for people living with mild to moderate stage dementia, delivered by two trained facilitators.', 'armGroupLabels': ['Community Site 1', 'Community Site 2', 'Community Site 3', 'Community Site 4', 'Community Site 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27701', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Durham Center for Senior Life', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27703', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Program for All Inclusive Care of the Elderly', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The Forest at Duke', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27405', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Program for All Inclusive Care of the Elderly', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}], 'overallOfficials': [{'name': 'Milta Little, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}