Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT00079651
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2004-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Montessori-Based Activities for Elderly Persons With Dementia
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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-21', 'studyFirstSubmitDate': '2004-03-10', 'studyFirstSubmitQcDate': '2004-03-11', 'lastUpdatePostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Aged', 'Nursing Homes', 'Assisted Living Facilities'], 'conditions': ['Dementia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.myersresearch.org', 'label': 'Click here to contact Myers Research Institute regarding this study'}]}, 'descriptionModule': {'briefSummary': 'This study will determine whether montessori-based activities can help older adults with dementia become more responsive to others.', 'detailedDescription': "Studies have shown that Montessori-based activities, which focus on developing an individual's unique abilities, are effective in increasing engagement between nursing home residents with dementia and their caregivers. This study will determine whether the positive effects of Montessori-based programming can be replicated in adult day care, assisted living, and nursing homes. Results from this study will be used to create training materials to help staff in different settings implement the intervention within existing schedules, staffing, and programming routines.\n\nThis study will be conducted in two phases. During Phase I, participants with mild dementia will be trained to become small group leaders for Montessori-based activities. In Phase II, newly-trained participants will use their skills to assist others. Assessments will be made throughout the study. Participants' engagement with the environment and caregiver burden and satisfaction will be assessed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of dementia\n* Living in or attending programs at participating sites\n\nExclusion Criteria:\n\n* Medical conditions that would interfere with study participation'}, 'identificationModule': {'nctId': 'NCT00079651', 'briefTitle': 'Montessori-Based Activities for Elderly Persons With Dementia', 'organization': {'class': 'OTHER', 'fullName': 'Menorah Park'}, 'officialTitle': 'Programming for Dementia: Maximizing Abilities', 'orgStudyIdInfo': {'id': 'R21MH063395', 'link': 'https://reporter.nih.gov/quickSearch/R21MH063395', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R21MH063395', 'link': 'https://reporter.nih.gov/quickSearch/R21MH063395', 'type': 'NIH'}, {'id': 'DATR A4-GPS'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Montessori-based dementia programming', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44122', 'city': 'Beachwood', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mandel Adult Day Program', 'geoPoint': {'lat': 41.4645, 'lon': -81.50873}}, {'zip': '44122', 'city': 'Beachwood', 'state': 'Ohio', 'country': 'United States', 'facility': 'Stone Gardens', 'geoPoint': {'lat': 41.4645, 'lon': -81.50873}}, {'zip': '44103', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Eliza Bryant Village', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44125', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Jennings Center for Older Adults', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44124', 'city': 'Lyndhurst', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Greens Adult Living Communities', 'geoPoint': {'lat': 41.52005, 'lon': -81.48873}}], 'overallOfficials': [{'name': 'Cameron J. Camp, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Myers Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menorah Park', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}