Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-31 @ 1:49 PM
Study NCT ID:
NCT01708304
Status:
COMPLETED
Last Update Posted:
2017-09-15
First Post:
2012-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing Disabilities in Alzheimer's Disease (RDAD) Translation in Area Agencies on Aging (AAAs)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D008569', 'term': 'Memory Disorders'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 510}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-14', 'studyFirstSubmitDate': '2012-10-09', 'studyFirstSubmitQcDate': '2012-10-15', 'lastUpdatePostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Minutes of exercise per week', 'timeFrame': 'Change from baseline in number of minutes of exercise each week during treatment phase of study, weeks 7-12', 'description': 'Caregivers will track the number of minutes per week the care recipients engage in exercise recommended by the coach.'}, {'measure': 'Restricted Activity Days', 'timeFrame': 'Baseline', 'description': 'Restricted Activity Days measures how much the participant cut down his/her usual activities in the previous two weeks because of injury or illness and how many days the participant stayed in bed in the previous two weeks because of injury or illness.'}, {'measure': 'Restricted Activity Days', 'timeFrame': 'Change from Baseline to Pre-Treatment (6 weeks)', 'description': 'Restricted Activity Days measures how much the participant cut down his/her usual activities in the previous two weeks because of injury or illness and how many days the participant stayed in bed in the previous two weeks because of injury or illness.'}, {'measure': 'Restricted Activity Days', 'timeFrame': 'Change from Baseline to Post- Treatment 1 (13 weeks)', 'description': 'Restricted Activity Days measures how much the participant cut down his/her usual activities in the previous two weeks because of injury or illness and how many days the participant stayed in bed in the previous two weeks because of injury or illness.'}, {'measure': 'Restricted Activity Days', 'timeFrame': 'Change from Baseline to Post-Treatment 2 (30 weeks)', 'description': 'Restricted Activity Days measures how much the participant cut down his/her usual activities in the previous two weeks because of injury or illness and how many days the participant stayed in bed in the previous two weeks because of injury or illness.'}, {'measure': 'Restricted Days of Activity', 'timeFrame': 'Change from Baseline to 13 Month Follow-Up', 'description': 'Restricted Activity Days measures how much the participant cut down his/her usual activities in the previous two weeks because of injury or illness and how many days the participant stayed in bed in the previous two weeks because of injury or illness.'}, {'measure': 'Independence/Residential Status', 'timeFrame': 'Change from Baseline to 13 Month Follow-Up', 'description': 'All participants will be in independent living situations at baseline. Any move from independent living to a care facility will be documented throughout the 13 month study.'}], 'secondaryOutcomes': [{'measure': 'Revised Memory and Behavior Problem Checklist (RMBPC)', 'timeFrame': 'Baseline', 'description': 'Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.'}, {'measure': 'Revised Memory and Behavior Problem Checklist (RMBPC)', 'timeFrame': 'Change from Baseline to Pre-Treatment (6 weeks)', 'description': 'Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.'}, {'measure': 'Revised Memory and Behavior Problem Checklist (RMBPC)', 'timeFrame': 'Change from Baseline to Post-Treatment 1 (13 weeks)', 'description': 'Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.'}, {'measure': 'Revised Memory and Behavior Problem Checklist (RMBPC)', 'timeFrame': 'Change from Baseline to Post-Treatment 2 (30 weeks)', 'description': 'Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.'}, {'measure': 'Revised Memory and Behavior Problem Checklist (RMBPC)', 'timeFrame': 'Change from Baseline to 13 Month Follow-Up', 'description': 'Checklist rates 24 care recipient behaviors for frequency of occurrence and caregiver reaction.'}, {'measure': 'Quality of Life-AD', 'timeFrame': 'Baseline', 'description': 'This 13-item measure is specifically designed for individuals with dementia and focuses on quality of life domains identified as important for cognitively impaired older adults.'}, {'measure': 'Quality of Life-AD', 'timeFrame': 'Change from Baseline to Pre-Treatment (6 weeks)', 'description': 'This 13-item measure is specifically designed for individuals with dementia and focuses on quality of life domains identified as important for cognitively impaired older adults.'}, {'measure': 'Quality of Life-AD', 'timeFrame': 'Change from Baseline to Post-Treatment 1 (13 weeks)', 'description': 'This 13-item measure is specifically designed for individuals with dementia and focuses on quality of life domains identified as important for cognitively impaired older adults.'}, {'measure': 'Quality of Life-AD', 'timeFrame': 'Change from Baseline to Post-Treatment 2 (30 weeks)', 'description': 'This 13-item measure is specifically designed for individuals with dementia and focuses on quality of life domains identified as important for cognitively impaired older adults.'}, {'measure': 'Quality of Life-AD', 'timeFrame': 'Change from Baseline to 13 Month Follow-Up', 'description': 'This 13-item measure is specifically designed for individuals with dementia and focuses on quality of life domains identified as important for cognitively impaired older adults.'}, {'measure': 'CES-D', 'timeFrame': 'Baseline', 'description': 'This 20-item scale that assesses depression in caregivers.'}, {'measure': 'CES-D', 'timeFrame': 'Change from Baseline to Pre-Treatment (6 weeks)', 'description': 'A 20-item scale that assesses depression in caregivers.'}, {'measure': 'CES-D', 'timeFrame': 'Change from Baseline to Post-Treatment 1 (13 weeks)', 'description': 'A 20-item scale that assesses depression in caregivers.'}, {'measure': 'CES-D', 'timeFrame': 'Change from Baseline to Post-Treatment 2 (30 weeks)', 'description': 'A 20-item scale that assesses depression in caregivers.'}, {'measure': 'CES-D', 'timeFrame': 'Change from Baseline to 13 Month Follow-Up', 'description': 'A 20-item scale that assesses depression in caregivers.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dementia', "Alzheimer's Disease", 'Exercise', 'Caregiver', 'Behavior modification'], 'conditions': ["Alzheimer's Disease", 'Dementia', 'Memory Impairment', 'Cognitive Impairment']}, 'referencesModule': {'references': [{'pmid': '30304477', 'type': 'DERIVED', 'citation': 'Teri L, Logsdon RG, McCurry SM, Pike KC, McGough EL. Translating an Evidence-based Multicomponent Intervention for Older Adults With Dementia and Caregivers. Gerontologist. 2020 Apr 2;60(3):548-557. doi: 10.1093/geront/gny122.'}]}, 'descriptionModule': {'briefSummary': "The University of Washington's Northwest Research Group on Aging is partnering with Area Agencies on Aging (AAA) in Washington and Oregon to complete this translational investigation of RDAD (Reducing Disabilities in Alzheimer's Disease). RDAD is an evidence-based program with demonstrated efficacy in helping older adults with dementia maintain physical function and remain physically and mentally healthy. This study asks two questions: 1) Can AAA partners successfully translate and implement RDAD, and 2) Is AAA implementation of RDAD effective in producing desired outcomes among agencies, providers, and older adults with dementia and their family members. This study is being conducted in Washington and Oregon states."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCare Recipients must\n\n* Have a diagnosis of dementia\n* Be 65 years of age or older\n* Currently exercise no more than 150 minutes a week and not regularly participate in a formal exercise program.\n\nCaregivers must\n\n* Live in the community\n* Provide care to the care recipient with dementia\n\nExclusion Criteria:\n\nEither Care-recipient or Caregiver must not\n\n* Plan to move to a long-term residential care setting within 6 months of enrollment.\n* Plan to move from the study geographic area within 4 months of enrollment.\n* Have a known terminal illness (with death anticipated within the next 12 months)\n* Have had a hospitalization for a psychiatric disorder in the 12 months prior to baseline\n* Be actively suicidal, hallucinating, or delusional\n* Be blind, deaf, or not ambulatory'}, 'identificationModule': {'nctId': 'NCT01708304', 'acronym': 'RDAD', 'briefTitle': "Reducing Disabilities in Alzheimer's Disease (RDAD) Translation in Area Agencies on Aging (AAAs)", 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'From Evidence-Base to Practice: Implementing RDAD in AAA Community-Based Services', 'orgStudyIdInfo': {'id': '41906'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'RDAD', 'description': 'Exercise training for caregiver and care recipient. Behavior modification training for caregiver.', 'interventionNames': ['Behavioral: RDAD']}], 'interventions': [{'name': 'RDAD', 'type': 'BEHAVIORAL', 'description': 'Exercise training for caregiver and care recipient. Behavioral modification training for caregiver.', 'armGroupLabels': ['RDAD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Linda Teri, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Psychosocial & Community Health', 'investigatorFullName': 'Linda Teri', 'investigatorAffiliation': 'University of Washington'}}}}