Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT05996718
Status:
COMPLETED
Last Update Posted:
2025-06-11
First Post:
2023-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Improving Care Through Improv: Promoting Mastery in the Moment
Sponsor:
Organization:
Raw JSON
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During the intervention, participants attended four 2-hour weekly in-person group classes designed to enhance caregiver mastery and improve well-being among family members and friends providing care to someone living with dementia.', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pearlin Mastery, Loss, and Competence: Caregiver Competence Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Caregivers', 'description': 'Caregiver of a person living with dementia participating in the Improving Care through Improv intervention. During the intervention, participants attended four 2-hour weekly in-person group classes designed to enhance caregiver mastery and improve well-being among family members and friends providing care to someone living with dementia.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.10', 'spread': '2.31', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.63', 'spread': '2.07', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.93', 'spread': '2.06', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at baseline, upon training completion (Week 4), and three months post baseline.', 'description': '4-item Likert-type scale; scores range from 4 to 16 with higher scores indicating greater feelings of competence.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Forty-three caregivers began the study; 42 completed the survey at Month 1; 40 completed the month 3 survey.'}, {'type': 'SECONDARY', 'title': 'Perceived Stress Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Caregivers', 'description': 'Caregiver of a person living with dementia participating in the Improving Care through Improv intervention. During the intervention, participants attended four 2-hour weekly in-person group classes designed to enhance caregiver mastery and improve well-being among family members and friends providing care to someone living with dementia.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.25', 'spread': '8.43', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.65', 'spread': '9.45', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.10', 'spread': '8.16', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at baseline, upon training completion (Week 4), and three months post baseline.', 'description': '14-item Likert-type scale. Scores range from 0 to 56 with higher scores indicating greater stress.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Forty-three caregivers began the study; 42 completed the survey at Month 1; 40 completed the month 3 survey.'}, {'type': 'SECONDARY', 'title': 'Center for Epidemiological Studies-Depression Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Caregivers', 'description': 'Caregiver of a person living with dementia participating in the Improving Care through Improv intervention. During the intervention, participants attended four 2-hour weekly in-person group classes designed to enhance caregiver mastery and improve well-being among family members and friends providing care to someone living with dementia.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.83', 'spread': '9.30', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.78', 'spread': '9.45', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.98', 'spread': '9.40', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at baseline, upon training completion (Week 4), and three months post baseline.', 'description': '20-item Likert-type scale. Scores range from 0 to 60 with higher scores indicating greater depression.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Forty-three caregivers began the study; 42 completed the survey at Month 1; 40 completed the month 3 survey.'}, {'type': 'SECONDARY', 'title': 'State-Trait Anxiety Inventory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Caregivers', 'description': 'Caregiver of a person living with dementia participating in the Improving Care through Improv intervention. During the intervention, participants attended four 2-hour weekly in-person group classes designed to enhance caregiver mastery and improve well-being among family members and friends providing care to someone living with dementia.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.15', 'spread': '10.27', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.38', 'spread': '11.09', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34.85', 'spread': '11.62', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at baseline, upon training completion (Week 4), and three months post baseline.', 'description': '20-item Likert-type scale. Scores range from 20 to 80 with higher scores indicating greater anxiety.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Forty-three caregivers began the study; 42 completed the survey at Month 1; 40 completed the month 3 survey.'}, {'type': 'SECONDARY', 'title': 'Zarit Burden Inventory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Caregivers', 'description': 'Caregiver of a person living with dementia participating in the Improving Care through Improv intervention. During the intervention, participants attended four 2-hour weekly in-person group classes designed to enhance caregiver mastery and improve well-being among family members and friends providing care to someone living with dementia.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '61.95', 'spread': '16.32', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '61.63', 'spread': '15.19', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59.68', 'spread': '16.43', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at baseline, upon training completion (Week 4), and three months post baseline.', 'description': '22-item scale with 4-point Likert scale responses. Scores range from 0 to 88 with higher scores indicating greater burden.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Forty-three caregivers began the study; 42 completed the survey at Month 1; 40 completed the month 3 survey.'}, {'type': 'SECONDARY', 'title': 'Revised Memory and Behavioral Problems Checklist - FREQUENCY', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Caregivers', 'description': 'Caregiver of a person living with dementia participating in the Improving Care through Improv intervention. During the intervention, participants attended four 2-hour weekly in-person group classes designed to enhance caregiver mastery and improve well-being among family members and friends providing care to someone living with dementia.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37.20', 'spread': '14.21', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.55', 'spread': '11.99', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38.05', 'spread': '13.78', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at baseline, upon training completion (Week 4), and three months post baseline.', 'description': '24-item scale with 4-point Likert scale responses. Scores range from 0 to 96 with higher scores indicating greater behavioral expressions observed by caregivers among persons living with dementia.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Forty-three caregivers began the study; 42 completed the survey at Month 1; 40 completed the month 3 survey.'}, {'type': 'SECONDARY', 'title': "Quality of Life-Alzheimer's Disease Scale", 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Caregivers', 'description': 'Caregiver of a person living with dementia participating in the Improving Care through Improv intervention. 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Scores range from 13 to with 52 with higher scores indicating greater quality of life among persons living with dementia', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Forty-three caregivers began the study; 42 completed the survey at Month 1; 40 completed the month 3 survey.'}, {'type': 'SECONDARY', 'title': 'Revised Memory and Behavioral Problems Checklist - REACTION', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Caregivers', 'description': 'Caregiver of a person living with dementia participating in the Improving Care through Improv intervention. During the intervention, participants attended four 2-hour weekly in-person group classes designed to enhance caregiver mastery and improve well-being among family members and friends providing care to someone living with dementia.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.13', 'spread': '13.27', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.70', 'spread': '12.21', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.35', 'spread': '12.05', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at baseline, upon training completion (Week 4), and three months post baseline.', 'description': '24-item scale with 4-point Likert scale responses. Scores range from 0 to 96 with higher scores indicating greater behavioral expressions observed by caregivers among persons living with dementia.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Forty-three caregivers began the study; 42 completed the survey at Month 1; 40 completed the month 3 survey.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Caregivers', 'description': 'Caregiver of a person living with dementia participating in the Improving Care through Improv intervention. During the intervention, participants attended four 2-hour weekly in-person group classes designed to enhance caregiver mastery and improve well-being among family members and friends providing care to someone living with dementia.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}]}, {'type': 'Completed Month 1 Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Caregivers', 'description': 'Caregiver of a person living with dementia participating in the Improving Care through Improv intervention. During the intervention, participants attended four 2-hour weekly in-person group classes designed to enhance caregiver mastery and improve well-being among family members and friends providing care to someone living with dementia.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.87', 'groupId': 'BG000', 'lowerLimit': '34', 'upperLimit': '81'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'This study was conducted in Atlanta, Georgia, USA.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-27', 'size': 280276, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-05-18T19:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2023-08-10', 'resultsFirstSubmitDate': '2025-05-18', 'studyFirstSubmitQcDate': '2023-08-10', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-10', 'studyFirstPostDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pearlin Mastery, Loss, and Competence: Caregiver Competence Subscale', 'timeFrame': 'at baseline, upon training completion (Week 4), and three months post baseline.', 'description': '4-item Likert-type scale; scores range from 4 to 16 with higher scores indicating greater feelings of competence.'}], 'secondaryOutcomes': [{'measure': 'Perceived Stress Scale', 'timeFrame': 'at baseline, upon training completion (Week 4), and three months post baseline.', 'description': '14-item Likert-type scale. Scores range from 0 to 56 with higher scores indicating greater stress.'}, {'measure': 'Center for Epidemiological Studies-Depression Scale', 'timeFrame': 'at baseline, upon training completion (Week 4), and three months post baseline.', 'description': '20-item Likert-type scale. Scores range from 0 to 60 with higher scores indicating greater depression.'}, {'measure': 'State-Trait Anxiety Inventory', 'timeFrame': 'at baseline, upon training completion (Week 4), and three months post baseline.', 'description': '20-item Likert-type scale. Scores range from 20 to 80 with higher scores indicating greater anxiety.'}, {'measure': 'Zarit Burden Inventory', 'timeFrame': 'at baseline, upon training completion (Week 4), and three months post baseline.', 'description': '22-item scale with 4-point Likert scale responses. Scores range from 0 to 88 with higher scores indicating greater burden.'}, {'measure': 'Revised Memory and Behavioral Problems Checklist - FREQUENCY', 'timeFrame': 'at baseline, upon training completion (Week 4), and three months post baseline.', 'description': '24-item scale with 4-point Likert scale responses. Scores range from 0 to 96 with higher scores indicating greater behavioral expressions observed by caregivers among persons living with dementia.'}, {'measure': "Quality of Life-Alzheimer's Disease Scale", 'timeFrame': 'at baseline, upon training completion (Week 4), and three months post baseline.', 'description': '13 items with a 4-point Likert scale. Scores range from 13 to with 52 with higher scores indicating greater quality of life among persons living with dementia'}, {'measure': 'Revised Memory and Behavioral Problems Checklist - REACTION', 'timeFrame': 'at baseline, upon training completion (Week 4), and three months post baseline.', 'description': '24-item scale with 4-point Likert scale responses. Scores range from 0 to 96 with higher scores indicating greater behavioral expressions observed by caregivers among persons living with dementia.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Caregiver Burden']}, 'descriptionModule': {'briefSummary': 'The goals of this clinical trial are to: 1) refine the training program, "Improving Care though Improv;" and 2) test the program for its influence self-perceived caregiving mastery (i.e., how persons assess their ability to provide care) among informal caregivers of persons living with moderate dementia. Forty-three informal caregivers will be involved in testing the training program. These individuals will be assigned to groups of between 8 to12 caregivers and take part in weekly 2-hour sessions held over a 4-week period. These caregivers will be taught improvisational (improv) theater skills, which involves being in the moment, self-awareness, and responsiveness to others. This group also will be asked to answer surveys questions about themselves and the person receiving care at three timepoints and invited to provide feedback on their training experiences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Actively engaged in the care of community-dwelling persons living with moderate dementia (4 or 5 on a 7-point dementia-staging scale) who is not likely to be institutionalized within the next 6 months\n* Able to attend at least 3 of the 4 in-person sessions\n* Ability to communicate in English\n\nExclusion Criteria: Potential participants were excluded if they did not meet the above criteria or anticipated moving their person to a skilled nursing facility within the next 6 months.'}, 'identificationModule': {'nctId': 'NCT05996718', 'briefTitle': 'Improving Care Through Improv: Promoting Mastery in the Moment', 'organization': {'class': 'OTHER', 'fullName': 'Georgia State University'}, 'officialTitle': 'Improving Care Through Improv: Promoting Mastery in the Moment', 'orgStudyIdInfo': {'id': 'P30AG064200', 'link': 'https://reporter.nih.gov/quickSearch/P30AG064200', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'DBSR-11114', 'type': 'OTHER', 'domain': 'NIA CROMS'}, {'id': 'P30AG064200', 'link': 'https://reporter.nih.gov/quickSearch/P30AG064200', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Informal Caregivers of Persons Living with Dementia', 'description': 'Participants will receive the training program, "Improving Care through Improv." This involves four weekly 2-hour in-person training sessions.', 'interventionNames': ['Behavioral: Training program pilot']}], 'interventions': [{'name': 'Training program pilot', 'type': 'BEHAVIORAL', 'description': 'This intervention for informal caregivers consists of training that will introduce participants to improvisational (improv) theatre and teach its core communication skills.', 'armGroupLabels': ['Informal Caregivers of Persons Living with Dementia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30302', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia State University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Candace L Kemp, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Georgia State Univeristy'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Study data will be made available no later than the on-line publication date of the main findings from the final dataset.', 'ipdSharing': 'YES', 'description': 'Data from this study will be made available to qualified researchers through a data sharing agreement that is consistent with NIH data sharing policies, as well as policies and practices established by the Roybal Center for Dementia Caregiving Mastery at Emory University. The data to be collected include common data elements, including the Caregiver Mastery Scale developed by Pearlin and colleagues, as well as demographic characteristics. Although these data will be de-identified prior to release for sharing, there remains a possibility of deductive disclosure of participants with unusual characteristics. Therefore, this data sharing agreement will require: 1) a commitment only to use the data for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroy or return the data after analyses are completed.', 'accessCriteria': 'Researchers must qualify and enter into a data sharing agreement. The agreement requires: 1) a commitment only to use the data for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroy or return the data after analyses are completed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Georgia State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Candace Kemp', 'investigatorAffiliation': 'Georgia State University'}}}}