Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2026-01-02 @ 12:12 AM
Study NCT ID:
NCT01378195
Status:
COMPLETED
Last Update Posted:
2013-02-28
First Post:
2011-06-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
iCare Stress Management e-Training for Dementia Family Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D003704', 'term': 'Dementia'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@photozig.com', 'phone': '650-694-7496', 'title': 'Bruno Kajiyama', 'organization': 'Photozig, Inc.'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'CBT-based', 'description': 'CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website', 'otherNumAtRisk': 75, 'otherNumAffected': 0, 'seriousNumAtRisk': 75, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Educational/Resources Materials', 'description': 'Educational/Resources Materials: video, workbook, and website.', 'otherNumAtRisk': 75, 'otherNumAffected': 0, 'seriousNumAtRisk': 75, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Perceived Stress Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-based', 'description': 'CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website'}, {'id': 'OG001', 'title': 'Educational/Resources Materials', 'description': 'Educational/Resources Materials: video, workbook, and website.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.83', 'spread': '5.07', 'groupId': 'OG000'}, {'value': '16.41', 'spread': '7.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The "Perceived Stress Scale" measures the overall level of stress. This instrument contains 10 items accessing overall appraisals of stress in the past month. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=40. Higher values represent a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Revised Memory and Behavior Problems Checklist', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-based', 'description': 'CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website'}, {'id': 'OG001', 'title': 'Educational/Resources Materials', 'description': 'Educational/Resources Materials: video, workbook, and website.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.83', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '0.91', 'spread': '0.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'This scale measures the type/number of dementia patients disturbing behaviors, and how much they bother caregivers with 24 items describing possible troublesome behaviors that the patient might evidence in the past month. Caregivers are first asked whether the dementia patient had displayed any of these in the time period, and secondly to rate on a 5-point scale (0=not at all; 4= extremely) how much this "bothered or upset" them. A "conditional bother" score is calculated which is the "upset" or "bother" ratings for only the problematic behavior that occurred. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=4. Higher values represent a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Perceived Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-based', 'description': 'CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website'}, {'id': 'OG001', 'title': 'Educational/Resources Materials', 'description': 'Educational/Resources Materials: video, workbook, and website.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.34', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '6.31', 'spread': '1.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The "Perceived Quality of Life" (PQoL instrument) measures quality of life by the evaluation of major categories of fundamental life needs. This measure was developed using a normative sample of older individuals, and has been used in a number of studies investigating the effects of chronic disorders on the perceived quality of life. The scale contains items describing level of satisfaction with needs and resources in various categories. The scale refers to the caregiver. Minimum (worst value) = 0. Maximum score (best value=10. Higher values represent a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CBT-based', 'description': 'CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website'}, {'id': 'FG001', 'title': 'Educational/Resources Materials', 'description': 'Educational/Resources Materials: video, workbook, and website.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '18'}]}]}], 'recruitmentDetails': 'Dates of recruitment period: May 2011 to March 2012', 'preAssignmentDetails': 'Participant assignment to group was random.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CBT-based', 'description': 'CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website'}, {'id': 'BG001', 'title': 'Educational/Resources Materials', 'description': 'Educational/Resources Materials: video, workbook, and website.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-22', 'studyFirstSubmitDate': '2011-06-17', 'resultsFirstSubmitDate': '2012-08-30', 'studyFirstSubmitQcDate': '2011-06-20', 'lastUpdatePostDateStruct': {'date': '2013-02-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-12-05', 'studyFirstPostDateStruct': {'date': '2011-06-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived Stress Scale', 'timeFrame': '3 months', 'description': 'The "Perceived Stress Scale" measures the overall level of stress. This instrument contains 10 items accessing overall appraisals of stress in the past month. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=40. Higher values represent a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Revised Memory and Behavior Problems Checklist', 'timeFrame': '3 months', 'description': 'This scale measures the type/number of dementia patients disturbing behaviors, and how much they bother caregivers with 24 items describing possible troublesome behaviors that the patient might evidence in the past month. Caregivers are first asked whether the dementia patient had displayed any of these in the time period, and secondly to rate on a 5-point scale (0=not at all; 4= extremely) how much this "bothered or upset" them. A "conditional bother" score is calculated which is the "upset" or "bother" ratings for only the problematic behavior that occurred. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=4. Higher values represent a worse outcome.'}, {'measure': 'Perceived Quality of Life', 'timeFrame': '3 months', 'description': 'The "Perceived Quality of Life" (PQoL instrument) measures quality of life by the evaluation of major categories of fundamental life needs. This measure was developed using a normative sample of older individuals, and has been used in a number of studies investigating the effects of chronic disorders on the perceived quality of life. The scale contains items describing level of satisfaction with needs and resources in various categories. The scale refers to the caregiver. Minimum (worst value) = 0. Maximum score (best value=10. Higher values represent a better outcome.'}]}, 'conditionsModule': {'keywords': ["Alzheimer's Disease", 'Dementia', 'caregiving', 'caregiver', 'coping', 'coping with caregiving', 'stress'], 'conditions': ["Alzheimer's Disease", 'Dementia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.icarefamily.com', 'label': 'Dementia Caregiving Program'}]}, 'descriptionModule': {'briefSummary': 'Photozig and Stanford University are creating a program to help cope with caregiving, alleviate related stress, and enhance quality of life for caregivers, with funding from the National Institute on Aging. This home-based program includes a free DVD, printed materials, and resource website. In addition, after completing the program, participants will have free access to final online resources for 1 year. There are no face-to-face meetings, and participants can live anywhere in the United States.', 'detailedDescription': "The goal of this study is to develop the iCare Program, a DVD/online video training that builds skills and stimulates practice. We are evaluating different materials, which may encourage caregiver participation, enable user interaction, and promote better assimilation of concepts. We are designing the program to help to enhance caregivers' skills to deal with demanding tasks of caregiving, alleviate related stress, and improve quality of life.\n\nResearch Program Steps:\n\n1. Caregivers will be asked some simple questions about themselves and their family members to see if they are eligible for the project (fill out Enrollment Form and Informed Consent).\n2. A Program survey will be sent, which can be completed online, or returned in a pre-mailed envelope.\n3. A DVD, materials, link to our website, login information, and instructions will be mailed to participants. We ask participants to watch the DVD, read printed materials, use the website, and follow instructions. Materials are expected to help participants in their caregiver role.\n4. After completing the program, the second and final survey should be filled out online or returned by pre-mailed envelope."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Care for an individual with Alzheimer's Disease or other dementia.\n* Own a DVD player or have Internet access.\n* Minimum age of 21 years old.\n* Spend at least 8 hours/week caring for a person with dementia, which may include assisting, watching, monitoring, or being available to help (e.g. during sleep time).\n\nExclusion Criteria:\n\n* Severe psychological or physical illness.\n* Inability to read and follow English instructions.\n* High level of depressive symptoms.\n* Unwillingness to participate in all aspects of the study."}, 'identificationModule': {'nctId': 'NCT01378195', 'acronym': 'iCare', 'briefTitle': 'iCare Stress Management e-Training for Dementia Family Caregivers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Photozig, Inc.'}, 'officialTitle': 'iCare Stress Management e-Training for Dementia Family Caregivers', 'orgStudyIdInfo': {'id': 'Pz-A103a'}, 'secondaryIdInfos': [{'id': 'R44AG032762', 'link': 'https://reporter.nih.gov/quickSearch/R44AG032762', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBT-based', 'description': 'CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website', 'interventionNames': ['Behavioral: CBT-based program for dementia caregivers']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Educational/Resources Materials', 'description': 'Educational/Resources Materials: video, workbook, and website.', 'interventionNames': ['Behavioral: Educational/Resources program']}], 'interventions': [{'name': 'CBT-based program for dementia caregivers', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a CBT-based program \\[Cognitive Behavioral Therapy\\], containing videos, workbook, and website.', 'armGroupLabels': ['CBT-based']}, {'name': 'Educational/Resources program', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a traditional educational/resources program, containing videos, workbook, and website.', 'armGroupLabels': ['Educational/Resources Materials']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94035-0128', 'city': 'Moffett Field', 'state': 'California', 'country': 'United States', 'facility': 'Photozig, Inc.'}], 'overallOfficials': [{'name': 'Bruno Kajiyama, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Photozig, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Photozig, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Stanford University', 'class': 'OTHER'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}