Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-28 @ 1:32 AM
Study NCT ID:
NCT04428034
Status:
COMPLETED
Last Update Posted:
2023-03-21
First Post:
2020-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Learning Skills Together Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'meyerk1@uthscsa.edu', 'phone': '210-450-5386', 'title': 'Kylie Meyer, PhD', 'organization': 'UT Health San Antonio'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Application of a. pre- and post-test design means that changes in self-efficacy cannot be attributed to the intervention alone\n\nResults from this study are subject to selection bias given participant dropout between survey collection times\n\nThe small size of the analytic sample may have contributed to Type II error for some outcomes'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected over 1 year.', 'eventGroups': [{'id': 'EG000', 'title': 'Learning Skills Together Intervention', 'description': "Participants in the Learning Skills Together program will begin their participation with a one-on-one phone call with an interventionist, who will ensure the participant is prepared to to attend the group sessions (e.g., familiar with videoconference technology) and will help the participant to set individual goals. The caregiver participant will then attend 4, group-based sessions lasting approximately 1.5 hours each, to learn about common complex care tasks managed by family caregivers to someone with mid-stage Alzheimer's disease, such as managing behavioral symptoms of dementia, incontinence, nutrition, transferring, medication management, and more. Sessions will integrate interactive activities, such as videos, case studies, and discussions. Approximately four weeks later, caregivers will be asked to attend a group reflection session to discuss application of what was learned and progress in meeting individual goals.\n\nLearning Skills Together: Information provided in arm/group description.", 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 3, 'seriousNumAtRisk': 35, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Adverse Event: Identification of Severe Depression', 'notes': 'This event pertains to caregivers who were identified during any measurement occasion as having severe depression. It is not known whether high depression scores were related to study participation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Caregiver Competency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Learning Skills Together Intervention', 'description': "Participants in the Learning Skills Together program will begin their participation with a one-on-one phone call with an interventionist, who will ensure the participant is prepared to to attend the group sessions (e.g., familiar with videoconference technology) and will help the participant to set individual goals. The caregiver participant will then attend 4, group-based sessions lasting approximately 1.5 hours each, to learn about common complex care tasks managed by family caregivers to someone with mid-stage Alzheimer's disease, such as managing behavioral symptoms of dementia, incontinence, nutrition, transferring, medication management, and more. Sessions will integrate interactive activities, such as videos, case studies, and discussions. Approximately four weeks later, caregivers will be asked to attend a group reflection session to discuss application of what was learned and progress in meeting individual goals.\n\nLearning Skills Together: Information provided in arm/group description."}], 'classes': [{'title': '4-Weeks Post-Intervention', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.6', 'groupId': 'OG000'}]}]}, {'title': '8-Weeks Post-Intervention', 'categories': [{'measurements': [{'value': '1.0', 'spread': '2.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to 4 weeks post-intervention; and to 8 weeks post-intervention', 'description': 'This will be measured using the Caregiving Competence Scale. This measure includes 3-items pertaining to caregiver\'s confidence (e.g., "I feel confident that I am meeting the needs of my relative"). There are five response options to each statement ("Strongly Disagree" \\[1\\] to "Strongly Agree" \\[5\\]), such that scores may range from 3 to 15. A lower score indicates a lower level of confidence that the caregiver is meeting their relative\'s needs (i.e., higher scores are better). The outcome measure will use the average change score from baseline scores.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Caregiver Mastery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Learning Skills Together Intervention', 'description': "Participants in the Learning Skills Together program will begin their participation with a one-on-one phone call with an interventionist, who will ensure the participant is prepared to to attend the group sessions (e.g., familiar with videoconference technology) and will help the participant to set individual goals. The caregiver participant will then attend 4, group-based sessions lasting approximately 1.5 hours each, to learn about common complex care tasks managed by family caregivers to someone with mid-stage Alzheimer's disease, such as managing behavioral symptoms of dementia, incontinence, nutrition, transferring, medication management, and more. Sessions will integrate interactive activities, such as videos, case studies, and discussions. Approximately four weeks later, caregivers will be asked to attend a group reflection session to discuss application of what was learned and progress in meeting individual goals.\n\nLearning Skills Together: Information provided in arm/group description."}], 'classes': [{'title': '4-Weeks Post-Intervention', 'categories': [{'measurements': [{'value': '0.7', 'spread': '2.3', 'groupId': 'OG000'}]}]}, {'title': '8-Weeks Post-Intervention', 'categories': [{'measurements': [{'value': '0.5', 'spread': '2.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to 4 weeks post-intervention; and to 8 weeks post-intervention', 'description': 'This will be measured using the Caregiver Mastery Scale. This 7-item scale asks participants the extent to which they feel they have control over various parts of their lives (e.g., "I have little control over the things that happen to me"). Participants may respond that they "Strongly Disagree (1) to Strongly agree (4) with each statement, such that scores range from 7 to 28. The lower the score, the less control the caregiver feels that they have control (i.e., higher scores are better). The mean score for this measure among caregivers to frail older adults was previously reported as 19.42 (SD 3.29), with Cronbach\'s alpha of 0.78. The outcome measure will use the average change score from baseline scores.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Learning Skills Together Intervention', 'description': "Participants in the Learning Skills Together program will begin their participation with a one-on-one phone call with an interventionist, who will ensure the participant is prepared to to attend the group sessions (e.g., familiar with videoconference technology) and will help the participant to set individual goals. The caregiver participant will then attend 4, group-based sessions lasting approximately 1.5 hours each, to learn about common complex care tasks managed by family caregivers to someone with mid-stage Alzheimer's disease, such as managing behavioral symptoms of dementia, incontinence, nutrition, transferring, medication management, and more. Sessions will integrate interactive activities, such as videos, case studies, and discussions. Approximately four weeks later, caregivers will be asked to attend a group reflection session to discuss application of what was learned and progress in meeting individual goals.\n\nLearning Skills Together: Information provided in arm/group description."}], 'periods': [{'title': 'Enrollment to Intervention Completion', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'Attended at Least 2 Intervention Sessions in One Cohort', 'achievements': [{'comment': 'Forty-one (41) participants enrolled and completed the baseline survey. Of those who completed the baseline survey, three participants did not attend at least two sessions. Three participants started the intervention in one cohort but completed it in another (off-protocol).', 'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}, {'title': '4-Week Follow Up Survey', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}, {'title': '8-Week Follow Up Survey', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Of those 27 who completed the 8-week follow up survey, one participant skipped the 4-week follow up survey but completed the 8-week survey.', 'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Learning Skills Together Intervention', 'description': "Participants in the Learning Skills Together program will begin their participation with a one-on-one phone call with an interventionist, who will ensure the participant is prepared to to attend the group sessions (e.g., familiar with videoconference technology) and will help the participant to set individual goals. The caregiver participant will then attend 4, group-based sessions lasting approximately 1.5 hours each, to learn about common complex care tasks managed by family caregivers to someone with mid-stage Alzheimer's disease, such as managing behavioral symptoms of dementia, incontinence, nutrition, transferring, medication management, and more. Sessions will integrate interactive activities, such as videos, case studies, and discussions. Approximately four weeks later, caregivers will be asked to attend a group reflection session to discuss application of what was learned and progress in meeting individual goals.\n\nLearning Skills Together: Information provided in arm/group description."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race and Ethnicity', 'categories': [{'title': 'African American/Black', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Caucasian/white', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Hispanic', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Caregiver Competency', 'classes': [{'categories': [{'measurements': [{'value': '11.6', 'spread': '2.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "Measured using the Caregiver Competency Scale, a 3 item scale. Each scale has 5 responses: Never (0), to All of the time (5). Scores range from 3-15 with a lower score indicating less confidence in providing for relative's needs.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Caregiver Mastery', 'classes': [{'categories': [{'measurements': [{'value': '16.6', 'spread': '2.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Measured using the Caregiver Mastery Scale, a 7 item scale which asks the participant the extent to which they feel they have control over various parts of their lives. Responses range from Strongly Disagree (1) to Strongly Agree (4). Range of scores are from 7-28, with a lower score showing that the caregiver believes they have less control.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Baseline characteristics are described for the analysis population, which includes participants who were eligible according to initial criteria, but who also: 1) attended at least 2 program sessions and 2) completed the program in the same cohort (i.e., did not start in one cohort and complete "make up" sessions in the following cohort.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-03', 'size': 533378, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-20T11:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A pre- and post-test design to test the Learning Skills Together program will be employed.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-17', 'studyFirstSubmitDate': '2020-06-09', 'resultsFirstSubmitDate': '2021-08-30', 'studyFirstSubmitQcDate': '2020-06-10', 'lastUpdatePostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-13', 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Caregiver Competency', 'timeFrame': 'Change from baseline to 4 weeks post-intervention; and to 8 weeks post-intervention', 'description': 'This will be measured using the Caregiving Competence Scale. This measure includes 3-items pertaining to caregiver\'s confidence (e.g., "I feel confident that I am meeting the needs of my relative"). There are five response options to each statement ("Strongly Disagree" \\[1\\] to "Strongly Agree" \\[5\\]), such that scores may range from 3 to 15. A lower score indicates a lower level of confidence that the caregiver is meeting their relative\'s needs (i.e., higher scores are better). The outcome measure will use the average change score from baseline scores.'}, {'measure': 'Change in Caregiver Mastery', 'timeFrame': 'Change from baseline to 4 weeks post-intervention; and to 8 weeks post-intervention', 'description': 'This will be measured using the Caregiver Mastery Scale. This 7-item scale asks participants the extent to which they feel they have control over various parts of their lives (e.g., "I have little control over the things that happen to me"). Participants may respond that they "Strongly Disagree (1) to Strongly agree (4) with each statement, such that scores range from 7 to 28. The lower the score, the less control the caregiver feels that they have control (i.e., higher scores are better). The mean score for this measure among caregivers to frail older adults was previously reported as 19.42 (SD 3.29), with Cronbach\'s alpha of 0.78. The outcome measure will use the average change score from baseline scores.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Family Caregiving', 'Complex Care', 'Self Efficacy', 'Intervention']}, 'referencesModule': {'references': [{'pmid': '649936', 'type': 'BACKGROUND', 'citation': 'Pearlin LI, Schooler C. The structure of coping. J Health Soc Behav. 1978 Mar;19(1):2-21. No abstract available.'}, {'pmid': '2276631', 'type': 'BACKGROUND', 'citation': 'Pearlin LI, Mullan JT, Semple SJ, Skaff MM. Caregiving and the stress process: an overview of concepts and their measures. Gerontologist. 1990 Oct;30(5):583-94. doi: 10.1093/geront/30.5.583.'}, {'pmid': '30498832', 'type': 'BACKGROUND', 'citation': 'Chan EY, Glass G, Chua KC, Ali N, Lim WS. Relationship between Mastery and Caregiving Competence in Protecting against Burden, Anxiety and Depression among Caregivers of Frail Older Adults. J Nutr Health Aging. 2018;22(10):1238-1245. doi: 10.1007/s12603-018-1098-1.'}, {'type': 'BACKGROUND', 'citation': "Robertson, SM, Zarit, SH, Duncan, LG, Rovine, MJ, & Femia, EE. Family caregivers' patterns of positive and negative affect. Family Relations. 2007; 56(1): 12-23."}]}, 'descriptionModule': {'briefSummary': "The Learning Skills Together (LST) program is a synchronous web-based educational intervention developed to address the essential need for training to equip family caregivers to someone with mid-stage Alzheimer's disease to confidently provide complex care tasks.The purpose of this pilot study is to evaluate the feasibility of delivering LST, the program's acceptability to caregivers, and likelihood of effecting caregivers self-efficacy and mastery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'All genders are eligible. Gender is self-reported. Participants may select "Male," "Female," and "Other" gender, and may select all responses that apply.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Family member (including families of choice) to an individual living with Alzheimer's disease who has received a diagnosis from a physician\n* Ages 18 and old\n* Provides assistance with at least two instrumental activities of daily living or one activity of daily living\n* Care recipient is described as being within mid-stage Alzheimer's Disease\n* There are no plans to place the care recipient in a skilled nursing facility within the next 3 months\n\nExclusion Criteria:\n\n* The caregiver is paid to provide care\n* The caregiver does not have reliable access to a computer and internet\n* The caregiver is unable to read and speak English"}, 'identificationModule': {'nctId': 'NCT04428034', 'briefTitle': 'Learning Skills Together Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': "A Pilot Evaluation of Learning Skills Together: A Intervention to Teach Complex Care Skills to Caregivers of Persons Living With Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'HSC20200410H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Learning Skills Together Intervention', 'description': "Participants in the Learning Skills Together program will begin their participation with a one-on-one phone call with an interventionist, who will ensure the participant is prepared to to attend the group sessions (e.g., familiar with videoconference technology) and will help the participant to set individual goals. The caregiver participant will then attend 4, group-based sessions lasting approximately 1.5 hours each, to learn about common complex care tasks managed by family caregivers to someone with mid-stage Alzheimer's disease, such as managing behavioral symptoms of dementia, incontinence, nutrition, transferring, medication management, and more. Sessions will integrate interactive activities, such as videos, case studies, and discussions. Approximately four weeks later, caregivers will be asked to attend a group reflection session to discuss application of what was learned and progress in meeting individual goals.", 'interventionNames': ['Behavioral: Learning Skills Together']}], 'interventions': [{'name': 'Learning Skills Together', 'type': 'BEHAVIORAL', 'description': 'Information provided in arm/group description.', 'armGroupLabels': ['Learning Skills Together Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Health San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Carole L White, PhD, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UT Health San Antonio'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'De-identified study data will be made available to other researchers if requested.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}