Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-03-03 @ 12:34 AM
Study NCT ID:
NCT02667951
Status:
COMPLETED
Last Update Posted:
2023-08-30
First Post:
2016-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Home-based Training Program for Elderly Patients With Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yeaing@mail.cgu.edu.tw', 'phone': '+886-3-211 8800', 'title': 'Dr. Yea-Ing L. Shyu', 'phoneExt': '5275', 'organization': 'School of Nursing, College of Medicine, Chang Gung University, Taoyuan, Taiwan'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control Group', 'description': 'Caregivers received general information on dementia care and follow-up phone calls simply to maintain contact, but without any training for developing a behavioral problem-management plan and strategies.', 'otherNumAtRisk': 66, 'otherNumAffected': 0, 'seriousNumAtRisk': 66, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intervention Group', 'description': 'Caregivers received solutions for managing behavioral problems, with referrals to community services and telephone consultation, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.\n\nA home-based caregiver-training program: A home-based caregiver-training program consisted of two weekly sessions, each lasting 2 to 3 hours. Following the training sessions, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.', 'otherNumAtRisk': 63, 'otherNumAffected': 0, 'seriousNumAtRisk': 63, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Caregivers' Self-efficacy", 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Caregivers received general information on dementia care and follow-up phone calls simply to maintain contact, but without any training for developing a behavioral problem-management plan and strategies.'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': 'Caregivers received solutions for managing behavioral problems, with referrals to community services and telephone consultation, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.\n\nA home-based caregiver-training program: A home-based caregiver-training program consisted of two weekly sessions, each lasting 2 to 3 hours. Following the training sessions, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.'}], 'classes': [{'categories': [{'measurements': [{'value': '155', 'spread': '34', 'groupId': 'OG000'}, {'value': '178', 'spread': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': "The Agitation Management Self-efficacy Scale was used to measure caregivers' self-efficacy for managing dementia patients' agitation. Caregivers were asked how confident they were about handling the problem for each identified behavioral problem and if they believed that they could manage the problem for behaviors that did not occur. Scores range from 42 to 210, with higher scores representing greater caregiver self-efficacy. In this study, Cronbach's alphas ranged from 0.98 to 0.99 at different time points.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Caregivers' Preparedness", 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Caregivers received general information on dementia care and follow-up phone calls simply to maintain contact, but without any training for developing a behavioral problem-management plan and strategies.'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': 'Caregivers received solutions for managing behavioral problems, with referrals to community services and telephone consultation, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.\n\nA home-based caregiver-training program: A home-based caregiver-training program consisted of two weekly sessions, each lasting 2 to 3 hours. Following the training sessions, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'spread': '8', 'groupId': 'OG000'}, {'value': '38', 'spread': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': "Preparedness was measured by the 10-item Caregiver Preparedness Scale,asks caregivers to rate how well prepared they think they are for seven domains of caregiving. A final question asks for an overall rating of how well prepared caregivers think they are to care for the care receiver. Items are scored on a 5-point Likert scale from 1 (not prepared) to 5 (well prepared). Scores range from 10 to 50, with higher scores representing greater preparedness for caregiving tasks. Validity and reliability of the original Preparedness scale was supported.24 The content validity index for the Preparedness Scale Taiwanese version was 1.0 and Cronbach's alpha for this scale among Taiwanese caregivers was 0.87. Cronbach's alpha in this study was 0.92.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Caregivers' Competence", 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Caregivers received general information on dementia care and follow-up phone calls simply to maintain contact, but without any training for developing a behavioral problem-management plan and strategies.'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': 'Caregivers received solutions for managing behavioral problems, with referrals to community services and telephone consultation, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.\n\nA home-based caregiver-training program: A home-based caregiver-training program consisted of two weekly sessions, each lasting 2 to 3 hours. Following the training sessions, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'spread': '13', 'groupId': 'OG000'}, {'value': '66', 'spread': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': "A 17-item Competence Scale was used to assess caregivers' knowledge and skills for managing behavioral problems of patients with dementia. Scores range from 17 to 85, with higher scores representing better competence. In this study, Cronbach's alpha ranged from 0.90 to 0.93 at different time points.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Dementia Patients' Behavioral Problems", 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Caregivers received general information on dementia care and follow-up phone calls simply to maintain contact, but without any training for developing a behavioral problem-management plan and strategies.'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': 'Caregivers received solutions for managing behavioral problems, with referrals to community services and telephone consultation, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.\n\nA home-based caregiver-training program: A home-based caregiver-training program consisted of two weekly sessions, each lasting 2 to 3 hours. Following the training sessions, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.89', 'spread': '1.66', 'groupId': 'OG000'}, {'value': '7.88', 'spread': '1.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': "Physically aggressive behaviors of dementia patients were measured by the PAB subscale of the Chinese version CMAI, community form, which was shown to be valid and reliable for a Taiwanese sample. Each item (behavioral problem) is scored according to its frequency from 1 (never happens) to 7 (several times per hour). PAB subscale scores range from 7 to 49, with higher scores indicating more physically aggressive behaviors. In this study, the PAB subscale had Cronbach's alpha of 0.55.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Caregivers' Quality of Life", 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Caregivers received general information on dementia care and follow-up phone calls simply to maintain contact, but without any training for developing a behavioral problem-management plan and strategies.'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': 'Caregivers received solutions for managing behavioral problems, with referrals to community services and telephone consultation, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.\n\nA home-based caregiver-training program: A home-based caregiver-training program consisted of two weekly sessions, each lasting 2 to 3 hours. Following the training sessions, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.'}], 'classes': [{'title': 'PF', 'categories': [{'measurements': [{'value': '80.22', 'spread': '23.48', 'groupId': 'OG000'}, {'value': '83.38', 'spread': '26.00', 'groupId': 'OG001'}]}]}, {'title': 'RP', 'categories': [{'measurements': [{'value': '67.22', 'spread': '47.02', 'groupId': 'OG000'}, {'value': '73.13', 'spread': '43.63', 'groupId': 'OG001'}]}]}, {'title': 'RE', 'categories': [{'measurements': [{'value': '70.37', 'spread': '45.07', 'groupId': 'OG000'}, {'value': '88.33', 'spread': '29.77', 'groupId': 'OG001'}]}]}, {'title': 'SF', 'categories': [{'measurements': [{'value': '68.06', 'spread': '28.27', 'groupId': 'OG000'}, {'value': '87.50', 'spread': '17.68', 'groupId': 'OG001'}]}]}, {'title': 'BP', 'categories': [{'measurements': [{'value': '72.84', 'spread': '25.09', 'groupId': 'OG000'}, {'value': '82.25', 'spread': '18.75', 'groupId': 'OG001'}]}]}, {'title': 'VT', 'categories': [{'measurements': [{'value': '52.00', 'spread': '21.52', 'groupId': 'OG000'}, {'value': '69.75', 'spread': '13.77', 'groupId': 'OG001'}]}]}, {'title': 'MH', 'categories': [{'measurements': [{'value': '64.09', 'spread': '21.65', 'groupId': 'OG000'}, {'value': '72.50', 'spread': '13.07', 'groupId': 'OG001'}]}]}, {'title': 'GH', 'categories': [{'measurements': [{'value': '50.64', 'spread': '27.43', 'groupId': 'OG000'}, {'value': '63.75', 'spread': '22.22', 'groupId': 'OG001'}]}]}, {'title': 'PCS', 'categories': [{'measurements': [{'value': '51.39', 'spread': '9.72', 'groupId': 'OG000'}, {'value': '52.96', 'spread': '10.64', 'groupId': 'OG001'}]}]}, {'title': 'MCS', 'categories': [{'measurements': [{'value': '50.10', 'spread': '10.92', 'groupId': 'OG000'}, {'value': '57.85', 'spread': '7.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': "The Taiwan version of the Medical Outcomes SF-36 was used to measure family caregivers' HRQoL. The SF-36 contains eight generic health concepts: physical functioning (PF), role disability due to physical health problems (RP); bodily pain (BP); vitality (energy/fatigue) (VT); general health perceptions (GH); role disability due to emotional problems (RE); social functioning (SF); and general mental health (MH). Taiwan-specific SF-36 algorithms were used to compute the Mental Component Summary (MCS) and Physical Component Summary (PCS) scores using norm-based (mean = 50, SD = 10) scoring methods. Scores for each scale range from 0 to 100, with higher scores representing better health outcomes. In this study, Cronbach's alphas for the eight scales ranged from 0.81 to 0.99.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Caregivers' Depressive Symptoms", 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Caregivers received general information on dementia care and follow-up phone calls simply to maintain contact, but without any training for developing a behavioral problem-management plan and strategies.'}, {'id': 'OG001', 'title': 'Intervention Group', 'description': 'Caregivers received solutions for managing behavioral problems, with referrals to community services and telephone consultation, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.\n\nA home-based caregiver-training program: A home-based caregiver-training program consisted of two weekly sessions, each lasting 2 to 3 hours. Following the training sessions, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'spread': '12', 'groupId': 'OG000'}, {'value': '8', 'spread': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': "A 17-item Competence Scale was used to assess caregivers' knowledge and skills for managing behavioral problems of patients with dementia. Scores range from 17 to 85, with higher scores representing better competence. In this study, Cronbach's alpha ranged from 0.90 to 0.93 at different time points.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group', 'description': 'Caregivers received general information on dementia care and follow-up phone calls simply to maintain contact, but without any training for developing a behavioral problem-management plan and strategies.'}, {'id': 'FG001', 'title': 'Intervention Group', 'description': 'Caregivers received solutions for managing behavioral problems, with referrals to community services and telephone consultation, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.\n\nA home-based caregiver-training program: A home-based caregiver-training program consisted of two weekly sessions, each lasting 2 to 3 hours. Following the training sessions, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '23'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group', 'description': 'Caregivers received general information on dementia care and follow-up phone calls simply to maintain contact, but without any training for developing a behavioral problem-management plan and strategies.'}, {'id': 'BG001', 'title': 'Intervention Group', 'description': 'Caregivers received solutions for managing behavioral problems, with referrals to community services and telephone consultation, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.\n\nA home-based caregiver-training program: A home-based caregiver-training program consisted of two weekly sessions, each lasting 2 to 3 hours. Following the training sessions, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}], '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': '48', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '56', 'spread': '12', 'groupId': 'BG000'}, {'value': '55', 'spread': '15', 'groupId': 'BG001'}, {'value': '55', 'spread': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'year', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-28', 'studyFirstSubmitDate': '2016-01-23', 'resultsFirstSubmitDate': '2017-02-02', 'studyFirstSubmitQcDate': '2016-01-28', 'lastUpdatePostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-02', 'studyFirstPostDateStruct': {'date': '2016-01-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Caregivers' Self-efficacy", 'timeFrame': '18 months', 'description': "The Agitation Management Self-efficacy Scale was used to measure caregivers' self-efficacy for managing dementia patients' agitation. Caregivers were asked how confident they were about handling the problem for each identified behavioral problem and if they believed that they could manage the problem for behaviors that did not occur. Scores range from 42 to 210, with higher scores representing greater caregiver self-efficacy. In this study, Cronbach's alphas ranged from 0.98 to 0.99 at different time points."}, {'measure': "Caregivers' Preparedness", 'timeFrame': '18 months', 'description': "Preparedness was measured by the 10-item Caregiver Preparedness Scale,asks caregivers to rate how well prepared they think they are for seven domains of caregiving. A final question asks for an overall rating of how well prepared caregivers think they are to care for the care receiver. Items are scored on a 5-point Likert scale from 1 (not prepared) to 5 (well prepared). Scores range from 10 to 50, with higher scores representing greater preparedness for caregiving tasks. Validity and reliability of the original Preparedness scale was supported.24 The content validity index for the Preparedness Scale Taiwanese version was 1.0 and Cronbach's alpha for this scale among Taiwanese caregivers was 0.87. Cronbach's alpha in this study was 0.92."}, {'measure': "Caregivers' Competence", 'timeFrame': '18 months', 'description': "A 17-item Competence Scale was used to assess caregivers' knowledge and skills for managing behavioral problems of patients with dementia. Scores range from 17 to 85, with higher scores representing better competence. In this study, Cronbach's alpha ranged from 0.90 to 0.93 at different time points."}, {'measure': "Dementia Patients' Behavioral Problems", 'timeFrame': '18 months', 'description': "Physically aggressive behaviors of dementia patients were measured by the PAB subscale of the Chinese version CMAI, community form, which was shown to be valid and reliable for a Taiwanese sample. Each item (behavioral problem) is scored according to its frequency from 1 (never happens) to 7 (several times per hour). PAB subscale scores range from 7 to 49, with higher scores indicating more physically aggressive behaviors. In this study, the PAB subscale had Cronbach's alpha of 0.55."}], 'secondaryOutcomes': [{'measure': "Caregivers' Quality of Life", 'timeFrame': '18 months', 'description': "The Taiwan version of the Medical Outcomes SF-36 was used to measure family caregivers' HRQoL. The SF-36 contains eight generic health concepts: physical functioning (PF), role disability due to physical health problems (RP); bodily pain (BP); vitality (energy/fatigue) (VT); general health perceptions (GH); role disability due to emotional problems (RE); social functioning (SF); and general mental health (MH). Taiwan-specific SF-36 algorithms were used to compute the Mental Component Summary (MCS) and Physical Component Summary (PCS) scores using norm-based (mean = 50, SD = 10) scoring methods. Scores for each scale range from 0 to 100, with higher scores representing better health outcomes. In this study, Cronbach's alphas for the eight scales ranged from 0.81 to 0.99."}, {'measure': "Caregivers' Depressive Symptoms", 'timeFrame': '18 months', 'description': "A 17-item Competence Scale was used to assess caregivers' knowledge and skills for managing behavioral problems of patients with dementia. Scores range from 17 to 85, with higher scores representing better competence. In this study, Cronbach's alpha ranged from 0.90 to 0.93 at different time points."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Elderly', 'Dementia', 'Intervention program'], 'conditions': ['Dementia']}, 'referencesModule': {'references': [{'pmid': '27720499', 'type': 'DERIVED', 'citation': 'Kuo LM, Huang HL, Liang J, Kwok YT, Hsu WC, Liu CY, Shyu YL. Trajectories of health-related quality of life among family caregivers of individuals with dementia: A home-based caregiver-training program matters. Geriatr Nurs. 2017 Mar-Apr;38(2):124-132. doi: 10.1016/j.gerinurse.2016.08.017. Epub 2016 Oct 6.'}, {'pmid': '27653753', 'type': 'DERIVED', 'citation': 'Kuo LM, Huang HL, Liang J, Kwok YT, Hsu WC, Su PL, Shyu YL. A randomized controlled trial of a home-based training programme to decrease depression in family caregivers of persons with dementia. J Adv Nurs. 2017 Mar;73(3):585-598. doi: 10.1111/jan.13157. Epub 2016 Oct 17.'}]}, 'descriptionModule': {'briefSummary': "The illness course and symptoms of dementia is usually very long and characterized with behavioral, psychological and physical changes. Family caregivers' stresses change during the illness trajectory as well. The purpose of this study is to compare the costs and effectiveness of two care models- home-based caregiver-training program model and routine care model for dementia elders in Taiwan.", 'detailedDescription': "The illness course and symptoms of dementia is usually very long and characterized with behavioral, psychological and physical changes. Family caregivers' stresses change during the illness trajectory as well. Thus, the needs of the elderly persons with dementia and their family caregivers differ in different stage of dementia, and the services they require are multidimensional. According to the researchers' previous 2-year study, behavioral problem management and service utilization were found to be the most difficult and least prepared caregiving activities and the family caregiver's needs for assistance of these two caregiving activities differed in different stage of dementia.The purpose of this study is to compare the costs and effectiveness of two care models- home-based caregiver-training program model and routine care model for dementia elders in Taiwan."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:(patients)\n\n* diagnosed with dementia by a psychiatrist or neurologist\n* Age 65 years or older\n* living in a community of northern Taiwan\n* living in a home setting\n* scored \\>50 on the Chinese version Cohen-Mansfield Agitation Inventory (CMAI).\n\nExclusion Criteria:(patients)\n\n* diagnosed with critical illness.\n\nInclusion Criteria:(caregivers)\n\n* Primary caregiving responsibility and be at least 20 years old.\n\nExclusion Criteria:(caregivers)\n\n* diagnosed with critical illness.'}, 'identificationModule': {'nctId': 'NCT02667951', 'briefTitle': 'A Home-based Training Program for Elderly Patients With Dementia', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Establishment and Effectiveness of a Community-based Long-term Care Model for Elderly Persons With Dementia', 'orgStudyIdInfo': {'id': 'NSC 97-2420-H-182-002-MY3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Caregivers received general information on dementia care and follow-up phone calls simply to maintain contact, but without any training for developing a behavioral problem-management plan and strategies.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Caregivers received solutions for managing behavioral problems, with referrals to community services and telephone consultation, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.', 'interventionNames': ['Other: A home-based caregiver-training program']}], 'interventions': [{'name': 'A home-based caregiver-training program', 'type': 'OTHER', 'description': 'A home-based caregiver-training program consisted of two weekly sessions, each lasting 2 to 3 hours. Following the training sessions, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Yea-Ing L Shyu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Science and Technology Council, Taiwan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yea-Ing Lotus Shyu', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}