Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-09 @ 9:27 PM
Study NCT ID:
NCT06532305
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-06
First Post:
2024-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Helping Overcome Pressure and Exhaustion: Empowerment Classes for Southeast Asian Migrant Care Workers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077062', 'term': 'Burnout, Psychological'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D000079102', 'term': 'Empowerment'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-26', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-07-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-04', 'studyFirstSubmitDate': '2024-07-29', 'studyFirstSubmitQcDate': '2024-07-29', 'lastUpdatePostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Burnout levels', 'timeFrame': '12 months', 'description': 'Measured using the Copenhagen Burnout Inventory (CBI). The primary outcome will be the change in burnout levels from baseline to the end of each intervention period. Burnout will be assessed in three domains: personal burnout, work-related burnout, and client-related burnout. Higher scores on the CBI indicate a higher level of burnout, meaning worse outcomes in terms of burnout severity. The range of CBI is 0-100.'}, {'measure': 'Emotional Stress', 'timeFrame': '12 months', 'description': 'Measured using the Patient Health Questionnaire-2 (PHQ-2). The outcome will be the change in emotional stress levels from baseline to the end of each intervention period. A PHQ-2 score ranges from 0-6. Higher scores on the PHQ-2 indicate greater severity of depressive symptoms, meaning worse outcomes in terms of emotional stress.'}, {'measure': 'Heart Rate Variability', 'timeFrame': '12 months', 'description': 'Heart Rate Variability measurements will be used to assess changes in autonomic nervous system function, providing an objective measure of stress levels.'}], 'secondaryOutcomes': [{'measure': 'Cultural Adaptation', 'timeFrame': '12 months', 'description': "Measured using the Life and Cultural Adaptation Questionnaire. The secondary outcome will be the change in cultural adaptation levels from baseline to the end of each intervention period. There is a total of 11 questions that inquire about the respondent's adaptation to daily life, work, and culture in Taiwan. Its total score ranges from 11-66. Each item is rated on a scale of 1 to 6, with higher scores indicating better adaptation."}, {'measure': 'Language Proficiency', 'timeFrame': '12 months', 'description': 'Assessed using the Language Proficiency Questionnaire. The secondary outcome will be the change in language proficiency levels from baseline to the end of each intervention period. There is a total of 7 questions primarily aimed at understanding the current usage of Mandarin and Taiwanese. Each item is rated on a scale of 1 to 6, with higher scores indicating better communication skills in the respective language. The total score ranges from 7 to 42.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['empowerment', 'burnout', 'dementia', 'migrant care worker'], 'conditions': ['Heart Rate Variability', 'Burnout', 'Depression']}, 'descriptionModule': {'briefSummary': "As Taiwan's population ages, Southeast Asian migrant care workers are widely employed to fill the care labor gap. These workers often face symptoms of burnout and emotional stress due to long working hours and high-pressure environments. This study aims to evaluate the effects of empowerment classes on reducing burnout symptoms and emotional stress among Southeast Asian migrant care workers. The empowerment classes are designed based on expert consensus and cover three core areas: mental health and stress management, dementia care skills, and language and communication skills. The curriculum is tailored to the practical needs and cultural backgrounds of the migrant workers. A total of 120 Indonesian care workers will be randomly assigned to two groups. The first group will undergo a three-month empowerment course, while the second group will initially participate in social gatherings. Afterward, the groups will switch interventions. The study will last for 12 months, and each participant will complete seven assessments, including heart rate variability measurements and online questionnaires. The questionnaires will include the Patient Health Questionnaire-2 (PHQ-2), the Copenhagen Burnout Inventory (CBI), the Life and Cultural Adaptation Questionnaire, and the Language Proficiency Questionnaire. The study anticipates that the empowerment classes will reduce burnout symptoms and emotional stress, while enhancing cultural adaptation and language proficiency among migrant care workers.", 'detailedDescription': "Study Design:\n\nThe study employs a randomized crossover design involving 120 Indonesian care workers in Taiwan. Participants will be randomly assigned to two groups. The first group will undergo a three-month empowerment course initially, while the second group will participate in social gatherings. After three months, the interventions will be switched between the groups. The empowerment classes will cover three core areas: mental health and stress management, dementia care skills, and language and communication skills, tailored to the workers' practical needs and cultural backgrounds.\n\nDuration:\n\nThe study will last for 12 months, starting from July 26, 2024, to July 25, 2025.\n\nData Collection:\n\nParticipants will complete seven assessments, including heart rate variability measurements and online questionnaires. The questionnaires will include the Patient Health Questionnaire-2 (PHQ-2), the Copenhagen Burnout Inventory (CBI), the Life and Cultural Adaptation Questionnaire, and the Language Proficiency Questionnaire.\n\nExpected Outcomes:\n\nThe study anticipates that the empowerment classes will reduce burnout symptoms and emotional stress, while enhancing cultural adaptation and language proficiency among migrant care workers.\n\nEthical Considerations:\n\nParticipation in this study is voluntary, and participants can withdraw at any time without negative consequences. All personal data will be kept confidential and used solely for research purposes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indonesian migrant care workers responsible for caring for patients in homes or care institutions.\n* Aged 18 years or older.\n\nExclusion Criteria:\n\n* Individuals unable to read the informed consent form or questionnaires in Indonesian.'}, 'identificationModule': {'nctId': 'NCT06532305', 'acronym': 'HOPE', 'briefTitle': 'Helping Overcome Pressure and Exhaustion: Empowerment Classes for Southeast Asian Migrant Care Workers', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Effects of Empowerment Classes on Burnout Syndrome and Emotional Stress Among Southeast Asian Migrant Care Workers: A Randomized Crossover Study', 'orgStudyIdInfo': {'id': '202406135RINE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Empowerment classes', 'description': 'Content:\n\nMental Health and Stress Management: Techniques and strategies for managing stress, mindfulness practices, and mental health awareness.\n\nDementia Care Skills: Training on dementia care, communication with dementia patients, and specific caregiving techniques.\n\nLanguage and Communication Skills: Improving proficiency in local languages and enhancing communication skills relevant to caregiving.\n\nFollow-up: After completing the empowerment classes, participants will switch to the social gatherings intervention.', 'interventionNames': ['Behavioral: HOPE empowerment classes']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Social gatherings', 'description': 'Content:\n\nSocial Interaction: Regular gatherings to promote social bonding and peer support among care workers.\n\nRecreational Activities: Group activities designed to foster relaxation and social engagement.\n\nInformal Discussions: Opportunities for care workers to share experiences and coping strategies in an informal setting.\n\nFollow-up: After completing the social gatherings, participants will switch to the empowerment classes intervention.', 'interventionNames': ['Behavioral: HOPE empowerment classes']}], 'interventions': [{'name': 'HOPE empowerment classes', 'type': 'BEHAVIORAL', 'description': 'A three-month empowerment course.', 'armGroupLabels': ['Empowerment classes', 'Social gatherings']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1002', 'city': 'Taipei', 'country': 'Taiwan', 'contacts': [{'name': 'I-Ming Chen, MD, PhD', 'role': 'CONTACT', 'email': 'iming@ntuh.gov.tw', 'phone': '886-2-23123456', 'phoneExt': '267991'}, {'name': 'I-Ming Chen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yu-Hsuan Lin, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Psychiatry, National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}