- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06532305
Helping Overcome Pressure and Exhaustion: Empowerment Classes for Southeast Asian Migrant Care Workers (HOPE)
The Effects of Empowerment Classes on Burnout Syndrome and Emotional Stress Among Southeast Asian Migrant Care Workers: A Randomized Crossover Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Design:
The 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.
Duration:
The study will last for 12 months, starting from July 26, 2024, to July 25, 2025.
Data Collection:
Participants 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.
Expected Outcomes:
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.
Ethical Considerations:
Participation 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taipei, Taiwan, 1002
- Department of Psychiatry, National Taiwan University Hospital
-
Principal Investigator:
- I-Ming Chen, MD, PhD
-
Contact:
- I-Ming Chen, MD, PhD
- Phone Number: 267991 886-2-23123456
- Email: iming@ntuh.gov.tw
-
Sub-Investigator:
- Yu-Hsuan Lin, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Indonesian migrant care workers responsible for caring for patients in homes or care institutions.
- Aged 18 years or older.
Exclusion Criteria:
- Individuals unable to read the informed consent form or questionnaires in Indonesian.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Empowerment classes
Content: Mental Health and Stress Management: Techniques and strategies for managing stress, mindfulness practices, and mental health awareness. Dementia Care Skills: Training on dementia care, communication with dementia patients, and specific caregiving techniques. Language and Communication Skills: Improving proficiency in local languages and enhancing communication skills relevant to caregiving. Follow-up: After completing the empowerment classes, participants will switch to the social gatherings intervention. |
A three-month empowerment course.
|
|
Active Comparator: Social gatherings
Content: Social Interaction: Regular gatherings to promote social bonding and peer support among care workers. Recreational Activities: Group activities designed to foster relaxation and social engagement. Informal Discussions: Opportunities for care workers to share experiences and coping strategies in an informal setting. Follow-up: After completing the social gatherings, participants will switch to the empowerment classes intervention. |
A three-month empowerment course.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate Variability
Time Frame: 12 months
|
Heart Rate Variability measurements will be used to assess changes in autonomic nervous system function, providing an objective measure of stress levels.
|
12 months
|
|
Burnout levels
Time Frame: 12 months
|
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.
|
12 months
|
|
Emotional Stress
Time Frame: 12 months
|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cultural Adaptation
Time Frame: 12 months
|
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.
|
12 months
|
|
Language Proficiency
Time Frame: 12 months
|
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.
|
12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202406135RINE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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