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This study aims to pilot test a culturally tailored behavioral intervention called "WECARE" to enhance caregiving mastery and improve psychosocial wellbeing of Chinese American family caregivers of persons with Alzheimer's Disease and related dementia.
The investigators propose to test a culturally tailored mHealth behavioral intervention to enhance caregiving mastery and improve psychosocial wellbeing among Chinese American family caregivers of persons living with Alzheimer's Disease and related dementia. This intervention, Wellness Enhancement for Caregivers (WECARE), will be delivered via WeChat, a social media app highly popular among Chinese Americans. About 45 participants will be recruited for the pilot test. Participants will complete a baseline survey, receive 7-week WECARE program on their WeChat accounts, complete a follow-up survey 12 weeks after the baseline, and then a qualitative interview on Zoom.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WECARE | Experimental | Participants will first complete a baseline survey online, then subscribe to the WECARE official account on their own WeChat accounts and begin receiving the 7-week interactive and personalized program. The program content includes short video clips, pictorial messages, and audio recordings. Each week, the WECARE program is focused on a theme aimed to increase participants' caregiving mastery, enhance self-care, and improve psychosocial wellbeing. Four weeks after the intervention or 11 weeks after the baseline, participants will complete a follow-up survey online. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wellness Enhancement for Caregivers (WECARE) | Behavioral | WECARE behavioral intervention is guided by behavioral theories aimed to increase participants' caregiving mastery, enhance self-care, and improve psychosocial wellbeing. Participants will receive multimedia content on their WeChat account on cellphone or tablet, including short video clips, pictorial messages, short articles, and audio recordings 6 days a week, for 7 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Behavioral Intervention in Change From Baseline in Depressive Symptoms | The baseline and follow-up differences in depressive symptoms will be assessed using the Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D is a 20-item survey instrument designed to measure the frequency and severity of depressive symptoms. The total score is calculated by summing the responses to all 20 items. The total scale ranges from 0 to 60, with higher scores indicating more severe depressive symptoms (a worse outcome). The primary analysis will calculate the difference in this total score between baseline and follow-up. adults and dementia caregivers. | Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Behavioral Intervention in Change From Baseline in Caregiving Burden | The baseline and follow-up differences in caregiving burden will be assessed using the 12-item Zarit Burden Interview (ZBI-12). The ZBI-12 is designed to measure the subjective physical, psychological, and social burden experienced by caregivers. Each item is rated on a 5-point scale from "never" (0) to "nearly always" (4), The total score is calculated by summing the responses to all 12 items. The total scale ranges from 0 to 48, with higher scores indicating greater caregiving burden (a worse outcome). The primary analysis will calculate the difference in this total score between baseline and follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Behavioral Intervention in Change From Baseline in Caregiving Mastery | The baseline and follow-up differences in caregiving mastery will be assessed using the Caregiving Mastery Scale. This 7-item survey instrument is designed to measure a caregiver's self-perception of their ability to effectively manage caregiving tasks and challenges. The total score is calculated by summing the responses to all 7 items. The total scale ranges from 0 to 28, with higher scores indicating greater caregiving mastery (a better outcome). The primary analysis will calculate the difference in this total score between baseline and follow-up. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alicia Hong | George Mason University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Mason University | Fairfax | Virginia | 22030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40955511 | Derived | Shen K, Hong YA, Zhang YJ, Han HR, Lin J, Hepburn K. Process evaluation of a digital health intervention for dementia caregivers: Integrating active and passive measurements. Alzheimers Dement. 2025 Sep;21(9):e70663. doi: 10.1002/alz.70663. |
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Given the small sample size, we will not make individual participant data available to the public.
After the investigators completes primary data collection and the first report from this trial is accepted for publication.
Researchers will submit a request including the purpose of accessing the data and a data user agreement
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Some articipants are recruited through the UCSF CARE registry. Most participants are recruited through with our community partners located in Washington DC and New York. Recruitment flyers will be sent to communities via social media outlets or e-newsletters. Eligibility for study participation will be determined through telephone screenings conducted by trained research personnel.
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| ID | Title | Description |
|---|---|---|
| FG000 | WECARE | Participants will first complete a baseline survey online, then subscribe to the WECARE official account on their own WeChat accounts and begin receiving the 7-week interactive and personalized program. The program content includes short video clips, pictorial messages, and audio recordings. Each week, the WECARE program is focused on a theme aimed to increase participants' caregiving mastery, enhance self-care, and improve psychosocial wellbeing. Four weeks after the intervention or 11 weeks after the baseline, participants will complete a follow-up survey online. Wellness Enhancement for Caregivers (WECARE): WECARE behavioral intervention is guided by behavioral theories aimed to increase participants' caregiving mastery, enhance self-care, and improve psychosocial wellbeing. Participants will receive multimedia content on their WeChat account on cellphone or tablet, including short video clips, pictorial messages, short articles, and audio recordings 6 days a week, for 7 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All participants are Chinese Americans, recruited in United States.
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| ID | Title | Description |
|---|---|---|
| BG000 | WECARE | Participants will first complete a baseline survey online, then subscribe to the WECARE official account on their own WeChat accounts and begin receiving the 7-week interactive and personalized program. The program content includes short video clips, pictorial messages, and audio recordings. Each week, the WECARE program is focused on a theme aimed to increase participants' caregiving mastery, enhance self-care, and improve psychosocial wellbeing. Four weeks after the intervention or 11 weeks after the baseline, participants will complete a follow-up survey online. Wellness Enhancement for Caregivers (WECARE): WECARE behavioral intervention is guided by behavioral theories aimed to increase participants' caregiving mastery, enhance self-care, and improve psychosocial wellbeing. Participants will receive multimedia content on their WeChat account on cellphone or tablet, including short video clips, pictorial messages, short articles, and audio recordings 6 days a week, for 7 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy of Behavioral Intervention in Change From Baseline in Depressive Symptoms | The baseline and follow-up differences in depressive symptoms will be assessed using the Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D is a 20-item survey instrument designed to measure the frequency and severity of depressive symptoms. The total score is calculated by summing the responses to all 20 items. The total scale ranges from 0 to 60, with higher scores indicating more severe depressive symptoms (a worse outcome). The primary analysis will calculate the difference in this total score between baseline and follow-up. adults and dementia caregivers. | Posted | Mean | Standard Deviation | score on a scale | Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention) |
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From baseline through the post-intervention follow-up assessment at Weeks 11-12.
Adverse events were monitored during the study period. No deaths, serious adverse events, or other adverse events were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | WECARE | Participants will first complete a baseline survey online, then subscribe to the WECARE official account on their own WeChat accounts and begin receiving the 7-week interactive and personalized program. The program content includes short video clips, pictorial messages, and audio recordings. Each week, the WECARE program is focused on a theme aimed to increase participants' caregiving mastery, enhance self-care, and improve psychosocial wellbeing. Four weeks after the intervention or 11 weeks after the baseline, participants will complete a follow-up survey online. Wellness Enhancement for Caregivers (WECARE): WECARE behavioral intervention is guided by behavioral theories aimed to increase participants' caregiving mastery, enhance self-care, and improve psychosocial wellbeing. Participants will receive multimedia content on their WeChat account on cellphone or tablet, including short video clips, pictorial messages, short articles, and audio recordings 6 days a week, for 7 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Y. Alicia Hong | George Mason University | 7039931929 | yhong22@gmu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 31, 2023 | Aug 20, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 31, 2023 | Aug 20, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 31, 2023 | Apr 14, 2026 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D017028 | Caregivers |
| ID | Term |
|---|---|
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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| Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention) |
| Efficacy of Behavioral Intervention in Change From Baseline in Life Satisfaction | The baseline and follow-up differences in life satisfaction will be assessed using the Satisfaction with Life Scale (SWLS). The SWLS is a 5-item survey instrument designed to measure a person's global cognitive judgments of satisfaction with their life. The total score is calculated by summing the responses to all 5 items. The total scale ranges from 0 to 30, with higher scores indicating greater life satisfaction (a better outcome). The primary analysis will calculate the difference in this total score between baseline and follow-up. | Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention) |
| Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention) |
| Efficacy of Behavioral Intervention in Change in Care-recipient's Problem Behaviors | The baseline and follow-up differences in care-recipient problem behaviors will be assessed using the Revised Memory and Problem Behavior Checklist (RMBPC). The RMBPC is a 24-item survey instrument designed to measure observable behavioral problems in care recipients across three subdomains: memory-related issues, depressive behaviors, and disruptive behaviors. The total score is calculated by summing the Yes (1) or No (0) responses to all 24 items. The total scale ranges from 0 to 24, with higher scores indicating a higher frequency of problem behaviors (a worse outcome). The primary analysis will calculate the difference in this total score between baseline and follow-up. | Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention) |
| Efficacy of Behavioral Intervention in Change From Baseline in Positive Aspect of Caregiving | The baseline and follow-up differences in caregivers' positive aspects of caregiving will be measured by Positive Aspects of Caregiving Scale, a 9-item scale 5-point Likert scale from 0 to 4, with total scores ranging from 0 to 36, with higher score indicating more positive perception of caregiving. The baseline and follow-up differences in the scores will be calculated. | Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention) |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Efficacy of Behavioral Intervention in Change From Baseline in Caregiving Burden | The baseline and follow-up differences in caregiving burden will be assessed using the 12-item Zarit Burden Interview (ZBI-12). The ZBI-12 is designed to measure the subjective physical, psychological, and social burden experienced by caregivers. Each item is rated on a 5-point scale from "never" (0) to "nearly always" (4), The total score is calculated by summing the responses to all 12 items. The total scale ranges from 0 to 48, with higher scores indicating greater caregiving burden (a worse outcome). The primary analysis will calculate the difference in this total score between baseline and follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention) |
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| Secondary | Efficacy of Behavioral Intervention in Change From Baseline in Life Satisfaction | The baseline and follow-up differences in life satisfaction will be assessed using the Satisfaction with Life Scale (SWLS). The SWLS is a 5-item survey instrument designed to measure a person's global cognitive judgments of satisfaction with their life. The total score is calculated by summing the responses to all 5 items. The total scale ranges from 0 to 30, with higher scores indicating greater life satisfaction (a better outcome). The primary analysis will calculate the difference in this total score between baseline and follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention) |
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| Other Pre-specified | Efficacy of Behavioral Intervention in Change From Baseline in Caregiving Mastery | The baseline and follow-up differences in caregiving mastery will be assessed using the Caregiving Mastery Scale. This 7-item survey instrument is designed to measure a caregiver's self-perception of their ability to effectively manage caregiving tasks and challenges. The total score is calculated by summing the responses to all 7 items. The total scale ranges from 0 to 28, with higher scores indicating greater caregiving mastery (a better outcome). The primary analysis will calculate the difference in this total score between baseline and follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention) |
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| Other Pre-specified | Efficacy of Behavioral Intervention in Change in Care-recipient's Problem Behaviors | The baseline and follow-up differences in care-recipient problem behaviors will be assessed using the Revised Memory and Problem Behavior Checklist (RMBPC). The RMBPC is a 24-item survey instrument designed to measure observable behavioral problems in care recipients across three subdomains: memory-related issues, depressive behaviors, and disruptive behaviors. The total score is calculated by summing the Yes (1) or No (0) responses to all 24 items. The total scale ranges from 0 to 24, with higher scores indicating a higher frequency of problem behaviors (a worse outcome). The primary analysis will calculate the difference in this total score between baseline and follow-up. | Care recipients were not enrolled as study participants. This outcome was reported by enrolled caregivers using the Revised Memory and Problem Behavior Checklist to assess problem behaviors of the person with dementia for whom they provided care. The analysis population includes the 45 caregivers who completed both baseline and follow-up surveys. | Posted | Mean | Standard Deviation | score on a scale | Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention) |
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| Other Pre-specified | Efficacy of Behavioral Intervention in Change From Baseline in Positive Aspect of Caregiving | The baseline and follow-up differences in caregivers' positive aspects of caregiving will be measured by Positive Aspects of Caregiving Scale, a 9-item scale 5-point Likert scale from 0 to 4, with total scores ranging from 0 to 36, with higher score indicating more positive perception of caregiving. The baseline and follow-up differences in the scores will be calculated. | Posted | Mean | Standard Deviation | score on a scale | Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention) |
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