Getting INFORMED and Living Well Among Asian Americans in California

Study Overview
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Brief Summary
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The project is to facilitate pandemic recovery by promoting emotional wellness among Asian Californians. The intervention includes a 6-week program in which participants may choose to receive text only or text + Lay Health Worker outreach targeting 600 self-identified Asian Americans residing in California who speak/read English, Chinese, Korean, Hmong, or Vietnamese.

Detailed Description
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Investigators will conduct a non-randomized intervention trial (preference trial). Research participants involved in the trial will include 20 lay health workers (LHWs) and 600 trial participants with intervention delivered via SMS text messaging (for all participants), and the intervention group will receive educational intervention outreach from an LHW via Zoom or mutually agreed video conferencing online venues, and by telephone or instant messaging. Participants will choose which group they are in, SMS text messaging only or SMS text messaging plus educational outreach from an LHW.

Official Title
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Getting INFORMED and Living Well: A Demonstration Project to Facilitate Pandemic Recovery Among Asian Americans in California

Conditions
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COVID-19, Well-Being, Psychological

Intervention / Treatment
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* Behavioral: INFORMED-Living Well
* Behavioral: Text Messaging Only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: i) age 18 and older ii) speak Chinese, English, Hmong, Korean, or Vietnamese iii) self-identify as Asian American iv) have access to a mobile phone to receive SMS text messages Exclusion Criteria: unwilling to receive SMS text messages from the project

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-randomized trial (Preference trial)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INFORMED-Living Well<br>INFORMED-Living Well consists of two components: 1) LHW outreach support providing responsive education and support; and 2) a 6-week automated SMS text messaging. The LHW educational outreach component includes 2 small group educational sessions with 2-8 participants. Participants will also receive a weekly SMS Text or instant message on managing emotional wellness within and beyond the context of the COVID-19 pandemic over 6 weeks. In addition, participants will receive as-needed messages on updates of COVID-19 or other situations that may introduce new worries and tragic culturally-based traumatic events. | Behavioral: INFORMED-Living Well<br>* 1) LHW outreach support providing responsive education and support; and 2) a 6-week automated SMS text messaging<br>|
| Active Comparator: Text Messaging Only<br>Participants will have a 6-week SMS text messaging program identical to that received by the INFORMED-Living Well participants. | Behavioral: Text Messaging Only<br>* A 6-week automated SMS text messaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in decisional conflict scale (SURE) scores | Self-assessed perceptions of decision conflict will be assessed using the 4-item Decision Conflict Scale (SURE). Scores on the SURE scale range from 0 to 4, with higher scores indicating less decisional conflict. A score of less than 4 indicates decisional conflict. | Baseline and 8-week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in proportion of participants who have Intention to seek help for mental health | We will use a survey item to assess participants' intention to seek help for mental health issues when needed. A response will be 0 (No) or 1 (Yes). | Baseline and 8-week follow-up | 
| Change in self-reported emotional wellness outcome | We will use the four-item Patient Health Questionnaire (PHQ4) for measuring anxiety and depression symptoms. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score 3 or higher for the first 2 questions suggests anxiety, and total score 3 or higher for the last 2 questions suggests depression. | Baseline and 8-week follow-up | 
| Change in the percentage of participants' awareness of resources to get help or to learn more about improving emotional wellness | We will assess participants' awareness of resources to get help or to learn more about improving emotional wellness. Two items created for the study will be used: 1) Do you know about 988? (Yes, No, Unsure) 2) Do you know where to get help for mental health issues when you need to? (Yes, No, Unsure). The percentage of participants who answer yes to both questions will be assessed. | Baseline and 8-week follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asian Americans, Peer Education, Immigrants, Chinese, Hmong, Korean, Vietnamese