Getting INFORMED and Living Well Among Asian Americans in California

Not Applicable

Completed

• Conditions: COVID-19; Well-Being, Psychological
• Interventions: Behavioral: INFORMED-Living Well; Behavioral: Text Messaging Only

• Registration Number: NCT05968300
• Lead Sponsor: University of California, San Francisco

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-07-20
• Study First Submitted QC: 2023-07-20
• Study First Posted: 2023-08-01
• Study Start: 2024-03-20
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 616

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INFORMED-Living Well	INFORMED-Living Well	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.
Text Messaging Only	Text Messaging Only	Participants will have a 6-week SMS text messaging program identical to that received by the INFORMED-Living Well participants.

Primary Outcome Measures

Name	Time	Method
Change in decisional conflict scale (SURE) scores	Baseline and 8-week follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Change in the percentage of participants' awareness of resources to get help or to learn more about improving emotional wellness	Baseline and 8-week follow-up	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.
Change in self-reported emotional wellness outcome	Baseline and 8-week follow-up	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.
Change in proportion of participants who have Intention to seek help for mental health	Baseline and 8-week follow-up	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).

Trial Locations

Locations (4)

The Fresno Center; 🇺🇸 Fresno, California, United States

Chinese Community Health Resource Center; 🇺🇸 San Francisco, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Immigrant Resettlement & Cultural Center; 🇺🇸 San Jose, California, United States