Getting INFORMED and Living Well Among Asian Americans in California

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Well-Being, Psychological
• Intervention / Treatment: Behavioral: INFORMED-Living Well; Behavioral: Text Messaging Only

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 Type: Interventional
• Enrollment (Actual): 616
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fresno, California, United States, 93727
      • The Fresno Center
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
    • San Francisco, California, United States, 94133
      • Chinese Community Health Resource Center
    • San Jose, California, United States, 95131
      • Immigrant Resettlement & Cultural Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: INFORMED-Living Well; 1) LHW outreach support providing responsive education and support; and 2) a 6-week automated SMS text messaging
Active Comparator: Text Messaging Only; Participants will have a 6-week SMS text messaging program identical to that received by the INFORMED-Living Well participants.	Behavioral: Text Messaging Only; A 6-week automated SMS text messaging

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: University of California, Davis; University of California, Merced; California Department of Public Health; Chinese Community Health Resource Center
• Investigators: Principal Investigator: Janice Tsoh, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: July 20, 2023
• First Submitted That Met QC Criteria: July 20, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Chinese; Vietnamese; Korean; Asian Americans; Immigrants; Peer Education; Hmong
• Other Study ID Numbers: P0567396

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No