Getting INFORMED and Living Well Among Asian Americans in California

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05968300
• Other study ID #: P0567396
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 20, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: June 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: August 31, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Behavioral:
• INFORMED-Living Well
1) LHW outreach support providing responsive education and support; and 2) a 6-week automated SMS text messaging
• Text Messaging Only
A 6-week automated SMS text messaging

Locations

Country	Name	City	State
United States	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

Sponsors (5)

Lead Sponsor	Collaborator
University of California, San Francisco	California Department of Public Health, Chinese Community Health Resource Center, University of California, Davis, University of California, Merced

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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