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Completed

NCT Number: NCT05968300

Getting INFORMED and Living Well 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.

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Key information

Conditions

COVID-19 Behavior Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Personal Satisfaction Pneumonia Pneumonia, Viral Psychological Well-Being RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases Well-Being, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Fresno Center, Fresno, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

INFORMED-Living Well

Behavioral
  • LHW outreach support providing responsive education and support; and 2) a 6-week automated SMS text messaging

Text Messaging Only

Behavioral

A 6-week automated SMS text messaging

Primary outcomes

  1. Change in decisional conflict scale (SURE) scores

    Time frame: 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 outcomes

  1. Change in proportion of participants who have Intention to seek help for mental health

    Time frame: 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).

  2. Change in self-reported emotional wellness outcome

    Time frame: 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.

  3. Change in the percentage of participants' awareness of resources to get help or to learn more about improving emotional wellness

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • California Department of Public Health
  • Chinese Community Health Resource Center
  • University of California, Davis
  • University of California, Merced

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2023
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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