NCT05968300

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
616

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

March 20, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

July 20, 2023

Last Update Submit

November 20, 2024

Conditions

Keywords

Asian AmericansPeer EducationImmigrantsChineseHmongKoreanVietnamese

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

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

    Baseline and 8-week follow-up

  • Change in self-reported emotional wellness outcome

    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

    Baseline and 8-week follow-up

Study Arms (2)

INFORMED-Living Well

EXPERIMENTAL

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

Text Messaging Only

ACTIVE COMPARATOR

Participants will have a 6-week SMS text messaging program identical to that received by the INFORMED-Living Well participants.

Behavioral: Text Messaging Only

Interventions

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

INFORMED-Living Well

A 6-week automated SMS text messaging

Text Messaging Only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • unwilling to receive SMS text messages from the project

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

The Fresno Center

Fresno, California, 93727, United States

Location

Chinese Community Health Resource Center

San Francisco, California, 94133, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Immigrant Resettlement & Cultural Center

San Jose, California, 95131, United States

Location

MeSH Terms

Conditions

COVID-19Psychological Well-Being

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPersonal SatisfactionBehavior

Study Officials

  • Janice Tsoh, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Non-randomized trial (Preference trial)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2023

First Posted

August 1, 2023

Study Start

March 20, 2024

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

November 22, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations