COVID-19NCT05968300
Getting INFORMED and Living Well Among Asian Americans in California
A study testing INFORMED-Living Well and Text Messaging Only in people with COVID-19 and Well-Being, Psychological, run by University of California, San Francisco at 4 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Well-Being, Psychological
- What is being tested?
- INFORMED-Living Well and Text Messaging Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 616 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Mar 2024to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 and older
- speak Chinese, English, Hmong, Korean, or Vietnamese
- self-identify as Asian American
- have access to a mobile phone to receive SMS text messages
Who cannot join
- unwilling to receive SMS text messages from the project
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The Fresno Center
Fresno, California, 93727
Chinese Community Health Resource Center
San Francisco, California, 94133
University of California, San Francisco
San Francisco, California, 94143
Immigrant Resettlement & Cultural Center
San Jose, California, 95131
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19, Well-Being, Psychological
- Being tested
- INFORMED-Living Well, Text Messaging Only
- Keywords
- Asian Americans, Peer Education, Immigrants, Chinese, Hmong, Korean, Vietnamese
- Medical subject headings
- COVID-19, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INFORMED-Living WellBehavioural
- LHW outreach support providing responsive education and support; and 2) a 6-week automated SMS text messaging
Text Messaging OnlyBehavioural
A 6-week automated SMS text messaging
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Text Messaging Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 8-week follow-up
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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.
Measured: Baseline and 8-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start20 Mar 2024
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomized trial (Preference trial)
- Masking
- None (open label)
- Enrolment
- 616 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Community Health Resource Center, University of California, Davis, University of California, Merced, California Department of Public Health
- Responsible party
- Sponsor
- Investigators
- Janice Tsoh, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968300
- Sponsor's protocol ID
- P0567396
- Status last verified
- Nov 2024
- First submitted
- 20 Jul 2023
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Getting INFORMED and Living Well: A Demonstration Project to Facilitate Pandemic Recovery Among Asian Americans in California
- ClinicalTrials.gov ID
- NCT05968300
- Acronym / sponsor ID
- P0567396
- Conditions
- COVID-19, Well-Being, Psychological
- Keywords
- Asian Americans, Peer Education, Immigrants, Chinese, Hmong, Korean, Vietnamese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 616 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Chinese Community Health Resource Center, University of California, Davis, University of California, Merced, California Department of Public Health
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-randomized trial (Preference trial)
| Arm | Type | Receives |
|---|---|---|
| INFORMED-Living Well | Experimental | Behavioral: INFORMED-Living WellINFORMED-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 | Active comparator | Behavioral: Text Messaging OnlyParticipants will have a 6-week SMS text messaging program identical to that received by the INFORMED-Living Well participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 and older
- speak Chinese, English, Hmong, Korean, or Vietnamese
- self-identify as Asian American
- have access to a mobile phone to receive SMS text messages
Key exclusion criteria (1 listed)
- unwilling to receive SMS text messages from the project
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INFORMED-Living Well1) LHW outreach support providing responsive education and support; and 2) a 6-week automated SMS text messaging | Behavioural | INFORMED-Living Well |
| Text Messaging OnlyA 6-week automated SMS text messaging | Behavioural | Text Messaging Only |
Primary outcome
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.
3 secondary outcomes
Change in proportion of participants who have Intention to seek help for mental health
Time frame: Baseline and 8-week follow-up
Change in self-reported emotional wellness outcome
Time frame: 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
Time frame: Baseline and 8-week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice Tsoh, PhD principal investigator
University of California, San Francisco
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INFORMED-Living Well and Text Messaging Only in people with COVID-19 and Well-Being, Psychological, run by University of California, San Francisco at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in decisional conflict scale (SURE) scores (time frame: Baseline and 8-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.