COVID-19NCT04474496
Impact of COVID-19 on Marshallese Communities in the U.S.
An observational study of COVID-19, run by University of Arkansas at 1 site in United States.
Trial summary
Marshallese adults in the U.S. will complete an online or telephone survey. This survey will collect data describing the impact of COVID-19 on Marshallese communities. Data collected will help describe: 1) risk exposure, 2) knowledge of preventive recommendations, 3) barriers and facilitators to implementing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Assessing the impact of COVID-19
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2020to 30 Nov 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult, Older adult
Study population: Self-reported Marshallese persons 18 years of age or older who live in the continental United States or Hawaii.
Who may be able to join
- Self-reported Marshallese
- 18 years of age or older
- Live in the Continental U.S. or Hawaii
Who cannot join
- Does not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences Northwest
Fayetteville, Arkansas, 72703
About this study
Marshallese adults in the U.S. will complete an online or telephone survey. This survey will collect data describing the impact of COVID-19 on Marshallese communities. Data collected will help describe: 1) risk exposure, 2) knowledge of preventive recommendations, 3) barriers and facilitators to implementing preventative recommendations, 4) barriers and facilitators to COVID-19 testing when appropriate, and 5) self-care behaviors during COVID-19. Participant inclusion criteria: 1) Self-reported Marshallese; 2) 18 years of age or older; 3) Live in the Continental U.S. or Hawaii.
Read the detailed description
Background and Rationale
While there is much we do not know about the differential effects of COVID-19, early data shows that minority communities are disproportionally effected by the virus. There are many factors that may increase the likelihood of contracting COVID-19 including: 1) community spread because of lack of access to testing in low-income communities, 2) work environments that may increase exposure, 3) more densely populated housing that reduces the ability to social distance, 4) limited understanding of preventive measures due to literacy and language barriers, 5) constrained financial resources to stay home and not work, and/or 6) lack of trust in the health care system. The Marshallese are a Pacific Islander population experiencing significant health disparities with some of the highest documented rates of type 2 diabetes mellitus (T2DM) of any population in the world. Estimated T2DM rates among Marshallese in the U.S. range from 25%-50%, much higher than the general U.S. population. People with T2DM are more likely to experience severe symptoms and complications when infected with COVID-19; however, those that manage their T2DM well are less likely to become extremely ill from the virus. In order to reduce the disparities caused by COVID-19 and ultimately compare the effectiveness of prevention interventions among the low-income minority communities most effected by COVID-19, it is critical to understand minority populations': 1) risk exposure, 2) knowledge of preventive recommendations, 3) barriers and facilitators to implementing preventative recommendations, 4) barriers and facilitators to COVID-19 testing when appropriate, and self-care behaviors during COVID-19.
Specific Aims
Aim 1: Document COVID-19 risk exposure for Marshallese community members.
Aim 2: Document Marshallese community members' knowledge of preventive recommendations.
Aim 3: Document barriers and facilitators to implementing preventative recommendations.
Aim 4: Document Marshallese community members' barriers and facilitators to COVID-19 testing when appropriate.
Aim 5: Document self-care behaviors during COVID-19.
Aim 6: Explore COVID-19 pandemic related barriers and facilitators to T2DM self-management among Marshallese adults with T2DM.
Aim 7: Assess the effect of the COVID-19 pandemic on T2DM self-management activities among Marshallese adults with T2DM.
Study Design and Procedures
Participants will complete an online or telephone survey. Up to 100 participants will also be invited to complete an in-depth qualitative interview in addition to the survey (these results are not presented here). Community-based recruitment for the online survey will be conducted by posting an informational flyer on social media. The flyer will contain a link to the study information sheet and survey documents. Study team members will also reach out to study participants via phone or electronic mediums (e.g. email, text, or messenger). Study staff will send potential participants a link to an electronic survey using REDcap. The REDcap system will include electronic documentation of consent prior to completing the survey. Access to study data will be limited to only those personnel who need it to complete relevant job duties. All data, regardless of whether it is identifiable or not, will be stored in a locked file cabinet in a locked room, or on a secure University of Arkansas for Medical Sciences (UAMS) server that requires two-factor authentication.Each participant who completes the survey will receive a $20 Walmart gift card as remuneration.
Measures/outcomes
Our survey will be based on CDC risk assessments and utilize the NIH funded COVID-19 items that are part of the PhenX Toolkit, as well as other standardized survey items/scales. Those participants with T2DM will be asked to complete questions pertaining to T2DM self-management during COVID-19.
Data Analysis
Given the descriptive nature of the study aims, the analytic strategy will focus on presenting results of item-level descriptive analyses, with an emphasis on frequencies and proportions. There will be no attempt to impute missing responses for any items. For each analysis, the number of included responses will be reported.
- Conditions
- COVID-19
- Being tested
- Assessing the impact of COVID-19
- Keywords
- Marshallese, Pacific Islanders, Type 2 Diabetes, COVID-19
- Medical subject headings
- COVID-19, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessing the impact of COVID-19Other
Surveying Marshallese adults in the U.S. to determine the impact of COVID-19
| Study group | Role | What they receive |
|---|---|---|
| Marshallese adults in the U.S. | Marshallese persons 18 years of age or older currently residing in the United States Receives: Other: Assessing the impact of COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Preventative Behaviors to Decrease Risk of COVID-19 Exposure
Participants will report behaviors they regularly engage in to lessen their risk of contracting COVID-19 (e.g., social distancing, wearing a mask, etc.). Participants were asked "Which of the following measures have you taken to prevent infection from COVID-19? (Select all that apply)"
Measured: Baseline
Workplace Preventative Actions to Decrease Risk of COVID-19 Exposure
Participants will report specific steps taken by their employers to reduce risk of contracting COVID-19 (e.g., requiring remote work, mask mandates, etc.). Participants were asked to "Please check all of the following your workplace has done since the COVID-19 outbreak (Select all that apply)".
Measured: Baseline
Secondary outcomes (16)
Effects of COVID-19 on General Health Status
Participants will be asked to rate their general health status compared with before the COVID-19 outbreak. Participants were asked "Compared to the time before the COVID-19 outbreak, is your physical health status better, worse, or about the same?"
Measured: Baseline
Effects of COVID-19 on Access to Healthcare Services
Participants will be asked to report ways in which the COVID-19 pandemic has disrupted access to healthcare (e.g., seeking routine care, getting necessary medications, etc.). Participants were asked "In what ways has the COVID-19 outbreak affected your overall healthcare? (Select all that apply)".
Measured: Baseline
Effects of COVID-19 on Dietary Habits
Participants will be asked to compare their current dietary behaviors with before the COVID-19 outbreak. Participants were asked "How do you think your eating habits have changed compared to before the COVID-19 outbreak?"
Measured: Baseline
Effects of COVID-19 on Physical Activity Behaviors (Not Specifically for Exercise)
After reporting how many times per week they engaged "in at least 30 minutes of physical activity that was not specifically for exercise (total minutes of continuous activity, including walking, yard work, construction work, etc.)", participants were then asked "Is this more, less or about the same as the number of days you participated in at least 30 minutes of physical activity that was not specifically for exercise (total minutes of continuous activity, including walking, yard work, construction work, etc.) in a typical week before the COVID-19 outbreak?"
Measured: Baseline
Effects of COVID-19 on Physical Activity Behaviors (Specifically for Exercise)
After reporting how many times per week they engaged "in at least 30 minutes of a specific exercise session (such as swimming, walking specifically for exercise, biking, etc.)", participants were then asked "Is this more, less or about the same as the number of days you participated in at least 30 minutes of a specific exercise session (such as swimming, walking specifically for exercise, biking etc.) in a typical week before the COVID-19 outbreak?"
Measured: Baseline
Effects of COVID-19 on Weight
Participants were asked to report changes in weight. Participants were asked "Have you noticed your weight change since the COVID-19 outbreak?"
Measured: Baseline
Effects of COVID-19 on HbA1c (Glycated Hemoglobin)
After reporting their most recent HbA1c reading, participants were then asked "How different was this HbA1c reading from your average HbA1c reading before the COVID-19 outbreak?"
Measured: Baseline
Barriers to Type 2 Diabetes Management Due to COVID-19
Participants with type 2 diabetes were asked to report how the COVID-19 outbreak affected their access to type 2 diabetes supplies (insulin, needles, etc.). Participants were asked "Has the COVID-19 outbreak affected your level of access to the following? (Select all that apply)"
Measured: Baseline
COVID-19 Screening
Participants were asked to report whether they have been screened for COVID-19 and by what method (by phone, online, at work, etc.). Participants were asked "Were you screened for COVID-19? (Select all that apply)".
Measured: Baseline
COVID-19 Testing
Participants were asked to report whether they have been tested for COVID-19 and the results of the test. Participants were asked "Have you had the nose swab test for the virus that causes COVID-19? (Mark all that apply)"
Measured: Baseline
COVID-19 Vaccine Willingness/Hesitancy
Participants were asked to report whether they would accept a COVID-19 vaccine. Participants were asked "If a vaccine for COVID-19 were available today, what is the likelihood that you would get vaccinated?"
Measured: Baseline
Trusted Sources of COVID-19 Information
Participants were asked to report which sources of information they trust the most to stay informed about COVID-19. Participants were asked "What resource do you trust most for reliable information about COVID-19?"
Measured: Baseline
Effects of COVID-19 on Housing
Participants were asked how COVID-19 has impacted their housing situation. Participants were asked "Please check all of the following that have happened to you since the COVID-19 outbreak".
Measured: Baseline
Effects of COVID-19 on Employment
Participants were asked how COVID-19 has impacted their employment. Participants were asked "In what ways has the COVID-19 outbreak affected your work? (Select all that apply)".
Measured: Baseline
Effects of COVID-19 on Income
Participants were asked how COVID-19 has impacted their income. Participants were asked "As a result of COVID-19, has your family income changed?"
Measured: Baseline
Sources of Stress During COVID-19
Participants were asked to report their greatest sources of stress from the COVID-19 outbreak (e.g., health concerns, financial concerns, etc.). Participants were asked "What have been your greatest sources of stress from the COVID-19 outbreak? (Select all that apply)"
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start27 Jul 2020
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Pearl A McElfish, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474496
- Sponsor's protocol ID
- 261131
- Status last verified
- Apr 2021
- First submitted
- 10 Jul 2020
- Last updated
- 5 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of COVID-19 on Marshallese Communities in the U.S.
- ClinicalTrials.gov ID
- NCT04474496
- Acronym / sponsor ID
- 261131
- Conditions
- COVID-19
- Keywords
- Marshallese, Pacific Islanders, Type 2 Diabetes, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 16 Jul 2020 (actual)
- Results
- Posted 5 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Marshallese adults in the U.S. will complete an online or telephone survey. This survey will collect data describing the impact of COVID-19 on Marshallese communities. Data collected will help describe: 1) risk exposure, 2) knowledge of preventive recommendations, 3) barriers and facilitators to implementing preventative recommendations, 4) barriers and facilitators to COVID-19 testing when appropriate, and 5) self-care behaviors during COVID-19. Participant inclusion criteria: 1) Self-reported Marshallese; 2) 18 years of age or older; 3) Live in the Continental U.S. or Hawaii.
Detailed description
Background and Rationale
While there is much we do not know about the differential effects of COVID-19, early data shows that minority communities are disproportionally effected by the virus. There are many factors that may increase the likelihood of contracting COVID-19 including: 1) community spread because of lack of access to testing in low-income communities, 2) work environments that may increase exposure, 3) more densely populated housing that reduces the ability to social distance, 4) limited understanding of preventive measures due to literacy and language barriers, 5) constrained financial resources to stay home and not work, and/or 6) lack of trust in the health care system. The Marshallese are a Pacific Islander population experiencing significant health disparities with some of the highest documented rates of type 2 diabetes mellitus (T2DM) of any population in the world. Estimated T2DM rates among Marshallese in the U.S. range from 25%-50%, much higher than the general U.S. population. People with T2DM are more likely to experience severe symptoms and complications when infected with COVID-19; however, those that manage their T2DM well are less likely to become extremely ill from the virus. In order to reduce the disparities caused by COVID-19 and ultimately compare the effectiveness of prevention interventions among the low-income minority communities most effected by COVID-19, it is critical to understand minority populations': 1) risk exposure, 2) knowledge of preventive recommendations, 3) barriers and facilitators to implementing preventative recommendations, 4) barriers and facilitators to COVID-19 testing when appropriate, and self-care behaviors during COVID-19.
Specific Aims
Aim 1: Document COVID-19 risk exposure for Marshallese community members.
Aim 2: Document Marshallese community members' knowledge of preventive recommendations.
Aim 3: Document barriers and facilitators to implementing preventative recommendations.
Aim 4: Document Marshallese community members' barriers and facilitators to COVID-19 testing when appropriate.
Aim 5: Document self-care behaviors during COVID-19.
Aim 6: Explore COVID-19 pandemic related barriers and facilitators to T2DM self-management among Marshallese adults with T2DM.
Aim 7: Assess the effect of the COVID-19 pandemic on T2DM self-management activities among Marshallese adults with T2DM.
Study Design and Procedures
Participants will complete an online or telephone survey. Up to 100 participants will also be invited to complete an in-depth qualitative interview in addition to the survey (these results are not presented here). Community-based recruitment for the online survey will be conducted by posting an informational flyer on social media. The flyer will contain a link to the study information sheet and survey documents. Study team members will also reach out to study participants via phone or electronic mediums (e.g. email, text, or messenger). Study staff will send potential participants a link to an electronic survey using REDcap. The REDcap system will include electronic documentation of consent prior to completing the survey. Access to study data will be limited to only those personnel who need it to complete relevant job duties. All data, regardless of whether it is identifiable or not, will be stored in a locked file cabinet in a locked room, or on a secure University of Arkansas for Medical Sciences (UAMS) server that requires two-factor authentication.Each participant who completes the survey will receive a $20 Walmart gift card as remuneration.
Measures/outcomes
Our survey will be based on CDC risk assessments and utilize the NIH funded COVID-19 items that are part of the PhenX Toolkit, as well as other standardized survey items/scales. Those participants with T2DM will be asked to complete questions pertaining to T2DM self-management during COVID-19.
Data Analysis
Given the descriptive nature of the study aims, the analytic strategy will focus on presenting results of item-level descriptive analyses, with an emphasis on frequencies and proportions. There will be no attempt to impute missing responses for any items. For each analysis, the number of included responses will be reported.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Marshallese adults in the U.S. | – | Other: Assessing the impact of COVID-19Marshallese persons 18 years of age or older currently residing in the United States |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Self-reported Marshallese persons 18 years of age or older who live in the continental United States or Hawaii.
Key inclusion criteria (3 listed)
- Self-reported Marshallese
- 18 years of age or older
- Live in the Continental U.S. or Hawaii
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria
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 |
|---|---|---|
| Assessing the impact of COVID-19Surveying Marshallese adults in the U.S. to determine the impact of COVID-19 | Other | Marshallese adults in the U.S. |
Primary outcome
Personal Preventative Behaviors to Decrease Risk of COVID-19 Exposure
Time frame: Baseline
Participants will report behaviors they regularly engage in to lessen their risk of contracting COVID-19 (e.g., social distancing, wearing a mask, etc.). Participants were asked "Which of the following measures have you taken to prevent infection from COVID-19? (Select all that apply)"
Workplace Preventative Actions to Decrease Risk of COVID-19 Exposure
Time frame: Baseline
Participants will report specific steps taken by their employers to reduce risk of contracting COVID-19 (e.g., requiring remote work, mask mandates, etc.). Participants were asked to "Please check all of the following your workplace has done since the COVID-19 outbreak (Select all that apply)".
16 secondary outcomes
Effects of COVID-19 on General Health Status
Time frame: Baseline
Effects of COVID-19 on Access to Healthcare Services
Time frame: Baseline
Effects of COVID-19 on Dietary Habits
Time frame: Baseline
Effects of COVID-19 on Physical Activity Behaviors (Not Specifically for Exercise)
Time frame: Baseline
Effects of COVID-19 on Physical Activity Behaviors (Specifically for Exercise)
Time frame: Baseline
Effects of COVID-19 on Weight
Time frame: Baseline
Effects of COVID-19 on HbA1c (Glycated Hemoglobin)
Time frame: Baseline
Barriers to Type 2 Diabetes Management Due to COVID-19
Time frame: Baseline
COVID-19 Screening
Time frame: Baseline
COVID-19 Testing
Time frame: Baseline
COVID-19 Vaccine Willingness/Hesitancy
Time frame: Baseline
Trusted Sources of COVID-19 Information
Time frame: Baseline
Effects of COVID-19 on Housing
Time frame: Baseline
Effects of COVID-19 on Employment
Time frame: Baseline
Effects of COVID-19 on Income
Time frame: Baseline
Sources of Stress During COVID-19
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Pearl A McElfish, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by University of Arkansas at 1 site 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 3 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 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 5 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Personal Preventative Behaviors to Decrease Risk of COVID-19 Exposure (time frame: Baseline). The study lists 2 primary outcomes in all. 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 5 Apr 2021.