Impact of COVID-19 on Marshallese Communities in the U.S.

COVID-19 Clinical Trial

Official title:

Impact of COVID-19 on Marshallese Communities in the U.S.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04474496
• Other study ID #: 261131
• Status: Completed
• Start date: July 27, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: April 2021
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Self-reported Marshallese

• 18 years of age or older

• Live in the Continental U.S. or Hawaii

Exclusion Criteria:

• Does not meet inclusion criteria

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• Assessing the impact of COVID-19
Surveying Marshallese adults in the U.S. to determine the impact of COVID-19

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences Northwest	Fayetteville	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)"	Baseline
Primary	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)".	Baseline
Secondary	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?"	Baseline
Secondary	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)".	Baseline
Secondary	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?"	Baseline
Secondary	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?"	Baseline
Secondary	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?"	Baseline
Secondary	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?"	Baseline
Secondary	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?"	Baseline
Secondary	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)"	Baseline
Secondary	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)".	Baseline
Secondary	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)"	Baseline
Secondary	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?"	Baseline
Secondary	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?"	Baseline
Secondary	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".	Baseline
Secondary	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)".	Baseline
Secondary	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?"	Baseline
Secondary	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)"	Baseline