Clinical trial NCT04474496: Impact of COVID-19 on Marshallese Communities in the U.S.
Official title: Impact of COVID-19 on Marshallese Communities in the U.S.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: Marshallese
Pacific Islanders
Type 2 Diabetes
COVID-19
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2020-07-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Self-reported Marshallese persons 18 years of age or older who live in the continental United States or Hawaii.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Personal Preventative Behaviors to Decrease Risk of COVID-19 Exposure
timeFrame: Baseline
measure: Workplace Preventative Actions to Decrease Risk of COVID-19 Exposure
timeFrame: Baseline
Secondary outcomes:
measure: Effects of COVID-19 on General Health Status
timeFrame: Baseline
measure: Effects of COVID-19 on Access to Healthcare Services
timeFrame: Baseline
measure: Effects of COVID-19 on Dietary Habits
timeFrame: Baseline
measure: Effects of COVID-19 on Physical Activity Behaviors (Not Specifically for Exercise)
timeFrame: Baseline
measure: Effects of COVID-19 on Physical Activity Behaviors (Specifically for Exercise)
timeFrame: Baseline
measure: Effects of COVID-19 on Weight
timeFrame: Baseline
measure: Effects of COVID-19 on HbA1c (Glycated Hemoglobin)
timeFrame: Baseline
measure: Barriers to Type 2 Diabetes Management Due to COVID-19
timeFrame: Baseline
measure: COVID-19 Screening
timeFrame: Baseline
measure: COVID-19 Testing
timeFrame: Baseline
measure: COVID-19 Vaccine Willingness/Hesitancy
timeFrame: Baseline
measure: Trusted Sources of COVID-19 Information
timeFrame: Baseline
measure: Effects of COVID-19 on Housing
timeFrame: Baseline
measure: Effects of COVID-19 on Employment
timeFrame: Baseline
measure: Effects of COVID-19 on Income
timeFrame: Baseline
measure: Sources of Stress During COVID-19
timeFrame: Baseline
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: University of Arkansas for Medical Sciences Northwest
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Pearl A McElfish, PhD
role: PRINCIPAL_INVESTIGATOR
References: