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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Marshallese adults in the U.S. | Marshallese persons 18 years of age or older currently residing in the United States |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assessing the impact of COVID-19 | Other | Surveying Marshallese adults in the U.S. to determine the impact of COVID-19 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Effects of COVID-19 on Access to Healthcare Services |
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Inclusion Criteria:
Exclusion Criteria:
- Does not meet inclusion criteria
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Self-reported Marshallese persons 18 years of age or older who live in the continental United States or Hawaii.
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| Name | Affiliation | Role |
|---|---|---|
| Pearl A McElfish, PhD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences Northwest | Fayetteville | Arkansas | 72703 | United States |
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Recruitment was open from July 27, 2020 to November 30, 2020. The study was advertised by posting informational flyers on social media. Flyers contained a link to the study information sheet and survey.
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| ID | Title | Description |
|---|---|---|
| FG000 | Marshallese Adults in the U.S. | Marshallese persons 18 years of age or older currently residing in the United States Assessing the impact of COVID-19: Surveying Marshallese adults in the U.S. to determine the impact of COVID-19 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
120 eligible individuals completed at least 10 survey items and were included in the final analytical sample
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| ID | Title | Description |
|---|---|---|
| BG000 | Marshallese Adults in the U.S. | Marshallese persons 18 years of age or older currently residing in the United States Assessing the impact of COVID-19: Surveying Marshallese adults in the U.S. to determine the impact of COVID-19 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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)" | N=117 due to missing data on this item for three participants. | Posted | Count of Participants | Participants | Baseline |
|
Day of survey
This was a one-time cross-sectional survey, so there was no contact with participants prior to, or after the completion of, the survey.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Marshallese Adults in the U.S. | Marshallese persons 18 years of age or older currently residing in the United States Assessing the impact of COVID-19: Surveying Marshallese adults in the U.S. to determine the impact of COVID-19 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pearl A. McElfish | University of Arkansas for Medical Sciences | 479-713-8680 | pamcelfish@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 15, 2020 | Jan 21, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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)". | Posted | Count of Participants | Participants | 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?" | N=119 due to missing data on this item for one participant. | Posted | Count of Participants | Participants | 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)". | Posted | Count of Participants | Participants | 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?" | N=119 due to missing data on this item for one participant. | Posted | Count of Participants | Participants | 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?" | N=119 due to missing data on this item for one participant. | Posted | Count of Participants | Participants | 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?" | N=119 due to missing data on this item for one participant. | Posted | Count of Participants | Participants | 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?" | N=119 due to missing data on this item for one participant. | Posted | Count of Participants | Participants | 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?" | Using survey skip logic, only those participants who selected "yes" to being previously diagnosed with type 2 diabetes were asked this question (n=13). | Posted | Count of Participants | Participants | 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)" | Using survey skip logic, only those participants who selected "yes" to being previously diagnosed with type 2 diabetes were asked this question (n=13). | Posted | Count of Participants | Participants | 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)". | Posted | Count of Participants | Participants | 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)" | Posted | Count of Participants | Participants | 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?" | N=113 due to missing data on this item for seven participants. | Posted | Count of Participants | Participants | 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?" | N=117 due to missing data on this item for three participants. | Posted | Count of Participants | Participants | 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". | N=118 due to missing data on this item for two participants. | Posted | Count of Participants | Participants | 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)". | Posted | Count of Participants | Participants | 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?" | N=119 due to missing data on this item for one participant. | Posted | Count of Participants | Participants | 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)" | Posted | Count of Participants | Participants | Baseline |
|
|
|
| 0 |
| 120 |
| 0 |
| 120 |
| 0 |
| 120 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| Title | Measurements |
|---|---|
|
| Suggested employees wear face masks |
|
| Provided employees with face masks |
|
| Required social distancing at work |
|
| Installed barriers / shields to reduce contact between employees and others |
|
| Taken employee temperatures before entering workplace |
|
| Asked COVID-19 screening questions of employees before entering workplace |
|
| Was tested for COVID-19 |
|
| None of these |
|
| Don't know/Not sure |
|
| Title | Measurements |
|---|
|
| Don't know/Not sure |
|
|
| My healthcare provider told me to self-isolate or quarantine |
|
| None of these apply |
|
| Don't know/Not sure |
|
|
| I have not noticed |
|
| Don't know/Not sure |
|
| Title | Measurements |
|---|
|
| Don't know/Not sure |
|
| Title | Measurements |
|---|
|
| Don't know/Not sure |
|
| Title | Measurements |
|---|---|
|
| I have not noticed |
|
| Don't know/Not sure |
|
| Title | Measurements |
|---|
|
| Don't know/Not sure |
|
| Title | Measurements |
|---|---|
|
| Testing strips |
|
| Other diabetes medication |
|
| No issues to report |
|
| Title | Measurements |
|---|
|
| Yes, at a healthcare clinic or hospital |
|
| Yes, at work |
|
| No |
|
| Don't know/Not sure |
|
| Title | Measurements |
|---|---|
|
| Yes, and I tested negative |
|
| Yes, and I tested positive |
|
| Don't know/Not sure |
|
| Title | Measurements |
|---|---|
|
| Very unlikely |
|
| Don't know/Not sure |
|
| Title | Measurements |
|---|---|
|
| Dr. Sheldon Riklon's radio show or Facebook Live videos |
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| News outlets |
|
| US Dept of Health (CDC, NIH, and other federal health agencies) |
|
| Your state Dept of Health |
|
| Marshallese Consulate/RMI Ministry of Health |
|
| Your pastor |
|
| Other |
|
| None |
|
| Don't know/Not sure |
|
|
| None of these |
|
| Don't know/Not sure |
|
| Title | Measurements |
|---|
|
| I reduced my work hours |
|
| I increased my work hours |
|
| My job put me at increased risk of getting COVID-19 |
|
| I laid off employees |
|
| None of these apply |
|
| Don't know/Not sure |
|
| Title | Measurements |
|---|---|
|
| Don't know/Not sure |
|
| Title | Measurements |
|---|---|
|
| Impact on your child |
|
| Impact on your community |
|
| Impact on family members |
|
| Access to food |
|
| Access to baby supplies (e.g., formula, diapers, wipes) |
|
| Access to personal care products or household supplies |
|
| Access to medical care, including mental health care |
|
| Access to medical supplies (e.g., prescriptions, testing supplies, etc.) |
|
| Social distancing or being quarantined |
|
| Other |
|
| I am not stressed about the COVID-19 outbreak |
|
| Don't know/Not sure |
|