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Novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) OR COVID-19 related Addition: The aim of this addition activity is to track the impact of the COVID-19 epidemic on participants with diabetes and chronic kidney disease (CKD). Investigators have modified the original HBKC Study protocol to expand data currently collected from study participants to include data in the following domains linked to the COVID-19 epidemic:
symptoms of COVID-19 disease, access to healthcare, and impact on health related behaviors (such as medication adherence, physical activity, dietary behaviors, smoking, and alcohol use).
Investigators will administer a survey by phone or mail to all participants screened for diabetes and chronic kidney disease in the original HBKC study protocol. The survey will address to the following aims:
Aim 1. Develop a phone-based and or mail based survey to understand the impact of COVID19 on patient-reported outcomes for adults with diabetes and CKD.
Aim 2. Test the feasibility and acceptability of this phone-based and or mail based survey in the HBKC cohort.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Problems in Their Health Care Due to COVID-19 Related Isolation | Document COVID-19 disruptions in normal health care check-ups, transportation, economic status, and access to food and water. | six months |
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Inclusion Criteria:
Exclusion Criteria:
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All Native Americans (n=529) who participated in the screening for diabetes and kidney disease as part of original HBKC study will be approached for this survey based study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
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We recruited 309 participants from 540 individuals who were initially approached by phone and/or mailings from September 2020 to July 2021 to participate in the survey.
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| ID | Title | Description |
|---|---|---|
| FG000 | Covid Survey | COVID-19 Survey. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Group Survey | Survey of the entire group |
| 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 | Number of Participants With Problems in Their Health Care Due to COVID-19 Related Isolation | Document COVID-19 disruptions in normal health care check-ups, transportation, economic status, and access to food and water. | Posted | Count of Participants | Participants | six months |
|
|
6 months
This is a survey of minimum risk.
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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 | Single Group Survey | Single Group Survey | 0 |
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Participant selection bias. The survey instruments have not been fully validated for American Indians.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vallabh Shah, PhD. Principal Investigator | University of New Mexico Health Sciences Center | 505-272-9615 | VShah@salud.unm.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 13, 2021 | Feb 19, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| 309 |
| 0 |
| 309 |
| 0 |
| 309 |
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| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |