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Home-based Kidney Care in Native Americans of New Mexico (HBKC) - Enhancement: COVID-19 Study

Home-based Kidney Care in Native Americans of New Mexico (HBKC) - COVID-19 Related Disruption in Health and Health Care

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04520191
Enrollment
309
Registered
2020-08-20
Start date
2021-01-04
Completion date
2024-08-01
Last updated
2025-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CKD

Keywords

CKD, Diabetes, Ameircan Indians, COVID-19,

Brief summary

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).

Detailed description

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.

Interventions

None listed

Sponsors

University of New Mexico
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 80 Years

Inclusion criteria

* Willingness to participate in the phone-based and or mail based survey.

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Problems in Their Health Care Due to COVID-19 Related Isolationsix monthsDocument COVID-19 disruptions in normal health care check-ups, transportation, economic status, and access to food and water.

Countries

United States

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
Single Group Survey
Survey of the entire group
309
Total309

Baseline characteristics

CharacteristicSingle Group Survey
Age, Continuous57.6 years
STANDARD_DEVIATION 14.8
Race (NIH/OMB)
American Indian or Alaska Native
309 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
0 Participants
Sex: Female, Male
Female
197 Participants
Sex: Female, Male
Male
112 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 309
other
Total, other adverse events
0 / 309
serious
Total, serious adverse events
0 / 309

Outcome results

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.

Time frame: six months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
COVID SurveyNumber of Participants With Problems in Their Health Care Due to COVID-19 Related Isolation155 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026