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

NCT04520191 | Completed Results

• 1 other identifier: 16-344-Enhancement
• Study Type: observational
• Target: 309
• Locations: 1 country
• Sites: 1

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).

Conditions

CKD

Keywords

CKD, Diabetes, Ameircan Indians, COVID-19,

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; COVID-19

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

Participant selection bias. The survey instruments have not been fully validated for American Indians.

Results Point of Contact

• Title: Vallabh Shah, PhD. Principal Investigator
• Organization: University of New Mexico Health Sciences Center

VShah@salud.unm.edu

505-272-9615

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 20, 2020
• Study Start: January 4, 2021
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: March 4, 2025
• Results First Posted: March 4, 2025

Record last verified: 2025-02

Locations

US (1)