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NCT04520191 Clinical Trial

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

CKD Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04520191
Other study ID # 16-344-Enhancement
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 4, 2021
Est. completion date August 30, 2024

Study information
Verified date January 2024
Source University of New Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 309
Est. completion date August 30, 2024
Est. primary completion date August 30, 2024
Accepts healthy volunteers
Gender All
Age group 21 Years to 80 Years
Eligibility Inclusion Criteria: - Willingness to participate in the phone-based and or mail based survey. Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of New Mexico Albuquerque New Mexico

Sponsors (1)
Lead Sponsor Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
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. six months
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