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Clinical Trials/NCT04520191
NCT04520191CompletedNot Applicable

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

University of New Mexico1 site in 1 country309 target enrollmentStarted: January 4, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
309
Locations
1
Primary Endpoint
Number of Participants With Problems in Their Health Care Due to COVID-19 Related Isolation

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
21 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Number of Participants With Problems in Their Health Care Due to COVID-19 Related Isolation

Time Frame: six months

Document COVID-19 disruptions in normal health care check-ups, transportation, economic status, and access to food and water.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Vallabh O Shah

Professor

University of New Mexico

Study Sites (1)

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