CKDNCT04520191
Home-based Kidney Care in Native Americans of New Mexico (HBKC) - Enhancement: COVID-19 Study
An observational study of CKD, run by University of New Mexico at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- CKD
- How many people
- 309 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2021to 1 Aug 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Willingness to participate in the phone-based and or mail based survey.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
Official title: Home-based Kidney Care in Native Americans of New Mexico (HBKC) - COVID-19 Related Disruption in Health and Health Care
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).
Read the 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.
- Conditions
- CKD
- Keywords
- CKD, Diabetes, Ameircan Indians, COVID-19,
- Medical subject headings
- Diabetes Mellitus, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start4 Jan 2021
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CKDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vallabh O Shah, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520191
- Sponsor's protocol ID
- 16-344-Enhancement
- Status last verified
- Feb 2025
- First submitted
- 17 Aug 2020
- Last updated
- 4 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Kidney Care in Native Americans of New Mexico (HBKC) - COVID-19 Related Disruption in Health and Health Care
- ClinicalTrials.gov ID
- NCT04520191
- Acronym / sponsor ID
- 16-344-Enhancement
- Conditions
- CKD
- Keywords
- CKD, Diabetes, Ameircan Indians, COVID-19,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 20 Aug 2020 (actual)
- Results
- Posted 4 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Willingness to participate in the phone-based and or mail based survey.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CKD, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Problems in Their Health Care Due to COVID-19 Related Isolation (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.