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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04505891
Other study ID # 20-004204
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 17, 2020
Est. completion date December 21, 2021

Study information

Verified date January 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the ability of education and outpatient kidney care follow-up in order to improve patient knowledge about acute kidney injury (AKI).


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date December 21, 2021
Est. primary completion date December 21, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - KDIGO Stage 3 AKI - Primary care provider at Mayo Rochester. Exclusion Criteria: - Patient with need for dialysis at discharge from hospital or hospice. - Enrolled in the Primary Care Transition Program. - Non-English speaking. - Cognitive impairment. - Dementia. - Mini-Cog score of less than 3.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Education
Kidney health education will be delivered prior to discharge by trained nurse educators.
Education and follow-up
In patients allocated to the education and follow-up arm, education along with a a post-discharge healthcare visit from a multidisciplinary care team will be performed.

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Modified Kidney Knowledge Survey (mKIKS) Assesses participants' objective knowledge about AKI causes, risk factors, and management. The minimum score is 0, maximum score is 15, higher scores indicate greater knowledge. 14-days after last study contact
Secondary Brief health literacy screen A 4-item tool to assess health literacy. Minimum score of 0, maximum score 20, higher scores indicate higher health literacy 30-days post hospitalization
Secondary Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10 Based on the provided responses, an overall summary score, and two subset scores - Global health physical and Global health mental can be calculated. Raw summed score are converted into T-scores. Higher scores indicate better health. 30-days post hospitalization
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