NCT04505891

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

August 17, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2021

Completed
Last Updated

January 5, 2022

Status Verified

January 1, 2022

Enrollment Period

1.3 years

First QC Date

August 4, 2020

Last Update Submit

January 3, 2022

Conditions

Keywords

transitions of careeducationpatient reported outcomeschronic kidney diseaseacute kidney injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Brief health literacy screen

    30-days post hospitalization

  • Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10

    30-days post hospitalization

Study Arms (3)

Usual care

NO INTERVENTION

Education alone

ACTIVE COMPARATOR
Behavioral: Education

Education and follow-up

ACTIVE COMPARATOR
Behavioral: Education and follow-up

Interventions

EducationBEHAVIORAL

Kidney health education will be delivered prior to discharge by trained nurse educators.

Education alone

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.

Education and follow-up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • KDIGO Stage 3 AKI
  • Primary care provider at Mayo Rochester.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • May HP, Herges JR, Anderson BK, Hanson GJ, Kashani KB, Kattah AG, Cole KC, McCoy RG, Meade LA, Rule AD, Schreier DJ, Tinaglia AG, Barreto EF; ACT Study Group. Posthospital Multidisciplinary Care for AKI Survivors: A Feasibility Pilot. Kidney Med. 2023 Oct 5;5(12):100734. doi: 10.1016/j.xkme.2023.100734. eCollection 2023 Dec.

Related Links

MeSH Terms

Conditions

Acute Kidney InjuryRenal Insufficiency, Chronic

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Erin F Barreto, PharmD, RPh

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 4, 2020

First Posted

August 10, 2020

Study Start

August 17, 2020

Primary Completion

December 21, 2021

Study Completion

December 21, 2021

Last Updated

January 5, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations