NCT04119570

Brief Summary

The investigators will study physician-patient communication at the UCMC nephrology fellow clinic and to test an intervention, the CKD Report Card, to improve that communication and patient knowledge of CKD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

May 15, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 17, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 8, 2019

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

September 17, 2019

Last Update Submit

May 3, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • CKD Knowledge

    Kidney Disease Knowledge Survey (KiKs)

    Change in CKD Knowledge from Baseline (pre-visit) to CKD Knowledge immediately post clinic visit (within 15-100 minutes post-clinic visit)

Secondary Outcomes (2)

  • patient-physician interaction

    immediately post-nephrology clinic visit (on day of enrollment, within 15-100 minutes post-clinic visit)

  • communication assessment

    immediately post-nephrology clinic visit (on day of enrollment, within 15-100 minutes post-clinic visit)

Study Arms (2)

No intervention

NO INTERVENTION

Participants will have their clinic visit as per usual care.

CKD Report Card

ACTIVE COMPARATOR

Participants will receive the CKD Report Card prior to the clinic visit.

Behavioral: CKD Report Card

Interventions

CKD Report CardBEHAVIORAL

The CKD Report Card is a handout based on a NKDEP Educational Sheet that includes basic information about kidney disease and spaces where patient can record information about their own kidney disease

CKD Report Card

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English-speaking adult patients (age 18 or older)
  • Identified in the medical record as non-Hispanic Black or non- Hispanic White
  • seen in University of Chicago nephrology clinic with a participating nephrologist

You may not qualify if:

  • not able to communicate in English
  • lacking ability to consent to study
  • does not identify as non-Hispanic Black or non-Hispanic
  • without chronic kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Study Officials

  • Milda R. Saunders, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: During the first half of the study, participants will be surveyed and observed without the intervention. During the second half, participants will be surveyed and observed with the intervention (CKD Report Card)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2019

First Posted

October 8, 2019

Study Start

May 15, 2018

Primary Completion

September 15, 2018

Study Completion

September 15, 2018

Last Updated

May 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations