NCT06683573

Brief Summary

High blood pressure has a different rate effect on many minoritized individuals. African Americans, as a result of high blood pressure, are six times more likely to go through kidney failure compared to white counterparts. Hispanic communities are also disproportionately affected by high blood pressure and, unfortunately, generally have lower knowledge about the effects on the kidneys as well. Unfortunately, many minoritized and underserved communities are affected by the weight of the social determinants of health, i.e., housing, education, food, health care, etc., that contribute to large disparities in health outcomes. These factors lead to poor care management, less ability to manage care effectively, and disengagement from care. Health education is vital to recognizing and communicating with minoritized patients with hypertension-induced chronic renal disease. As the patient's knowledge of the condition grows, this can significantly influence the trust between clinicians and patients. Effective and patient-centered education can inspire patients to be proactive in their prevention strategies with clinicians. This study's overall goal is to assess the utility of a novel patient education tool (3D-printed healthy kidney and diseased kidney models) in optimizing patient education for underserved populations who have hypertension with a potential lead to hypertension-induced chronic renal disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

February 25, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2025

Completed
Last Updated

May 21, 2025

Status Verified

January 1, 2025

Enrollment Period

1 month

First QC Date

November 8, 2024

Last Update Submit

May 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in participant confidence for kidney disease management

    Participant confidence will be measured by a survey with a Likert type scale where higher scores equate to increased confidence.

    Baseline and post intervention, approximately 1 hour

Study Arms (2)

Standard clinical care/TAU

ACTIVE COMPARATOR

standard clinician-led patient education

Behavioral: Standard medical treatment

3D Kidney model enhanced patient education

EXPERIMENTAL

patient education with 3D model

Behavioral: 3D Kidney model

Interventions

3D Kidney modelBEHAVIORAL

Brief provider led counseling and education on Chronic Kidney Disease (CKD) and hypertension guided by use of 3D kidney model visual aid

3D Kidney model enhanced patient education

Standard provider led counseling and education on CKD and hypertension

Standard clinical care/TAU

Eligibility Criteria

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

You may qualify if:

  • Ages 18 and older
  • Seeking medical care in study location
  • Current diagnosis of hypertension and renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

HypertensionRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

  • Hilary L Surratt, PhD

    University of Kentucky

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 8, 2024

First Posted

November 12, 2024

Study Start

February 25, 2025

Primary Completion

March 27, 2025

Study Completion

March 27, 2025

Last Updated

May 21, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations