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OpenTrials
Completed

NCT Number: NCT06683573

Health Literacy 3D Kidney Model Patient Education Trial

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.

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Key information

Conditions

High Blood Pressure Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Kidney Disease, Chronic Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

About this study

The overall Aims of the study are to:

Aim 1: Examine the feasibility of creating a high-quality life-size 3D reconstruction of a healthy kidney model and diseased kidney model through collaboration with NIH 3D print exchange and the University of Kentucky College of Engineering.

Aim 2: Assess the acceptability and preliminary efficacy of 3D print model-supported patient education in improving the patients' medical understanding, motivation for self-care, intention to adhere to the clinician's instructions, and better trust between clinician and patient.

Aim 3: Continuously implement of 3D-printed models for patients in new or current care education so that it can be sustainable after the research project is concluded.

To achieve Aim 2, up to 100 patients with hypertension-induced chronic renal disease will be enrolled and randomized to receive either standard clinician-led patient education (TAU) or patient education employing the 3D kidney model. A brief pre-post structured survey will be implemented to measure changes in patients' understanding of their condition, as well as acceptability of the 3D model for those assigned to the experimental education condition.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

3D Kidney model

Behavioral

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

Standard medical treatment

Behavioral

Standard provider led counseling and education on CKD and hypertension

Primary outcomes

  1. Change in participant confidence for kidney disease management

    Time frame: Baseline and post intervention, approximately 1 hour

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

Sponsors and collaborators

Lead sponsor

Hilary L Surratt, PhD

Other

Collaborators

  • University of Kentucky

Registry information

Official study title

Optimizing Health Literacy and Disease Management Through 3D Kidney Model: Innovative Patient Education Approaches for Underserved Patients Impacted by Social Determinants of Health

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 12, 2024
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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