Health Literacy 3D Kidney Model Patient Education Trial

Not Applicable

Completed

• Conditions: High Blood Pressure; Kidney Disease, Chronic

• Registration Number: NCT06683573
• Lead Sponsor: Hilary L Surratt, PhD

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-11-08
• Study First Submitted QC: 2024-11-08
• Study First Posted: 2024-11-12
• Status Verified: 2025-01
• Study Start: 2025-02-25
• Primary Completion: 2025-03-27
• Study Completion: 2025-03-27
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in participant confidence for kidney disease management	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.

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States