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NCT Number: NCT07622134

Effectiveness of Health Literacy Program for Polypharmacy Patients (HLP-CKD)

This study aims to evaluate the effectiveness of a health literacy promotion program in preventing chronic kidney disease (CKD) among patients who use multiple medications (polypharmacy). Participants will be divided into two groups: an experimental group receiving the health literacy program and a control group receiving standard care. The study will measure improvements in health literacy levels and CKD prevention behaviors over a specific period. It is expected that the program will help patients better manage their medications and reduce the risk of developing kidney complications.

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Key information

Age range

55 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Background: Patients with polypharmacy are at a higher risk of drug-induced kidney injury. Enhancing health literacy is a key strategy to empower these patients to engage in protective health behaviors.

Objectives: 1) To compare health literacy scores before and after participating in the program. 2) To compare CKD prevention behaviors between the experimental and control groups.

Methodology: This is a quasi-experimental study with a pre-test/post-test design.

Experimental Group: Receives the "Health Literacy Promotion Program," which includes educational sessions, skill-building for medication management, and follow-up support.

Control Group: Receives routine nursing care and standard health education. Intervention Details: The program focuses on 6 aspects of health literacy: access, understanding, communication, questioning, decision-making, and practice.

Data Collection: Data will be collected using validated questionnaires for health literacy and CKD prevention behavior at baseline and after the intervention (e.g., at week 12).

Analysis: Descriptive statistics and t-tests (Independent and Paired) will be used to evaluate the program's effectiveness.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 55-74 years diagnosed with non-communicable diseases.
  • Currently taking 5 or more medications daily (Polypharmacy) for at least 6 months.
  • Have at least one risk factor for chronic kidney disease (e.g., Hypertension or Diabetes).
  • Able to communicate, read, and write in Thai.
  • Willing to participate in the 8-week program and follow-up assessments.

Exclusion criteria

  • Patients already diagnosed with Chronic Kidney Disease (CKD) stage 3 - 5.
  • Having severe cognitive impairment or psychiatric disorders that prevent participation.
  • Having severe complications or being in an unstable clinical condition.
  • Planning to move out of the study area during the 12-week study period.

Treatment and study plan

Health Literacy Promotion Program (HLP-CKD)

Behavioral

An 8-week program consisting of educational sessions, skill-building for medication management, and follow-up support to prevent chronic kidney disease.

Primary outcomes

  1. Health Literacy Levels

    Time frame: Baseline, 8 weeks (immediately after intervention), and 12 weeks (follow-up).

    The total score of health literacy regarding chronic kidney disease (CKD) prevention, assessed using a validated Health Literacy Questionnaire. The tool evaluates 6 domains: access, understanding, communication, questioning, decision-making, and practice. Higher scores indicate a higher level of health literacy.

  2. CKD Prevention Behaviors

    Time frame: Baseline, 8 weeks, and 12 weeks.

    The assessment of self-care behaviors to prevent chronic kidney disease, such as medication adherence, dietary control, and physical activity. Evaluated using the CKD Prevention Behavior Scale.

Secondary outcomes

  1. Estimated Glomerular Filtration Rate (eGFR)

    Time frame: Baseline and 12 weeks (follow-up)

    A key indicator of kidney function calculated based on serum creatinine level, age, and sex. It is used to monitor the stage of chronic kidney disease.

  2. Serum Creatinine

    Time frame: Baseline and 12 weeks (follow-up)

    A waste product in the blood that is filtered by the kidneys. This value is used to calculate the eGFR and evaluate kidney health.

  3. Urine Albumin-to-Creatinine Ratio (UACR)

    Time frame: Baseline and 12 weeks (follow-up).

    A marker used to detect albuminuria (protein in the urine), which is an early sign of kidney damage, especially in patients with chronic diseases.

Study contacts

Contact information is provided by the study sponsor or research team.

Wangen Waelveerakup, Dr.P.H.

CONTACT

[email protected]

+66816288879

Wanpen Waelveerakup, Dr.P.H

CONTACT

[email protected]

+66816288879

Sponsors and collaborators

Lead sponsor

Nakhon Pathom Rajabhat University

Other

Registry information

Official study title

Effectiveness of the Health Literacy Promotion Program to Prevent Chronic Kidney Disease of Patients Who Use Polypharmacy

Acronym: HLP-CKD

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 2, 2026
Registry last updated
Jun 4, 2026

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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