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

June 3, 2026 updated by: Wanpen Waelveerakup, Nakhon Pathom Rajabhat University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
    • Changwat Nakhon Pathom
      • Nakhon Pathom, Changwat Nakhon Pathom, Thailand, 73000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Participants in this group will receive the 8-week Health Literacy Promotion Program (HLP-CKD), which includes educational sessions, skill-building for medication management, and follow-up support.
Behavioral: Health Literacy Promotion Program (HLP-CKD)
An 8-week program consisting of educational sessions, skill-building for medication management, and follow-up support to prevent chronic kidney disease.
Active Comparator: Control Group
Participants in this group will receive routine nursing care and standard health education provided by the healthcare facility.
Behavioral: Health Literacy Promotion Program (HLP-CKD)
An 8-week program consisting of educational sessions, skill-building for medication management, and follow-up support to prevent chronic kidney disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 8 weeks (immediately after intervention), and 12 weeks (follow-up).
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.
Baseline, 8 weeks, and 12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12 weeks (follow-up)
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.
Baseline and 12 weeks (follow-up)
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.
Baseline and 12 weeks (follow-up).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nakhon Pathom Rajabhat University

Investigators

  • Principal Investigator: Wanpen Waelveerakup, Dr.P.H., Faculty of Nursing, Nakhon Pathom Rajabhat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

November 15, 2026

Study Registration Dates

First Submitted

May 27, 2026

First Submitted That Met QC Criteria

May 27, 2026

First Posted (Actual)

June 2, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 009/2026
  • 012/2024 (Other Identifier: Nakhon Pathom Rajabhat University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared to protect the privacy and confidentiality of the participants, in accordance with the informed consent and institutional ethical guidelines.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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