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

NCT07622134 — Not applicable, Not yet recruiting, 104 participants, Nakhon Pathom Rajabhat University

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

RegistryNCT07622134, acronym HLP-CKD
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, prevention
Enrollment104 (Estimated)
SponsorNakhon Pathom Rajabhat University (Other)
ConditionsChronic Kidney Diseases, Polypharmacy, Health Literacy
InterventionsHealth Literacy Promotion Program (HLP-CKD) (Behavioral)
Datesstart 2026-06-15 (estimated), primary completion 2026-09-15 (estimated), completion 2026-11-15 (estimated), first posted 2026-06-02, last updated 2026-06-04
Locations1 site in Thailand

Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Kidney Diseases All trials for Polypharmacy All trials of Health Literacy Promotion Program (HLP-CKD)

-Summary

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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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Experimental GroupExperimentalBehavioral: Health Literacy Promotion Program (HLP-CKD)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.
Control GroupActive comparatorBehavioral: Health Literacy Promotion Program (HLP-CKD)Participants in this group will receive routine nursing care and standard health education provided by the healthcare facility.
  • 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.

+Outcome measures

Primary outcomes

  • Health Literacy Levels [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.
  • CKD Prevention Behaviors [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

  • Estimated Glomerular Filtration Rate (eGFR) [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.
  • Serum Creatinine [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.
  • Urine Albumin-to-Creatinine Ratio (UACR) [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.

+Eligibility

Sex: All, ages: 55 Years to 74 Years

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.

+Locations (1)

FacilityCityCountryStatus
Health Promoting HospitalNakhon Pathom, Changwat Nakhon PathomThailand

+Investigators