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Not yet recruiting NCT07622134

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

No phase Interventional Chronic Kidney Diseases Polypharmacy Health Literacy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Health Literacy Promotion Program (HLP-CKD).
Who it may be relevant to
Registry conditions: Chronic Kidney Diseases, Polypharmacy, Health Literacy. Basic parameters: 55 years — 74 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Health Literacy Levels [Time frame: Baseline, 8 weeks (immediately after intervention), and 12 weeks (follow-up).]
  • CKD Prevention Behaviors [Time frame: Baseline, 8 weeks, and 12 weeks.]
Secondary outcome measures (3)
  • Estimated Glomerular Filtration Rate (eGFR) [Time frame: Baseline and 12 weeks (follow-up)]
  • Serum Creatinine [Time frame: Baseline and 12 weeks (follow-up)]
  • Urine Albumin-to-Creatinine Ratio (UACR) [Time frame: Baseline and 12 weeks (follow-up).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Thailand · 1 center
  • Health Promoting Hospital — Nakhon Pathom

Identifiers

NCT: NCT07622134 · 009/2026 · 012/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗