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

NCT07622134 | Not Yet Recruiting

• 2 other identifiers: 009/2026012/2024
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Diseases; Polypharmacy; Health Literacy

Keywords

Health Literacy Program; CKD Prevention; Medication Management; Nursing Intervention; Randomized Controlled Trial; Thailand

Outcome Measures

Primary Outcomes (2)

• Health Literacy Levels

  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

  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 Outcomes (3)

• Estimated Glomerular Filtration Rate (eGFR)

  Baseline and 12 weeks (follow-up)

• Serum Creatinine

  Baseline and 12 weeks (follow-up)

• Urine Albumin-to-Creatinine Ratio (UACR)

  Baseline and 12 weeks (follow-up).

Study Arms (2)

Experimental Group

EXPERIMENTAL

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)

Control Group

ACTIVE COMPARATOR

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)

Interventions

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.

Control Group; Experimental Group

Eligibility Criteria

• Age: 55 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nakhon Pathom Rajabhat University: lead

Study Sites (1)

Health Promoting Hospital

Nakhon Pathom, Changwat Nakhon Pathom, 73000, Thailand

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wanpen Waelveerakup, Dr.P.H.

  Faculty of Nursing, Nakhon Pathom Rajabhat University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wangen Waelveerakup, Dr.P.H.

CONTACT

+66816288879; wanpenw@webmail.npru.ac.th

Wanpen Waelveerakup, Dr.P.H

CONTACT

+66816288879; wanpenw307@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor, who is responsible for data collection and evaluation, is blinded to the group assignment to minimize assessment bias.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The study is a randomized controlled trial (RCT) with a parallel-group design and a 1:1 allocation ratio. Participants are randomly assigned using computer-generated random numbers. The study procedure is divided into three phases: Baseline assessment (Pre-test) before the intervention. Intervention phase: The experimental group receives an 8-week health literacy promotion program, while the control group receives standard care. Post-intervention evaluation is conducted immediately after the program ends. Follow-up phase: A follow-up assessment is performed at 12 weeks to evaluate the long-term effectiveness of the program.

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)