Chronic Kidney Diseases, Health Literacy, Polypharmacy
Conditions
Keywords
Health Literacy Program, CKD Prevention, Medication Management, Nursing Intervention, Randomized Controlled Trial, Thailand
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.
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
BEHAVIORALHealth 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.
Sponsors
Nakhon Pathom Rajabhat University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessor, who is responsible for data collection and evaluation, is blinded to the group assignment to minimize assessment bias.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
55 Years to 74 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Thailand
Contacts
CONTACTWangen Waelveerakup, Dr.P.H.
CONTACTWanpen Waelveerakup, Dr.P.H
PRINCIPAL_INVESTIGATORWanpen Waelveerakup, Dr.P.H.
Faculty of Nursing, Nakhon Pathom Rajabhat University
Outcome results
None listed