Effectiveness of Health Literacy Program for Polypharmacy Patients (HLP-CKD)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-74
SponsorNakhon Pathom Rajabhat University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Health Literacy Promotion Program (HLP-CKD)
BehavioralAn 8-week program consisting of educational sessions, skill-building for medication management, and follow-up support to prevent chronic kidney disease.
Treatment groups
104 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 8 weeks (immediately after intervention), and 12 weeks (follow-up).2
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.
Time frame
Baseline, 8 weeks, and 12 weeks.Secondary outcomes
1
Estimated Glomerular Filtration Rate (eGFR)
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.
Time frame
Baseline and 12 weeks (follow-up)2
Serum Creatinine
A waste product in the blood that is filtered by the kidneys. This value is used to calculate the eGFR and evaluate kidney health.
Time frame
Baseline and 12 weeks (follow-up)3
Urine Albumin-to-Creatinine Ratio (UACR)
A marker used to detect albuminuria (protein in the urine), which is an early sign of kidney damage, especially in patients with chronic diseases.
Time frame
Baseline and 12 weeks (follow-up).Sponsors and contacts
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Source ClinicalTrials.gov
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