Chronic Kidney DiseasesHLP-CKDNCT07622134
Effectiveness of Health Literacy Program for Polypharmacy Patients (HLP-CKD)
A study testing Health Literacy Promotion Program (HLP-CKD) in people with Chronic Kidney Diseases and Polypharmacy, run by Nakhon Pathom Rajabhat University at 1 site in Thailand.
Trial 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). Read more about this study
- Who is it for?
- Ages 55 to 74 years
- Conditions the study is for
- Chronic Kidney Diseases, Polypharmacy, Health Literacy
- What is being tested?
- Health Literacy Promotion Program (HLP-CKD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteThailand
- Study dates
- 15 Jun 2026to 15 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Health Promoting Hospital
Nakhon Pathom, Changwat Nakhon Pathom, 73000
Wanpen Waelveerakup, Dr.P.H., +66816288879 ext. 0, wanpenw@webmail.npru.ac.th
Wanpen Waelveerakup, Dr.P.H., +66816288879 ext. 0, wanpenw307@gmail.com
About this study
Official title: Effectiveness of the Health Literacy Promotion Program to Prevent Chronic Kidney Disease of Patients Who Use Polypharmacy
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.
Read the 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.
- Conditions
- Chronic Kidney Diseases, Polypharmacy, Health Literacy
- Being tested
- Health Literacy Promotion Program (HLP-CKD)
- Keywords
- Health Literacy Program, CKD Prevention, Medication Management, Nursing Intervention, Randomized Controlled Trial, Thailand
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Literacy Promotion Program (HLP-CKD)Behavioural
An 8-week program consisting of educational sessions, skill-building for medication management, and follow-up support to prevent chronic kidney disease.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Health Literacy Promotion Program (HLP-CKD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 8 weeks, and 12 weeks.
Secondary outcomes (3)
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.
Measured: Baseline and 12 weeks (follow-up)
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.
Measured: Baseline and 12 weeks (follow-up)
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.
Measured: Baseline and 12 weeks (follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nakhon Pathom Rajabhat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wanpen Waelveerakup, Nakhon Pathom Rajabhat University
- Investigators
- Wanpen Waelveerakup, Dr.P.H., Principal investigator, Faculty of Nursing, Nakhon Pathom Rajabhat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622134
- Sponsor's protocol ID
- 009/2026
- Other IDs
- 012/2024
- Acronym
- HLP-CKD
- Status last verified
- May 2026
- First submitted
- 27 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect the privacy and confidentiality of the participants, in accordance with the informed consent and institutional ethical guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Health Literacy Promotion Program to Prevent Chronic Kidney Disease of Patients Who Use Polypharmacy
- ClinicalTrials.gov ID
- NCT07622134
- Acronym / sponsor ID
- HLP-CKD / 009/2026
- Conditions
- Chronic Kidney Diseases, Polypharmacy, Health Literacy
- Keywords
- Health Literacy Program, CKD Prevention, Medication Management, Nursing Intervention, Randomized Controlled Trial, Thailand
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Nakhon Pathom Rajabhat UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: 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 Group | Active comparator | Behavioral: Health Literacy Promotion Program (HLP-CKD)Participants in this group will receive routine nursing care and standard health education provided by the healthcare facility. |
Who may qualify
- Ages
- 55 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Control Group, Experimental Group |
Primary outcome
Health Literacy Levels
Time frame: 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
Time frame: 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.
3 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect the privacy and confidentiality of the participants, in accordance with the informed consent and institutional ethical guidelines.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wanpen Waelveerakup, Dr.P.H. principal investigator
Faculty of Nursing, Nakhon Pathom Rajabhat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Literacy Promotion Program (HLP-CKD) in people with Chronic Kidney Diseases and Polypharmacy, run by Nakhon Pathom Rajabhat University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wangen Waelveerakup, Dr.P.H. (+66816288879 ext. 0, wanpenw@webmail.npru.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Literacy Levels (time frame: Baseline, 8 weeks (immediately after intervention), and 12 weeks (follow-up).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.