Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

3. juni 2026 opdateret af: Wanpen Waelveerakup, Nakhon Pathom Rajabhat University

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

104

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Thailand
    • Changwat Nakhon Pathom
      • Nakhon Pathom, Changwat Nakhon Pathom, Thailand, 73000

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Experimental Group
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.
Adfærdsmæssigt: 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.
Aktiv komparator: Control Group
Participants in this group will receive routine nursing care and standard health education provided by the healthcare facility.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Health Literacy Levels
Tidsramme: 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.
Baseline, 8 weeks (immediately after intervention), and 12 weeks (follow-up).
CKD Prevention Behaviors
Tidsramme: 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.
Baseline, 8 weeks, and 12 weeks.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Estimated Glomerular Filtration Rate (eGFR)
Tidsramme: 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.
Baseline and 12 weeks (follow-up)
Serum Creatinine
Tidsramme: 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.
Baseline and 12 weeks (follow-up)
Urine Albumin-to-Creatinine Ratio (UACR)
Tidsramme: 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.
Baseline and 12 weeks (follow-up).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nakhon Pathom Rajabhat University

Efterforskere

  • Ledende efterforsker: Wanpen Waelveerakup, Dr.P.H., Faculty of Nursing, Nakhon Pathom Rajabhat University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. juni 2026

Primær færdiggørelse (Anslået)

15. september 2026

Studieafslutning (Anslået)

15. november 2026

Datoer for studieregistrering

Først indsendt

27. maj 2026

Først indsendt, der opfyldte QC-kriterier

27. maj 2026

Først opslået (Faktiske)

2. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 009/2026
  • 012/2024 (Anden identifikator: Nakhon Pathom Rajabhat University)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner