- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07622134
Effectiveness of Health Literacy Program for Polypharmacy Patients (HLP-CKD) (HLP-CKD)
Effectiveness of the Health Literacy Promotion Program to Prevent Chronic Kidney Disease of Patients Who Use Polypharmacy
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Wangen Waelveerakup, Dr.P.H.
- 전화번호: +66816288879
- 이메일: wanpenw@webmail.npru.ac.th
연구 연락처 백업
- 이름: Wanpen Waelveerakup, Dr.P.H
- 전화번호: +66816288879
- 이메일: wanpenw307@gmail.com
연구 장소
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Changwat Nakhon Pathom
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Nakhon Pathom, Changwat Nakhon Pathom, 태국, 73000
- Health Promoting Hospital
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연락하다:
- Wanpen Waelveerakup, Dr.P.H.
- 전화번호: +66816288879
- 이메일: wanpenw@webmail.npru.ac.th
-
연락하다:
- Wanpen Waelveerakup, Dr.P.H.
- 전화번호: +66816288879
- 이메일: wanpenw307@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
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An 8-week program consisting of educational sessions, skill-building for medication management, and follow-up support to prevent chronic kidney disease.
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활성 비교기: Control Group
Participants in this group will receive routine nursing care and standard health education provided by the healthcare facility.
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An 8-week program consisting of educational sessions, skill-building for medication management, and follow-up support to prevent chronic kidney disease.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Health Literacy Levels
기간: Baseline, 8 weeks (immediately after intervention), and 12 weeks (follow-up).
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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.
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Baseline, 8 weeks (immediately after intervention), and 12 weeks (follow-up).
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CKD Prevention Behaviors
기간: Baseline, 8 weeks, and 12 weeks.
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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.
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Baseline, 8 weeks, and 12 weeks.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Estimated Glomerular Filtration Rate (eGFR)
기간: Baseline and 12 weeks (follow-up)
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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.
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Baseline and 12 weeks (follow-up)
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Serum Creatinine
기간: Baseline and 12 weeks (follow-up)
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A waste product in the blood that is filtered by the kidneys.
This value is used to calculate the eGFR and evaluate kidney health.
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Baseline and 12 weeks (follow-up)
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Urine Albumin-to-Creatinine Ratio (UACR)
기간: Baseline and 12 weeks (follow-up).
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A marker used to detect albuminuria (protein in the urine), which is an early sign of kidney damage, especially in patients with chronic diseases.
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Baseline and 12 weeks (follow-up).
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공동 작업자 및 조사자
수사관
- 수석 연구원: Wanpen Waelveerakup, Dr.P.H., Faculty of Nursing, Nakhon Pathom Rajabhat University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 009/2026
- 012/2024 (기타 식별자: Nakhon Pathom Rajabhat University)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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