Effectiveness of a Structured Educational Program on Pain Intensity, Self-Efficacy, Foot Self-Care Behaviors, and Health-Related Quality of Life Among Adults With Diabetic Foot (DF-EDU-RCT)
Effectiveness of a Structured Educational Program on Pain Intensity, Self-Efficacy, Foot Self-Care Behaviors, and Health-Related Quality of Life Among Adults With Diabetic Foot: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effectiveness of a structured educational program on pain intensity, self-efficacy, foot self-care behaviors, and health-related quality of life among adults with diabetic foot. Diabetic foot complications are a major cause of morbidity, reduced quality of life, and disability among patients with diabetes mellitus. Poor self-care practices and inadequate knowledge contribute significantly to the progression of foot ulcers and related complications.
Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive a structured educational program designed to improve knowledge, self-management skills, and adherence to recommended diabetic foot care practices. The control group will receive routine care provided by the healthcare facility.
The educational program focuses on key areas including foot hygiene, daily foot inspection, appropriate footwear, glycemic control, and early identification of warning signs of complications. The primary outcomes of the study include changes in pain intensity, self-efficacy, foot self-care behaviors, and health-related quality of life, which will be assessed at baseline and after the intervention period.
The findings of this study are expected to contribute to improving nursing educational interventions and enhancing self-management outcomes among patients with diabetic foot.
연구 개요
상세 설명
Diabetic foot is one of the most serious and common complications of diabetes mellitus, often leading to infection, ulceration, hospitalization, and in severe cases, lower limb amputation. It significantly affects patients' physical, psychological, and social well-being, thereby reducing overall quality of life. Despite the availability of preventive guidelines, many patients continue to demonstrate inadequate foot self-care behaviors, poor adherence to management recommendations, and low self-efficacy in managing their condition.
This study is designed as a randomized controlled trial to assess the effectiveness of a structured educational program on improving clinical and behavioral outcomes among adults with diabetic foot. The study will be conducted at selected healthcare settings, and eligible participants will be randomly allocated into either an intervention group or a control group using a predefined randomization method.
The intervention group will receive a structured educational program delivered through planned teaching sessions. The program is based on evidence-based diabetic foot care guidelines and includes theoretical and practical components. Topics covered include diabetic foot anatomy and risk factors, daily foot inspection techniques, proper hygiene practices, nail and skin care, appropriate footwear selection, wound prevention strategies, glycemic control, and early recognition of complications. Educational materials such as brochures, demonstrations, and interactive discussions will be used to enhance understanding and adherence.
The control group will receive routine care and standard education provided by the healthcare facility without additional structured intervention.
Outcome measures will be assessed at baseline and post-intervention. The primary outcomes include:
Pain intensity measured using a validated pain scale Self-efficacy assessed through a standardized self-efficacy instrument Foot self-care behaviors measured using a diabetic foot care behavior scale Health-related quality of life assessed using a validated quality of life questionnaire
Data will be analyzed to determine the effectiveness of the structured educational program in improving these outcomes compared to routine care.
The study is expected to provide evidence supporting the integration of structured educational programs into nursing practice to improve self-management, reduce complications, and enhance quality of life among patients with diabetic foot.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr
- 전화번호: +962779084560
- 이메일: JAWAD_0799@YAHOO.COM
연구 장소
-
-
Dours
-
Jerash, Dours, 요르단, 009627
- Ministry of Health Primary Healthcare Centers
-
연락하다:
- Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr
- 전화번호: 0779084560
- 이메일: JAWAD_0799@YAHOO.COM
-
연락하다:
- 이메일: JAWAD_0799@YAHOO.COM
-
수석 연구원:
- Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults aged 18 years and older
- Diagnosed with diabetic foot
- Able to communicate effectively
- Willing to participate in the educational program
- Able to provide written informed consent
Exclusion Criteria:
- Patients with severe or unstable medical conditions (e.g., advanced heart failure, renal failure, or active infections) that may interfere with participation
- Patients with major lower-limb amputation or severe foot deformities preventing participation in the educational program or assessments
- Patients with cognitive impairments, psychiatric disorders, or communication difficulties affecting understanding or compliance
- Pregnant or lactating women
- Patients who refuse to provide informed consent or withdraw at any stage of the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 대조군
|
A structured educational program designed for adults with diabetic foot to improve self-care practices and disease management.
The program includes planned teaching sessions delivered by trained nursing staff and covers key topics such as foot hygiene, daily foot inspection, proper nail and skin care, appropriate footwear selection, glycemic control, and early identification of complications.
Educational strategies include lectures, demonstrations, printed materials, and interactive discussions to enhance participants' knowledge, self-efficacy, and adherence to recommended foot care behaviors.
|
|
실험적: Educational Program Group
|
A structured educational program designed for adults with diabetic foot to improve self-care practices and disease management.
The program includes planned teaching sessions delivered by trained nursing staff and covers key topics such as foot hygiene, daily foot inspection, proper nail and skin care, appropriate footwear selection, glycemic control, and early identification of complications.
Educational strategies include lectures, demonstrations, printed materials, and interactive discussions to enhance participants' knowledge, self-efficacy, and adherence to recommended foot care behaviors.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pain Intensity Measured Using the Numeric Rating Scale (NRS)
기간: Baseline and post-intervention (4-8 weeks).
|
Change in pain intensity measured using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain.
Higher scores indicate greater pain intensity.
|
Baseline and post-intervention (4-8 weeks).
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Diabetes Self-Efficacy Measured Using the Diabetes Self-Efficacy Scale (DSES)
기간: Baseline and post-intervention (4-8 weeks).
|
Change in diabetes self-efficacy measured using the Diabetes Self-Efficacy Scale (DSES).
The scale consists of 8 items assessing patients' confidence in managing diabetes-related self-care behaviors.
Each item is rated on a 5-point Likert scale ranging from 1 (not at all confident) to 5 (very confident).
Total scores range from 8 to 40, with higher scores indicating higher self-efficacy.
|
Baseline and post-intervention (4-8 weeks).
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Foot Self-Care Behaviors Measured Using the Diabetic Foot Self-Care Questionnaire (DFSQ-UMA-En)
기간: Baseline and post-intervention (4-8 weeks).
|
Change in foot self-care behaviors measured using the Diabetic Foot Self-Care Questionnaire (DFSQ-UMA-En).
The instrument is a validated 16-item self-report questionnaire developed to assess self-care behaviors among patients with diabetes.
It includes three domains: foot self-care, self-examination, and footwear/sock management.
Items are rated on a Likert scale, and higher scores indicate poorer foot self-care behaviors.
|
Baseline and post-intervention (4-8 weeks).
|
|
Health-Related Quality of Life Measured Using the EQ-5D-5L Questionnaire
기간: Baseline and post-intervention (4-8 weeks).
|
Change in health-related quality of life measured using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire.
The EQ-5D-5L includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on a 5-level scale ranging from no problems to extreme problems.
The EQ-5D index score typically ranges from values below 0 (worse than death) to 1 (full health), where higher scores indicate better health-related quality of life.
Additionally, overall health status is assessed using the EQ Visual Analog Scale (EQ-VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health).
|
Baseline and post-intervention (4-8 weeks).
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Jawad AHMAD Ahmed, Asst.Prof.Dr, Jerash University, Faculty of Nursing
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
- DF-EDU-RCT-2026
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
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Structured Educational Program에 대한 임상 시험
-
University Hospitals of North Midlands NHS TrustPneumacare Ltd완전한
-
Children's Hospital Medical Center, CincinnatiNational Institute of Mental Health (NIMH)완전한
-
Chang Gung University of Science and Technology아직 모집하지 않음
-
AdventHealthState of Florida Department of Health모병
-
Hong Kong Metropolitan University아직 모집하지 않음간호 교육 교육학 | 대화 AI 간호 교육 심각한 게임
-
University of Texas Southwestern Medical CenterNational Institute on Minority Health and Health Disparities (NIMHD)초대로 등록
-
University of LiverpoolLondon School of Hygiene and Tropical Medicine; National Institute of Mental Health (NIMH)완전한