Treatment Adherence Among Patients With Inflammatory Bowel Disease Receiving Anti-TNF Therapy
Effect of Health Belief Model-Based Nurse-Led Patient Education on Treatment Adherence Among Patients With Inflammatory Bowel Disease Receiving Anti-Tumor Necrosis Factor Therapy
Inflammatory bowel disease (IBD) is a chronic condition characterized by periods of remission and relapse, requiring long-term treatment adherence to maintain disease control and prevent complications. Anti-tumor necrosis factor (anti-TNF) agents are widely used in the management of moderate to severe IBD; however, suboptimal adherence remains a significant clinical problem due to concerns related to adverse effects, treatment burden, and insufficient patient knowledge.
This randomized controlled trial evaluated the effectiveness of a nurse-led, Health Belief Model (HBM)-based structured patient education program on treatment adherence among patients with inflammatory bowel disease (IBD) receiving anti-TNF-α therapy. The study was conducted as a two-center trial between February and July 2024 in the gastroenterology inpatient units and outpatient clinics in Izmir, Turkey.
A total of 408 patients were screened, and 140 eligible patients were enrolled and allocated 1:1 to intervention (n=70) and control (n=70) groups.
Participants were randomized using stratified randomization to balance potential confounders, with strata defined by sex, age group (18-35, 36-54, ≥55), IBD type (ulcerative colitis/Crohn's disease), IBD diagnosis duration (<12, 13-24, 25-36 months), and anti-TNF treatment duration (<6, 6-12, 13-36 months). Assignments were generated via SPSS with a fixed block size within strata.
Eligible participants were adults (≥18 years), Turkish-literate, diagnosed with IBD for ≥6 months, using anti-TNF-α therapy for ≥3 months, able to communicate and cognitively competent, and willing to participate. Key exclusions included cognitive disorders (e.g., dementia/Alzheimer's), malignant/pre-malignant disease history, and use of more than four medications.
The intervention group received the HBM-based structured education, while the control group received standard education. Outcomes were assessed using a pre-test/post-test design to determine the program's impact on adherence-related measures.
연구 개요
상태
상세 설명
This study was designed as a randomized controlled trial to evaluate the effect of a nurse-led, structured patient education program based on the Health Belief Model on treatment adherence among patients receiving anti-TNF therapy. The study was conducted in two tertiary care hospitals in Türkiye between February and July 2024.
Eligible participants were allocated in a 1:1 ratio to either an intervention group or a control group using stratified randomization. Stratification variables included demographic and disease-related characteristics to ensure balance between study arms. Randomization sequences were generated using a computer-based randomization procedure.
Participants in the intervention group received a structured patient education program delivered by trained nurses and grounded in the constructs of the Health Belief Model, focusing on adherence-related beliefs, perceived benefits and barriers, and self-management of anti-TNF therapy. Participants in the control group received standard education routinely provided in outpatient clinical practice.
The study followed a pre-test/post-test design with follow-up assessment to evaluate changes over time. Outcome assessments were conducted at baseline, immediately after the intervention, and at follow-up. The effectiveness of the intervention was evaluated by comparing adherence-related outcomes between the intervention and control groups over time.
This trial aimed to contribute evidence on the role of theory-based, nurse-led patient education in supporting treatment adherence among patients receiving biologic therapies.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Izmir, 터키 (Türkiye)
- Izmir Ekonomi University Medical Point Hospital
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Izmir, 터키 (Türkiye)
- İzmir Atatürk Training and Research Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Aged 18 years or older
- Diagnosed with inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- Diagnosed with inflammatory bowel disease for at least 6 months
- Receiving anti-TNF-α therapy for at least 3 months
- Able to read and write in Turkish
- Able to communicate effectively
- Cognitively competent
- Provided written informed consent and agreed to participate in the study
Exclusion Criteria:
- Presence of cognitive disorders that may impair understanding or decision-making (e.g., dementia, Alzheimer's disease)
- History of malignant or premalignant disease
- Use of more than four concurrent medications (e.g., medications for hypertension, diabetes, cancer, or hematologic diseases)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Health Belief Model-Based Structured Patient Education
Participants received a nurse-led, structured patient education program grounded in the Health Belief Model to support adherence to anti-TNF therapy and treatment self-management in inflammatory bowel disease.
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A nurse-led structured patient education program based on the Health Belief Model, targeting adherence-related beliefs and behaviors for anti-TNF therapy, including education on medication use and addressing concerns and barriers to adherence.
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활성 비교기: Standard Education
Participants received standard outpatient clinic education routinely provided as part of usual care for patients receiving anti-TNF therapy.
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Standard patient education routinely provided in outpatient clinical practice for patients receiving anti-TNF therapy, without a structured theoretical framework.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Anti-TNF Alpha Treatment Adherence Scale
기간: Baseline (pre-intervention), immediately post-intervention, and 1-month follow-up
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Treatment adherence was measured using the Anti-TNF Alpha Treatment Adherence Scale, a validated self-report instrument assessing patients' adherence behaviors related to anti-TNF therapy.
The scale evaluates multiple domains including medication-taking behavior, concerns about treatment, perceived barriers, and factors influencing continuation or discontinuation of therapy.
Higher scores indicate better adherence to anti-TNF treatment.
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Baseline (pre-intervention), immediately post-intervention, and 1-month follow-up
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Partners in Healthcare Scale
기간: Baseline (pre-intervention), immediately post-intervention, and 1-month follow-up
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Nurse-patient collaboration was assessed using the Partners in Healthcare Scale-Turkish (PIH-TR), which measures the degree of cooperation, shared decision-making, and partnership between patients and healthcare professionals in disease management.
Higher scores reflect stronger collaboration.
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Baseline (pre-intervention), immediately post-intervention, and 1-month follow-up
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Patient Satisfaction With Education
기간: Immediately post-intervention
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Patient satisfaction with the education received was measured using the The Psychometric Assessment on Patient Educationn Scale, a validated instrument evaluating patients' perceptions of the clarity, usefulness, and adequacy of the educational intervention provided during the study.
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Immediately post-intervention
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Sullivan GM, Feinn R. Using Effect Size-or Why the P Value Is Not Enough. J Grad Med Educ. 2012 Sep;4(3):279-82. doi: 10.4300/JGME-D-12-00156.1. No abstract available.
- Cummings KM, Jette AM, Rosenstock IM. Construct validation of the health belief model. Health Educ Monogr. 1978 Winter;6(4):394-405. doi: 10.1177/109019817800600406.
- Ciftci B, Avsar G, Sarialioglu A. A psychometric assessment on patient education: Developing a satisfaction scale. Perspect Psychiatr Care. 2022 Oct;58(4):2237-2245. doi: 10.1111/ppc.13052. Epub 2022 Feb 16.
- Basak N, Ozgursoy Uran BN, Saritas Yuksel E. Treatment Adherence of Anti-TNF Drugs in the Patients with Inflammatory Bowel Disease: A Scale Development Study. Turk J Gastroenterol. 2022 Apr;33(4):336-345. doi: 10.5152/tjg.2022.211170.
- King K, Czuber-Dochan W, Chalder T, Norton C. Medication Non-Adherence in Inflammatory Bowel Disease: A Systematic Review Identifying Risk Factors and Opportunities for Intervention. Pharmacy (Basel). 2025 Feb 7;13(1):21. doi: 10.3390/pharmacy13010021.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 0588
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
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