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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Izmir、トルコ（Türkiye）
- Izmir Ekonomi University Medical Point Hospital
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Izmir、トルコ（Türkiye）
- Izmir Ataturk Training and Research Hospital
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Anti-TNF Alpha Treatment Adherence Scale
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Partners in Healthcare Scale
時間枠：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
時間枠：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.
|
Immediately post-intervention
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 0588
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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