Treatment Adherence Among Patients With Inflammatory Bowel Disease Receiving Anti-TNF Therapy

Overview

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.

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.