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Completed
NCT07652840
Treatment Adherence Among Patients With Inflammatory Bowel Disease Receiving Anti-TNF Therapy
Conditions: Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis), Adherence, Patient, Structured Education
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 140
Sponsor: Izmir Katip Celebi University
Location: Izmir Ekonomi University Medical Point Hospital Izmir
Summary
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 (\
Eligibility Criteria
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)
Source: ClinicalTrials.gov (NCT07652840). StuddyBuddy aggregates publicly available trial information.