Adherence, Patient, Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis), Structured Education
Conditions
Keywords
Inflammatory bowel disease, Crohn disease, Ulcerative colitis, Anti tumor necrosis factor therapy, Treatment adherence, Patient education, Nurse led patient education, Health Belief Model, Biologic therapy, Chronic disease management, Randomized controlled trial, Health behavior, Medication adherence, Self management, Patient engagement
Brief 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 (\<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.
Detailed description
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.
Interventions
BEHAVIORALHealth Belief Model-Based Structured Patient Education
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.
BEHAVIORALStandard Patient Education
Standard patient education routinely provided in outpatient clinical practice for patients receiving anti-TNF therapy, without a structured theoretical framework.
Sponsors
Izmir Katip Celebi University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants were allocated in parallel to either an intervention group receiving nurse-led, Health Belief Model-based structured patient education or a control group receiving standard education. Participants remained in their assigned groups throughout the study period, and outcomes were assessed using a pre-test/post-test design with follow-up.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-TNF Alpha Treatment Adherence Scale | Baseline (pre-intervention), immediately post-intervention, and 1-month follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Partners in Healthcare Scale | Baseline (pre-intervention), immediately post-intervention, and 1-month follow-up | 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. |
| Patient Satisfaction With Education | Immediately post-intervention | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed