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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Izmir, Turquía (Türkiye)
- Izmir Ekonomi University Medical Point Hospital
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Izmir, Turquía (Türkiye)
- Izmir Ataturk Training and Research Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Anti-TNF Alpha Treatment Adherence Scale
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Partners in Healthcare Scale
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- Ensayo controlado aleatorizado
- Adherencia a la medicación
- Educación del paciente
- Colitis ulcerosa
- Enfermedad inflamatoria intestinal
- Enfermedad de Crohn
- Modelo de creencias sobre la salud
- Adherencia al tratamiento
- Comportamiento de salud
- Compromiso del paciente
- Manejo de enfermedades crónicas
- Autogestión
- Terapia biológica
- Anti tumor necrosis factor therapy
- Nurse led patient education
Términos MeSH relevantes adicionales
- Enfermedades intestinales
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades del Colon
- Gastroenteritis
- Colitis
- Comportamiento
- Aceptación del paciente de la atención médica
- Colitis Ulcerativa
- Enfermedad de Crohn
- Enfermedades inflamatorias del intestino
- Comportamiento de salud
- Adherencia a la medicación
- Participación del paciente
- Adherencia y Cumplimiento del Tratamiento
- Cumplimiento del paciente
Otros números de identificación del estudio
- 0588
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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