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

NCT07652840 | Completed

• 1 other identifier: 0588
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

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.

Conditions

Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis); Adherence, Patient; Structured Education

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

Outcome Measures

Primary Outcomes (1)

• Anti-TNF Alpha Treatment Adherence Scale

  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.

  Baseline (pre-intervention), immediately post-intervention, and 1-month follow-up

Secondary Outcomes (2)

• Partners in Healthcare Scale

  Baseline (pre-intervention), immediately post-intervention, and 1-month follow-up

• Patient Satisfaction With Education

  Immediately post-intervention

Study Arms (2)

Health Belief Model-Based Structured Patient Education

EXPERIMENTAL

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.

Behavioral: Health Belief Model-Based Structured Patient Education

Standard Education

ACTIVE COMPARATOR

Participants received standard outpatient clinic education routinely provided as part of usual care for patients receiving anti-TNF therapy.

Behavioral: Standard Patient Education

Interventions

Health Belief Model-Based Structured Patient Education BEHAVIORAL

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.

Health Belief Model-Based Structured Patient Education

Standard Patient Education BEHAVIORAL

Standard patient education routinely provided in outpatient clinical practice for patients receiving anti-TNF therapy, without a structured theoretical framework.

Standard Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (2)

Izmir Ekonomi University Medical Point Hospital

Izmir, Turkey (Türkiye)

Location

İzmir Atatürk Training and Research Hospital

Izmir, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 35170766 BACKGROUND

• 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.

  PMID: 35115286 BACKGROUND

• 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.

  PMID: 23997866 BACKGROUND

• 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.

  PMID: 39998019 BACKGROUND

• 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.

  PMID: 299611 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Patient Compliance; Treatment Adherence and Compliance; Health Behavior; Medication Adherence; Patient Participation

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Patient Acceptance of Health Care; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 14, 2026
• First Posted: June 17, 2026
• Study Start: February 1, 2024
• Primary Completion: August 12, 2024
• Study Completion: January 4, 2025
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)