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

16. juni 2026 oppdatert av: Nur Basak, Izmir Katip Celebi University

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

140

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Tyrkia (Türkiye)
      • Izmir, Tyrkia (Türkiye)
        • Izmir Ekonomi University Medical Point Hospital
      • Izmir, Tyrkia (Türkiye)
        • Izmir Ataturk Training and Research Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: Health 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.
Aktiv komparator: Standard Education
Participants received standard outpatient clinic education routinely provided as part of usual care for patients receiving anti-TNF therapy.
Atferdsmessig: Standard Patient Education
Standard patient education routinely provided in outpatient clinical practice for patients receiving anti-TNF therapy, without a structured theoretical framework.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Anti-TNF Alpha Treatment Adherence Scale
Tidsramme: 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.
Baseline (pre-intervention), immediately post-intervention, and 1-month follow-up

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Partners in Healthcare Scale
Tidsramme: 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.
Baseline (pre-intervention), immediately post-intervention, and 1-month follow-up
Patient Satisfaction With Education
Tidsramme: 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.
Immediately post-intervention

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Izmir Katip Celebi University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. februar 2024

Primær fullføring (Faktiske)

12. august 2024

Studiet fullført (Faktiske)

4. januar 2025

Datoer for studieregistrering

Først innsendt

14. februar 2026

Først innsendt som oppfylte QC-kriteriene

16. juni 2026

Først lagt ut (Faktiske)

17. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 0588

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data (IPD) will not be shared because the data include sensitive health information collected from a relatively small patient population. Although all analyses were conducted using anonymized datasets, sharing IPD could pose a risk of indirect participant identification. Additionally, the informed consent obtained from participants did not include permission for public data sharing beyond aggregated and de-identified results.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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