Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)NCT07652840
Treatment Adherence Among Patients With Inflammatory Bowel Disease Receiving Anti-TNF Therapy
A study testing Health Belief Model-Based Structured Patient Education and Standard Patient Education in people with Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis) and Adherence, Patient, run by Izmir Katip Celebi University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis), Adherence, Patient, Structured Education
- What is being tested?
- Health Belief Model-Based Structured Patient Education and Standard Patient Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 4 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Izmir Ekonomi University Medical Point Hospital
Izmir
İzmir Atatürk Training and Research Hospital
Izmir
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis), Adherence, Patient, Structured Education
- Being tested
- Health Belief Model-Based Structured Patient Education, Standard Patient 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
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Patient Compliance, Treatment Adherence and Compliance, Health Behavior, Medication Adherence, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Belief Model-Based Structured Patient EducationBehavioural
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.
Standard Patient EducationBehavioural
Standard patient education routinely provided in outpatient clinical practice for patients receiving anti-TNF therapy, without a structured theoretical framework.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Patient Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-intervention), immediately post-intervention, and 1-month follow-up
Secondary outcomes (2)
Partners in Healthcare Scale
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.
Measured: Baseline (pre-intervention), immediately post-intervention, and 1-month follow-up
Patient Satisfaction With Education
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.
Measured: Immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Feb 2024
- Primary completion12 Aug 2024
- Study completion4 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nur Basak, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652840
- Sponsor's protocol ID
- 0588
- Status last verified
- Jun 2026
- First submitted
- 14 Feb 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 35170766Basak 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.
PubMed 35115286Sullivan 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.
PubMed 23997866King 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.
PubMed 39998019Cummings 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.
PubMed 299611
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07652840
- Acronym / sponsor ID
- 0588
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 12 Aug 2024 (actual)
- Study completion
- 4 Jan 2025 (actual)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Health Belief Model-Based Structured Patient Education | Experimental | Behavioral: Health Belief Model-Based Structured Patient EducationParticipants 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. |
| Standard Education | Active comparator | Behavioral: Standard Patient EducationParticipants received standard outpatient clinic education routinely provided as part of usual care for patients receiving anti-TNF therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Belief Model-Based Structured Patient EducationA 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. | Behavioural | Health Belief Model-Based Structured Patient Education |
| Standard Patient EducationStandard patient education routinely provided in outpatient clinical practice for patients receiving anti-TNF therapy, without a structured theoretical framework. | Behavioural | Standard Education |
Primary outcome
Anti-TNF Alpha Treatment Adherence Scale
Time frame: 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.
2 secondary outcomes
Partners in Healthcare Scale
Time frame: Baseline (pre-intervention), immediately post-intervention, and 1-month follow-up
Patient Satisfaction With Education
Time frame: Immediately post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Background: PubMed 35170766Ciftci 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.
- Background: PubMed 35115286Basak 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.
- Background: PubMed 23997866Sullivan 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.
- Background: PubMed 39998019King 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.
- Background: PubMed 299611Cummings 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.
- Individual participant dataSharing planned: No. 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.
Related trials for Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Belief Model-Based Structured Patient Education and Standard Patient Education in people with Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis) and Adherence, Patient, run by Izmir Katip Celebi University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-TNF Alpha Treatment Adherence Scale (time frame: Baseline (pre-intervention), immediately post-intervention, and 1-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07652840, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.