Adults With Celiac Disease, Celiac Disease
Conditions
Keywords
quality of life, navigator nurse, mobile application, IMB model
Brief summary
This randomized controlled trial aims to evaluate the effect of a navigator nurse-supported mobile application, developed based on the Information-Motivation-Behavioral Skills (IMB) model, on the quality of life of adult patients newly diagnosed with celiac disease. Participants will be randomized into intervention and control groups. The intervention group will use the mobile application with navigator nurse support for six months, while the control group will receive routine clinical education. Outcomes will be assessed through validated questionnaires and clinical data.
Detailed description
Celiac disease is an autoimmune disorder characterized by gluten intolerance, leading to intestinal mucosal damage and a variety of physical and psychological symptoms. Strict adherence to a gluten-free diet remains the only effective treatment but is challenging due to hidden gluten sources and limited knowledge. The IMB model provides a theoretical framework suggesting that health-related behaviors are influenced by information, motivation, and behavioral skills. A navigator nurse can support patients by providing education, motivation, and personalized guidance. In this study, a mobile application was developed to provide education and continuous support to celiac patients under the guidance of a navigator nurse. The study hypothesizes that this intervention will improve health-related quality of life compared to standard clinical education.
Interventions
BEHAVIORALIMB navigator app
Mobile application developed based on the IMB model, supported by a navigator nurse. Includes educational content, reminders and behavioral support. Patients will be followed for 6 months.
Sponsors
Ankara Yildirim Beyazıt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Newly diagnosed with celiac disease * Owning a smartphone and able to use the application * Able to speak and understand Turkish * Voluntary participation (informed consent)
Exclusion criteria
* Severe gluten hypersensitivity * Failure to meet inclusion criteria * Withdrawal of consent during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improving the quality of life of celiac patients | 6 months | Change in quality of life scores measured by a validated questionnaire for celiac disease patients (e.g., Celiac Disease Quality of Life Survey) from baseline to the end of the intervention. Health-Related Quality of Life Questionnaire in Celiac Disease: The questionnaire was developed by Hauser et al. and validated in Turkey by Aksan et al. It assesses how adult celiac patients have felt over the past two weeks by asking about disease-related symptoms, general well-being, and emotional state. The questionnaire consists of 28 items, evaluated across four subscales: emotional, social, gastrointestinal, and worries. Each item is rated on a 7-point Likert scale. Participants can score a minimum of 0 and a maximum of 49 points in each subscale. The total score ranges between 0 and 196, with lower scores reflecting lower quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Gluten-Free Diet | 6 months | Measurement Tool: Self-reported adherence and dietary records. Outcome Metric: Percentage of adherence (%0-100). |
| Patient Motivation Level | 6 months | Measurement Tool: Motivation Assessment Tool (developed by the investigator based on literature review; validated by Content Validity Index \[CVI\]). Outcome Metric: Item-based evaluation; mean score will be calculated for each item, and higher mean values will indicate greater motivation. |
| Patient Engagement with the Mobile Application | 6 months | Measurement Tool: In-app communication records (number of questions asked to the navigator nurse, number of forum posts/replies). Outcome Metric: Average number of patient-initiated questions and forum interactions per month. |
Countries
Turkey (Türkiye)
Contacts
STUDY_DIRECTORHilal TÜZER
Faculty of Health Sciences, Ankara Yıldırım Beyazıt University
Outcome results
None listed