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.
Age ≥18 years
Newly diagnosed with celiac disease
Owning a smartphone and able to use the application
Able to speak and understand Turkish
Severe gluten hypersensitivity
Failure to meet inclusion criteria
Withdrawal of consent during the study
Parallel
IMB navigator app
BehavioralMobile 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.
Improving the quality of life of celiac patients
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.
Adherence to Gluten-Free Diet
Measurement Tool: Self-reported adherence and dietary records. Outcome Metric: Percentage of adherence (%0-100).
Patient Motivation Level
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
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.
Click on the lead sponsor to view all of their trials.
