The Effect of a Navigator Nurse- Supported Mobile Application Developed Based on the IMB Model on the Quality of Life of Patients With Celiac Disease

Ankara Yildirim Beyazıt University

Status: Enrolling

Conditions: Celiac Disease; Adults With Celiac Disease

Treatments: Behavioral: IMB navigator app

Study type: Interventional

Funder types: Other

Identifiers

NCT07177287

IMB-CELIAC-QOL-2025-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Experimental: Navigator nurse-supported mobile application (IMB Model)

Experimental group

Description:

Participants receiving the navigator nurse-supported mobile application based on the IMB model.

Treatment:

Behavioral: IMB navigator app

Control: Standard care without mobile application

No Intervention group

Description:

Participants receiving standard care without the mobile application.