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

NCT ID: NCT07177287

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-06-01

Brief Summary

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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

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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.

Conditions

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Celiac Disease Adults With Celiac Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

IMB navigator app

Intervention Type BEHAVIORAL

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.

Control: Standard care without mobile application

Participants receiving standard care without the mobile application.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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IMB 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

* Withdrawal of consent during the study

Exclusion Criteria

* Severe gluten hypersensitivity
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara Yildirim Beyazıt University

OTHER

Sponsor Role lead

Responsible Party

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İlknur Bodur

Research Nurse / MSN (Master of Science in Nursing)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hilal TÜZER

Role: STUDY_DIRECTOR

Faculty of Health Sciences, Ankara Yıldırım Beyazıt University

Locations

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Ankara Etlik City Hospital

Ankara, Ankara, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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İlknur Bodur, PhD Candidate, Researcher

Role: CONTACT

+90505-585-56-65

Hilal TÜZER, Associate Professor

Role: CONTACT

+905355720437

Facility Contacts

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İlknur Bodur

Role: primary

+90505-585-56-65

Other Identifiers

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IMB-CELIAC-QOL-2025-1

Identifier Type: -

Identifier Source: org_study_id

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