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

September 27, 2025 updated by: İlknur Bodur, Ankara Yildirim Beyazıt University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Navigator nurse-supported mobile application (IMB Model)
Participants receiving the navigator nurse-supported mobile application based on the IMB model.
Behavioral: 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.
No Intervention: Control: Standard care without mobile application
Participants receiving standard care without the mobile application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improving the quality of life of celiac patients
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to Gluten-Free Diet
Time Frame: 6 months
Measurement Tool: Self-reported adherence and dietary records. Outcome Metric: Percentage of adherence (%0-100).
6 months
Patient Motivation Level
Time Frame: 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.
6 months
Patient Engagement with the Mobile Application
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Yildirim Beyazıt University

Investigators

  • Study Director: Hilal TÜZER, Faculty of Health Sciences, Ankara Yıldırım Beyazıt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

September 10, 2025

First Submitted That Met QC Criteria

September 10, 2025

First Posted (Estimated)

September 16, 2025

Study Record Updates

Last Update Posted (Estimated)

September 30, 2025

Last Update Submitted That Met QC Criteria

September 27, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMB-CELIAC-QOL-2025-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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