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Completed

NCT Number: NCT07177287

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

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.

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Key information

Conditions

Celiac Disease Adults With Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Etlik City Hospital

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IMB navigator app

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Adherence to Gluten-Free Diet

    Time frame: 6 months

    Measurement Tool: Self-reported adherence and dietary records. Outcome Metric: Percentage of adherence (%0-100).

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 16, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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