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

NCT07177287 | Completed DMC

• 1 other identifier: IMB-CELIAC-QOL-2025-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Celiac Disease; Adults With Celiac Disease

Keywords

quality of life; navigator nurse; mobile application; IMB model

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (3)

• Adherence to Gluten-Free Diet

  6 months

• Patient Motivation Level

  6 months

• Patient Engagement with the Mobile Application

  6 months

Study Arms (2)

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

EXPERIMENTAL

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

Behavioral: IMB navigator app

Control: Standard care without mobile application

NO INTERVENTION

Participants receiving standard care without the mobile application.

Interventions

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Severe gluten hypersensitivity
• Withdrawal of consent during the study

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Hilal TÜZER

  Faculty of Health Sciences, Ankara Yıldırım Beyazıt University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Nurse / MSN (Master of Science in Nursing)

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 16, 2025
• Study Start: August 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: June 1, 2026
• Last Updated: July 17, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)