Celiac DiseaseNCT07177287
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
A study testing IMB navigator app in people with Celiac Disease and Adults With Celiac Disease, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Celiac Disease, Adults With Celiac Disease
- What is being tested?
- IMB navigator app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Severe gluten hypersensitivity
- Failure to meet inclusion criteria
- Withdrawal of consent during the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Celiac Disease, Adults With Celiac Disease
- Being tested
- IMB navigator app
- Keywords
- quality of life, navigator nurse, mobile application, IMB model
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMB navigator appBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Navigator nurse-supported mobile application (IMB Model) | Experimental | Participants receiving the navigator nurse-supported mobile application based on the IMB model. Receives: Behavioral: IMB navigator app |
| Control: Standard care without mobile application | No intervention | Participants receiving standard care without the mobile application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
Adherence to Gluten-Free Diet
Measurement Tool: Self-reported adherence and dietary records. Outcome Metric: Percentage of adherence (%0-100).
Measured: 6 months
Patient Motivation Level
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.
Measured: 6 months
Patient Engagement with the Mobile Application
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Aug 2025
- Primary completion1 Feb 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlknur Bodur, Ankara Yildirim Beyazıt University
- Investigators
- Hilal TÜZER, Study director, Faculty of Health Sciences, Ankara Yıldırım Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177287
- Sponsor's protocol ID
- IMB-CELIAC-QOL-2025-1
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07177287
- Acronym / sponsor ID
- IMB-CELIAC-QOL-2025-1
- Conditions
- Celiac Disease, Adults With Celiac Disease
- Keywords
- quality of life, navigator nurse, mobile application, IMB model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Navigator nurse-supported mobile application (IMB Model) | Experimental | Behavioral: IMB navigator appParticipants receiving the navigator nurse-supported mobile application based on the IMB model. |
| Control: Standard care without mobile application | No intervention | –Participants receiving standard care without the mobile application. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- Severe gluten hypersensitivity
- Failure to meet inclusion criteria
- Withdrawal of consent during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMB navigator appMobile 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. | Behavioural | Experimental: Navigator nurse-supported mobile application (IMB Model) |
Primary outcome
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.
3 secondary outcomes
Adherence to Gluten-Free Diet
Time frame: 6 months
Patient Motivation Level
Time frame: 6 months
Patient Engagement with the Mobile Application
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilal TÜZER study director
Faculty of Health Sciences, Ankara Yıldırım Beyazıt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMB navigator app in people with Celiac Disease and Adults With Celiac Disease, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improving the quality of life of celiac patients (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.