Inflammatory Bowel DiseasesNCT07555951
Nurse Coaching on Symptom Management, Self-Care Activities, and Quality of Life in Individuals With Inflammatory Bowel Disease
A study testing Nurse Coaching and Standard Education in people with Inflammatory Bowel Diseases, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
The findings of this study are expected to provide evidence on the role of nurse coaching in supporting individuals with inflammatory bowel disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Nurse Coaching and Standard Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2020to 5 Jan 2021
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 65 years
- Literate
- Diagnosed with inflammatory bowel disease for at least 6 months
- In remission
- Conscious and cooperative
- Able to speak Turkish
Show all 9Show fewer
- No psychiatric disorders
- Willing to participate in the study
- Able to communicate with the researcher via telephone or email
Who cannot join
- Presence of additional chronic diseases (e.g., oncological diseases, diabetes, COPD)
- Acute disease exacerbation requiring hospitalization
- Diagnosis of celiac disease
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Nurse Coaching in Functional Health on Symptom Management, Self-Care Activities and Quality of Life in Individuals With Inflammatory Bowel Disease: Randomized Control Trial
The findings of this study are expected to provide evidence on the role of nurse coaching in supporting individuals with inflammatory bowel disease.
Read the detailed description
This randomized controlled trial aims to evaluate the effect of functional health-based nurse coaching on symptom management, self-care activities, and quality of life in individuals with inflammatory bowel disease.
A total of 40 individuals diagnosed with inflammatory bowel disease will be included in the study. Participants will be randomly assigned to either the intervention group (nurse coaching) or the control group (standard education), with 20 participants in each group. The intervention will be conducted over a 12-week period and will include 12 sessions.
The intervention group will receive individualized nurse coaching based on functional health principles, focusing on symptom management strategies, self-care activities, and lifestyle modification. The control group will receive standard education.
Data will be collected using the Inflammatory Bowel Diseases Patient Information Form, Functional Medicine Symptom Assessment Questionnaire, Functional Medicine Inflammatory Bowel Diseases Short Questionnaire, Inflammatory Bowel Diseases Activity Index, Functional Medicine Self-Care Questionnaire, and the Quality of Life Questionnaire for individuals with inflammatory bowel disease.
Outcome measures will be assessed at baseline and after the intervention period. This study is designed to determine the effectiveness of nurse coaching on improving health outcomes in individuals with inflammatory bowel disease.
This study aims to evaluate the effect of nurse coaching on symptom management, self-care activities, and quality of life in individuals with inflammatory bowel disease.
Participants will be randomly assigned to either a nurse coaching group or a control group receiving standard education. The nurse coaching intervention will focus on individualized support, symptom management, and lifestyle guidance over a 12-week period.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Nurse Coaching, Standard Education
- Keywords
- Functional Medicine, Nurse Coaching, Inflammatory Bowel Diseases
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse CoachingBehavioural
Nurse coaching based on functional health principles including individualized education, symptom management strategies, and support for self-care activities over a 12-week period.
Standard EducationBehavioural
Standard education routinely provided to individuals with inflammatory bowel disease without additional nurse coaching.
| Study group | Role | What they receive |
|---|---|---|
| Nurse Coaching | Experimental | Participants in the intervention group will receive nurse coaching based on functional health principles, including individualized education, symptom management strategies, and support for self-care activities over a 12-week period. Receives: Behavioral: Nurse Coaching |
| Standard Education | Active comparator | Participants in the control group will receive standard education routinely provided to individuals with inflammatory bowel disease without additional nurse coaching. Receives: Behavioral: Standard Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Medicine Self-Care Questionnaire Total Score
Self-care activities will be assessed using the Functional Medicine Self-Care Questionnaire. The total score will be calculated, with higher scores indicating better self-care activities.
Measured: Baseline and 12 weeks
Functional Medicine Symptom Assessment Questionnaire Total Score
Symptom management will be assessed using the Functional Medicine Symptom Assessment Questionnaire. Total scores will be calculated, with higher scores indicating greater symptom burden.
Measured: Baseline and 12 weeks
Secondary outcomes (1)
Inflammatory Bowel Disease Quality of Life Questionnaire Total Score
Quality of life will be assessed using the Inflammatory Bowel Disease Quality of Life Questionnaire. Total scores will be calculated, with higher scores indicating better quality of life.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start5 Oct 2020
- Primary completion5 Nov 2020
- Study completion5 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either the nurse coaching intervention group or the control group receiving standard education. The two groups will be followed in parallel over a 12-week period.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Funda SOFULU, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555951
- Sponsor's protocol ID
- KCU-IBD-RCT-2026
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared to ensure the confidentiality of participants and in accordance with institutional and ethical guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nurse Coaching in Functional Health on Symptom Management, Self-Care Activities and Quality of Life in Individuals With Inflammatory Bowel Disease: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07555951
- Acronym / sponsor ID
- KCU-IBD-RCT-2026
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Functional Medicine, Nurse Coaching, Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 5 Nov 2020 (actual)
- Study completion
- 5 Jan 2021 (actual)
- First posted
- 29 Apr 2026 (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.
The findings of this study are expected to provide evidence on the role of nurse coaching in supporting individuals with inflammatory bowel disease.
Detailed description
This randomized controlled trial aims to evaluate the effect of functional health-based nurse coaching on symptom management, self-care activities, and quality of life in individuals with inflammatory bowel disease.
A total of 40 individuals diagnosed with inflammatory bowel disease will be included in the study. Participants will be randomly assigned to either the intervention group (nurse coaching) or the control group (standard education), with 20 participants in each group. The intervention will be conducted over a 12-week period and will include 12 sessions.
The intervention group will receive individualized nurse coaching based on functional health principles, focusing on symptom management strategies, self-care activities, and lifestyle modification. The control group will receive standard education.
Data will be collected using the Inflammatory Bowel Diseases Patient Information Form, Functional Medicine Symptom Assessment Questionnaire, Functional Medicine Inflammatory Bowel Diseases Short Questionnaire, Inflammatory Bowel Diseases Activity Index, Functional Medicine Self-Care Questionnaire, and the Quality of Life Questionnaire for individuals with inflammatory bowel disease.
Outcome measures will be assessed at baseline and after the intervention period. This study is designed to determine the effectiveness of nurse coaching on improving health outcomes in individuals with inflammatory bowel disease.
This study aims to evaluate the effect of nurse coaching on symptom management, self-care activities, and quality of life in individuals with inflammatory bowel disease.
Participants will be randomly assigned to either a nurse coaching group or a control group receiving standard education. The nurse coaching intervention will focus on individualized support, symptom management, and lifestyle guidance over a 12-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the nurse coaching intervention group or the control group receiving standard education. The two groups will be followed in parallel over a 12-week period.
| Arm | Type | Receives |
|---|---|---|
| Nurse Coaching | Experimental | Behavioral: Nurse CoachingParticipants in the intervention group will receive nurse coaching based on functional health principles, including individualized education, symptom management strategies, and support for self-care activities over a 12-week period. |
| Standard Education | Active comparator | Behavioral: Standard EducationParticipants in the control group will receive standard education routinely provided to individuals with inflammatory bowel disease without additional nurse coaching. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged between 18 and 65 years
- Literate
- Diagnosed with inflammatory bowel disease for at least 6 months
- In remission
- Conscious and cooperative
Key exclusion criteria (4 listed)
- Presence of additional chronic diseases (e.g., oncological diseases, diabetes, COPD)
- Acute disease exacerbation requiring hospitalization
- Diagnosis of celiac disease
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Nurse CoachingNurse coaching based on functional health principles including individualized education, symptom management strategies, and support for self-care activities over a 12-week period. | Behavioural | Nurse Coaching |
| Standard EducationStandard education routinely provided to individuals with inflammatory bowel disease without additional nurse coaching. | Behavioural | Standard Education |
Primary outcome
Functional Medicine Self-Care Questionnaire Total Score
Time frame: Baseline and 12 weeks
Self-care activities will be assessed using the Functional Medicine Self-Care Questionnaire. The total score will be calculated, with higher scores indicating better self-care activities.
Functional Medicine Symptom Assessment Questionnaire Total Score
Time frame: Baseline and 12 weeks
Symptom management will be assessed using the Functional Medicine Symptom Assessment Questionnaire. Total scores will be calculated, with higher scores indicating greater symptom burden.
1 secondary outcome
Inflammatory Bowel Disease Quality of Life Questionnaire Total Score
Time frame: Baseline and 12 weeks
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 29 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared to ensure the confidentiality of participants and in accordance with institutional and ethical guidelines.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse Coaching and Standard Education in people with Inflammatory Bowel Diseases, run by Izmir Katip Celebi 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 9 inclusion and 4 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 29 Apr 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?
Functional Medicine Self-Care Questionnaire Total Score (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. 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 29 Apr 2026.