- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07555951
Nurse Coaching on Symptom Management, Self-Care Activities, and Quality of Life in Individuals With Inflammatory Bowel Disease
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
İzmir
-
Çiğli, İzmir, Turkey (Türkiye)
- İzmir Katip Çelebi University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
- No psychiatric disorders
- Willing to participate in the study
- Able to communicate with the researcher via telephone or email
Exclusion Criteria:
- Presence of additional chronic diseases (e.g., oncological diseases, diabetes, COPD)
- Acute disease exacerbation requiring hospitalization
- Diagnosis of celiac disease
- Pregnant or breastfeeding women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nurse Coaching
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.
|
Nurse coaching based on functional health principles including individualized education, symptom management strategies, and support for self-care activities over a 12-week period.
|
|
Active Comparator: Standard Education
Participants in the control group will receive standard education routinely provided to individuals with inflammatory bowel disease without additional nurse coaching.
|
Standard education routinely provided to individuals with inflammatory bowel disease without additional nurse coaching.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and 12 weeks
|
|
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.
|
Baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inflammatory Bowel Disease Quality of Life Questionnaire Total Score
Time Frame: Baseline and 12 weeks
|
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.
|
Baseline and 12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KCU-IBD-RCT-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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