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Clinical Trials/NCT07555951
NCT07555951
Completed
Not Applicable

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

Izmir Katip Celebi University1 site in 1 country40 target enrollmentStarted: October 5, 2020Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Izmir Katip Celebi University
Enrollment
40
Locations
1
Primary Endpoint
Functional Medicine Self-Care Questionnaire Total Score

Overview

Brief Summary

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Masking Description

This is an open-label study. Participants and care providers are aware of group assignments due to the nature of the intervention.

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Aged between 18 and 65 years
  • 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

Arms & Interventions

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.

Intervention: Nurse Coaching (Behavioral)

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.

Intervention: Standard Education (Behavioral)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Inflammatory Bowel Disease Quality of Life Questionnaire Total Score(Baseline and 12 weeks)

Investigators

Sponsor
Izmir Katip Celebi University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Funda SOFULU

Associate Professor Dr.

Izmir Katip Celebi University

Study Sites (1)

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