NCT07555951

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2021

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

April 14, 2026

Last Update Submit

April 21, 2026

Conditions

Keywords

Functional MedicineNurse CoachingInflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline and 12 weeks

Secondary Outcomes (1)

  • Inflammatory Bowel Disease Quality of Life Questionnaire Total Score

    Baseline and 12 weeks

Study Arms (2)

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.

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.

Behavioral: Standard Education

Interventions

Nurse CoachingBEHAVIORAL

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

Standard education routinely provided to individuals with inflammatory bowel disease without additional nurse coaching.

Standard Education

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Presence of additional chronic diseases (e.g., oncological diseases, diabetes, COPD)
  • Acute disease exacerbation requiring hospitalization
  • Diagnosis of celiac disease
  • Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Katip Celebi University

Çiğli, İzmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study. Participants and care providers are aware of group assignments due to the nature of the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Dr.

Study Record Dates

First Submitted

April 14, 2026

First Posted

April 29, 2026

Study Start

October 5, 2020

Primary Completion

November 5, 2020

Study Completion

January 5, 2021

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared to ensure the confidentiality of participants and in accordance with institutional and ethical guidelines.

Locations