Chronic Care Model on Symptom Status, Stress and Quality of Life in Individuals With Inflammatory Bowel Disease

NCT06757231 | Active Not Recruiting

• 1 other identifier: HKÜ-SAKBEN-2023/73
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effects of nurse counseling provided based on the Chronic Care Model on symptom status, stress, and quality of life in individuals diagnosed with Inflammatory Bowel Disease (IBD).

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Keywords

Crohn Disease; Inflamatory Bowl Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (3)

• Symptom status will be evaluated using the Inflammatory Bowel Disease Disease Activity Index .This scale measures disease activity and associated symptoms.

  the impact of nursing counseling, in the patient before in Symptom Status

  12 weeks

• Stress levels will be assessed using the Perceived Stress Scale (PSS-14). The PSS-14 evaluates perceived stress levels in daily life and how individuals cope with stress.

  the impact of nursing counseling, in the patient before and after on the stress levels

  12 weeks

• Quality of life will be assessed using the Inflammatory Bowel Disease Quality of Life scale. Changes in quality of life scores will be evaluated over time to determine improvements.

  the impact of nursing counseling, in the patient before and after in Quality of Life

  12 weeks

Study Arms (2)

İntervention Group

EXPERIMENTAL

Patients in the intervention group will receive nurse counseling based on the Chronic Care Model (CCM). The intervention includes: An initial face-to-face meeting where the patient is informed about the study, and informed consent is obtained. Administration of scales and forms such as the Patient Information Form, IBD Activity Indices, Symptom Assessment Form, Perceived Stress Scale (PSS-14), IBD Quality of Life Scale, and the Chronic Illness Care Evaluation Scale. Regular biweekly phone calls and weekly informational messages focusing on patient-specific needs, providing education and guidance on IBD management, and addressing any concerns. Educational materials, including a booklet, will be provided. The nurse will also assist with managing symptoms, stress, and improving quality of life. Follow-up evaluation at the end of 3 months with re-administration of the scales and forms.

Behavioral: Nurse Counseling Based on the Chronic Care Model (CCM)

Control Group

EXPERIMENTAL

Patients in the control group will receive standard care without the enhanced counseling provided to the intervention group. The interventions include: An initial meeting where the patient is informed about the study, and informed consent is obtained. Administration of scales and forms such as the Patient Information Form, IBD Activity Indices, Symptom Assessment Form, Perceived Stress Scale (PSS-14), IBD Quality of Life Scale, and the Chronic Illness Care Evaluation Scale. Reminder calls before scheduled appointments and assistance with rescheduling if needed. Follow-up evaluation at the end of 3 months with re-administration of the scales and forms.

Behavioral: Nurse Counseling Based on the Chronic Care Model (CCM)

Interventions

Nurse Counseling Based on the Chronic Care Model (CCM) BEHAVIORAL

This intervention involves personalized nurse counseling for patients diagnosed with Inflammatory Bowel Disease (IBD) based on the Chronic Care Model. The intervention includes: Biweekly phone consultations and weekly informational messages to provide education and support for symptom management, stress reduction, and quality-of-life improvement. An educational booklet to aid self-management. Follow-ups to assess progress, address concerns, and provide guidance on IBD management strategies.

Also known as: Chronic Care Counseling

Control Group; İntervention Group

Eligibility Criteria

• Age: 12 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- Individuals diagnosed with IBD who agree to participate in the study will be included after written informed consent form and informed consent form are obtained.
• Have a confirmed diagnosis of IBD at least 6 months ago,
• No obstacles to communication,
• Can use a smartphone,
• It will be determined from volunteers who agree to participate in the research on a voluntary basis.

You may not qualify if:

• \- IBHs for whom written consent cannot be obtained will be excluded from the study.
• Those who wish to leave the research without completing the research with their own consent,
• Patients who cannot have at least 3 interviews,
• Patients who do not show up for the appointment for the final test will not be included.

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Seval AKBEN

Gaziantep, 27410, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• seval akben

  Hasan Kalyoncu University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study involved concrete concepts such as counseling and education, making it impossible to blind participants and researchers. However, the statistical analyses of the data were conducted by a statistics expert, and blinding was achieved during the statistical analysis phase since the groups were identified only by numbers.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Two groups with a randomised controlled trial

Study Record Dates

• First Submitted: May 19, 2024
• First Posted: January 3, 2025
• Study Start: February 13, 2024
• Primary Completion: July 1, 2024
• Study Completion: January 7, 2025
• Last Updated: January 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)