Health-Related Quality of Life Among Patients With Inflammatory Bowel Disease

NCT07436910 | Enrolling By Invitation

• 1 other identifier: REC-2025-0006
• Study Type: observational
• Target: 385
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to assess HRQOL and its associated factors among people with IBD. The target sample will be 385 adult patients diagnosed with IBD (both Crohn's Disease and Ulcerative Colitis). The data will be collected using a self-administered survey.

Conditions

Irritable Bowel Disease; Ulcerative Colitis (UC); Crohn Disease (CD)

Keywords

HRQOL; IBD; QLQ-SWB; UC; CD

Outcome Measures

Primary Outcomes (3)

• Spirituality well-being

  The SWB scale has 32 items. All scales range from 0 to 100, with high scores representing positive spirituality. The SWB scale demonstrated strong reliability and validity.

  Single time point, one-time data collection

• Demographic and clinical characteristics

  Basic sociodemographic data, including the setting of data collection, age, sex, religion, education, and employment status. Clinical data, including the type of IBD, age of IBD diagnosis, and comorbidity.

  Single time point, one-time data collection

• HRQOL

  The Inflammatory Bowel Diseases Disability Index (IBD-DI) Disk is a brief version of the IBD-DI that allows assessing patients' self-perceived disability. It includes 10 domains: abdominal pain, energy, interpersonal interactions, bowel regulation, body image, sexual function, emotions, sleep, education/work, and joint pain. It has satisfactory validity and reliability.

  Single time point, one-time data collection

Secondary Outcomes (2)

• Perceived Social Support

  Single time point, one-time data collection

• Percived Self-Efficacy

  Single time point, one-time data collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population will be adult patients diagnosed with IBD in Egypt.

You may qualify if:

• years or older.
• Have a confirmed diagnosis of IBD.
• Can understand and complete the study questionnaires.
• Provide written informed consent to participate in the study.

You may not qualify if:

• Have a diagnosis of indeterminate colitis.
• Have any other chronic inflammatory conditions.
• Have severe cognitive impairment that hinders their ability to complete the questionnaires.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Colitis; Gastroenteritis; Inflammatory Bowel Diseases

Study Officials

• Naglaa Youssef

  Faculty of Nursing, Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 27, 2026
• Study Start: September 1, 2025
• Primary Completion: June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)