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Enrolling by invitation NCT07436910

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Irritable Bowel Disease, Ulcerative Colitis (UC), Crohn Disease (CD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Health-Related Quality of Life and Associated Factors Among Patients With Inflammatory Bowel Disease: Cross-Sectional Multicentre Study

Overview

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.

Detailed description

The target population will be adult patients diagnosed with IBD. Participants will receive full information about the study's purpose, the voluntary nature of their participation, and the complete confidentiality of their data, including the right to withdraw at any point without explanation. Informed written consent will be obtained from each participant before they complete the questionnaires. Collected data will be stored securely on a password-protected computer and anonymized through coding.

Descriptive and inferential statistics will be used to analyze the data.

Primary outcome measures

  • Spirituality well-being [Time frame: Single time point, one-time data collection]
  • Demographic and clinical characteristics [Time frame: Single time point, one-time data collection]
  • HRQOL [Time frame: Single time point, one-time data collection]
Secondary outcome measures (2)
  • Perceived Social Support [Time frame: Single time point, one-time data collection]
  • Percived Self-Efficacy [Time frame: Single time point, one-time data collection]

Eligibility criteria

Inclusion criteria

  • 18 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Egypt · 1 center
  • Cairo University — Cairo

Identifiers

NCT: NCT07436910 · REC-2025-0006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗