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Enrolling by Invitation

NCT Number: NCT07436910

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

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.

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Key information

Conditions

Irritable Bowel Disease Colitis Colitis, Ulcerative Colonic Diseases Colonic Diseases, Functional Crohn Disease Crohn Disease (CD) Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Irritable Bowel Syndrome Ulcerative Colitis (UC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Spirituality well-being

    Time frame: Single time point, one-time data collection

    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.

  2. Demographic and clinical characteristics

    Time frame: Single time point, one-time data collection

    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.

  3. HRQOL

    Time frame: Single time point, one-time data collection

    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.

Secondary outcomes

  1. Perceived Social Support

    Time frame: Single time point, one-time data collection

    The Oslo Social Support Scale (OSSS-3) is a three-item measure of social support.

  2. Percived Self-Efficacy

    Time frame: Single time point, one-time data collection

    A reliable and validated General Self-Efficacy Short Scale-3 (GSE-3) will be used.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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