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

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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07436910

Enrollment

385

Registered

2026-02-27

Start date

2025-09-01

Completion date

2026-12-30

Last updated

2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

HRQOL, IBD, QLQ-SWB, UC, CD

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.

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Demographic and clinical characteristics	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.
Spirituality well-being	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.
HRQOL	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

Measure	Time frame	Description
Perceived Social Support	Single time point, one-time data collection	The Oslo Social Support Scale (OSSS-3) is a three-item measure of social support.
Percived Self-Efficacy	Single time point, one-time data collection	A reliable and validated General Self-Efficacy Short Scale-3 (GSE-3) will be used.

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORNaglaa Youssef

Faculty of Nursing, Cairo University

Outcome results