Spiritual Needs of European Patients With Inflammatory Bowel Disease and Their Caregivers (Spirit@IBD)

University of Padova

Status

Begins enrollment in 2 months

Conditions

Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)

Study type

Observational

Funder types

Other

Identifiers

NCT07020481

SpNs-IBD-01

Details and patient eligibility

About

A European-wide cross-sectional non-interventional study, initiated by a pilot study in Italy, will be conducted. The first phase of the pilot study is a 6-step translation, adaptation, and validation of the extended version of the Spiritual Needs Questionnaire (SpNQ-EV) and the Interpretation of Illness Questionnaire (IIQ) adopting the methodology [3] described in figure 1. To ensure they are both valid and user-friendly, the Thinking Out Loud (TOL) technique (think-aloud method) will pre-test their self-administration and provide fine tuning of the secondary objectives of the study. TOL involves participants verbalizing their thoughts while completing the questionnaires, allowing to capture real-time insights into their understanding, interpretation, and potential challenges with questionnaires' items. The second phase will consist of an anonymous e-survey consisting of the six questionnaires described in table 1 including the translated and validated SPNQ-EV and IIQ developed in phase 1. The European study will employ a multilingual anonymous e-survey developed to ensure accessibility in participants' native languages, eventually preceded by country-based pilot studies. Eligible participants include adolescents and adults with IBD, as well as their caregivers, recruited via nurses and patient associations.

Enrollment

1,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: