CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 250 enrolled
Drug / intervention
Questionnaireother
Likely dose
Not stated in record
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Search/NCT06015789
NCT06015789N/ACompleted

Self-care in Patients Affected by Inflammatory Bowel Disease and Caregivers' Contribution to Self-care

Fondazione Policlinico Universitario Agostino Gemelli IRCCS·observational·Posted Aug 29, 2023·Updated Jul 2, 2025

In Brief

An observational study evaluating Questionnaire for Inflammatory Bowel Diseases. Completed, enrolled 250 participants across 1 site.

Detailed Summary

The Inflammatory Bowel Disease (IBD) is a chronic inflammatory disease of the gastrointestinal tract including Crohn's disease and Ulcerative Colitis. The course of IBD is frequently progressive and can be hardly predictable, with sudden exacerbations of intestinal symptoms. Epidemiological studies have shown that IBD has an increasing prevalence to reach 10 million people in 2030. These diseases require frequent interactions between patients and the healthcare system, or symptom management with continuous therapies, gastroenterological visits, surgery, contacts for resolution of urgent symptoms from telephone and email, access to the emergency, hospitalizations, nutritional counseling, psychological interventions and follow-up controls. An IBD can completely disrupt a family's ability to function normally and often imposes a strain on family members' relationships. In the model of self-care in chronic diseases, according to Riegel's "Middle Range Theory", there are external factors, predictive factors that can influence and limit the patient's attitude and therefore his self-esteem, the ability to implement decision-making behaviors to improve and increase his self-care. There are also factors that influence a person's self-care decisions: the particular caregivers. In this process, the role of the caregiver and the dyad he establishes with the patient can influence the whole process of self-confidence and self-care. The objectives of the study are to investigate and describe self-care in patients with IBD and how their caregivers in dyadic interaction can contribute.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedAug 29, 2023
Enrollment StartSep 4, 2023
Primary CompletionOct 1, 2024
Study CompletionApr 30, 2025
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 2.8 years ago

Interventions

Questionnaireother

Administration of questionnaires for the evaluation of self-care