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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Not yet recruiting ID

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire

Study Design

Study Type:
Anticipated Enrollment :
250 participants
Observational Model:
Time Perspective:
Official Title:
Self-care in Patients Affected by Inflammatory Bowel Disease and Caregivers' Contribution to Self-care
Anticipated Study Start Date :
Sep 4, 2023
Anticipated Primary Completion Date :
Feb 5, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Evaluate the factors that affect the self-care of the patient with IBD, of the caregiver and of their dyadic interaction; [Day 0, 6 months, 12 months]

    Evaluate through the administration of validated questionnaires the level of self-care of outpatient or inpatient IBD patients and their caregivers and correlate it with quality of life, anxiety, stress and other predictive factors

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  • age 18 or older;

  • voluntary participation in the study;

  • patient with the diagnosis of IBD outpatients and non-hospitalized;

  • caregiver of patients with IBD diagnosis outpatients and hospitalised;

  • Reading and signing informed consent

Exclusion Criteria:
  • patients with a diagnosis of IBD for less than 12 months;

  • caregivers of patients with an IBD diagnosis for fewer than 12 months;

  • patients operated for less than 6 months; care providers of patients operating less than six months;

  • reduced mastery of the Italian language;

  • subjects suffering from serious psychiatric disorders;

  • serious clinical conditions that would not allow the completion of the questionnaire;

  • refusal to sign the informed consent to participate in the study

Contacts and Locations


No locations specified.

Sponsors and Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Identifier:
Other Study ID Numbers:
  • 5886
First Posted:
Aug 29, 2023
Last Update Posted:
Aug 29, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 29, 2023