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

NCT06015789 | Completed

• 1 other identifier: 5886 - IBD-Self
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• Evaluate the factors that affect the self-care of the patient with IBD, of the caregiver and of their dyadic interaction;

  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

  Day 0, 6 months, 12 months

Interventions

Questionnaire OTHER

Administration of questionnaires for the evaluation of self-care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The research is multicenter and will be conducted in the IBD units and in the medical departments of the centers that will decide to join, during visits or hospitalization. Male or female patient, adult.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Daniele Napolitano

Rome, 00168, Italy

Location

Related Publications (2)

• Napolitano D, Biagioli V, Bartoli D, Cilluffo S, Martella P, Monaci A, Vellone E, Cocchieri A. Validity and Reliability of the Self-Care of Chronic Illness Inventory in Patients Living With Inflammatory Bowel Disease. J Clin Nurs. 2025 Nov;34(11):4642-4653. doi: 10.1111/jocn.17712. Epub 2025 Mar 3.

  PMID: 40033448 DERIVED

• Napolitano D, Vellone E, Iovino P, Scaldaferri F, Cocchieri A. Self-care in patients affected by inflammatory bowel disease and caregiver contribution to self-care (IBD-SELF): a protocol for a longitudinal observational study. BMJ Open Gastroenterol. 2024 Aug 29;11(1):e001510. doi: 10.1136/bmjgast-2024-001510.

  PMID: 39209770 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Daniele Napolitano

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 29, 2023
• Study Start: September 4, 2023
• Primary Completion: October 1, 2024
• Study Completion: April 30, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-07

Locations

IT (1)