Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 design Multicentre prospective observational study
Population The study is multicentre and will be conducted at the Fondazione Policlinico Gemelli IRCCS in Rome as the reference centre together with the centres that decide to participate. Patients will be enrolled at the IBD centres, in the medical wards, during visits or during hospitalization. Follow-up will be after the first administration at T1 (6 months) and T2 (12 months). Subsequent questionnaires (T1 and T2) will be administered by telephone or telematically. The study will start as soon as it is approved by the Ethics Committee. The total duration of the study will not exceed 12 months from the last enrolment.
Duration of the study The study will last 12 months from the date of approval by the Ethics Committee. The study is hypothetically expected to be completed by the end of December 2024.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Other | Administration of questionnaires for the evaluation of self-care |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniele Napolitano | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daniele Napolitano | Rome | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42022938 | Derived | Cilluffo S, Bartoli D, Napolitano D, Biagioli V, Cocchieri A, Monaci A, Cesare M, Martella P, Petrosino F, Vellone E. Validity and Reliability of the Caregiver Contribution to Self-Care of Chronic Illness Inventory in Patients With Inflammatory Bowel Disease. JGH Open. 2026 Mar 19;10(3):e70340. doi: 10.1002/jgh3.70340. eCollection 2026 Mar. | |
| 40033448 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
| 39209770 | 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. |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |