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

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06015789
• Other study ID #: 5886
• Status: Enrolling by invitation
• Start date: September 4, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: August 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: October 1, 2024
• Est. primary completion date: February 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Other:
• Questionnaire
Administration of questionnaires for the evaluation of self-care

Locations

Country	Name	City	State
Italy	Daniele Napolitano	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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