Clinical trial NCT06015789: Self-care in Patients Affected by Inflammatory Bowel Disease and Caregivers' Contribution to Self-care
Official title: Self-care in Patients Affected by Inflammatory Bowel Disease and Caregivers' Contribution to Self-care
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the factors that affect the self-care of the patient with IBD, of the caregiver and of their dyadic interaction;
timeFrame: Day 0, 6 months, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Daniele Napolitano
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Daniele Napolitano
role: PRINCIPAL_INVESTIGATOR
References: