Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06015789
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2023-08-02
Brief Title:
Self-care in Patients Affected by Inflammatory Bowel Disease and Caregivers Contribution to Self-care
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Self-care in Patients Affected by Inflammatory Bowel Disease and Caregivers Contribution to Self-care
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IBD-Self
Brief Summary:
The Inflammatory Bowel Disease IBD is a chronic inflammatory disease of the gastrointestinal tract including Crohns 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 familys ability to function normally and often imposes a strain on family members relationships In the model of self-care in chronic diseases according to Riegels Middle Range Theory there are external factors predictive factors that can influence and limit the patients 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 persons 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None