Inflammatory Bowel DiseasesIBD-SelfNCT06015789
Self-care in Patients Affected by Inflammatory Bowel Disease and Caregivers' Contribution to Self-care
An observational study of Inflammatory Bowel Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Questionnaire
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 4 Sep 2023to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Questionnaire
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Administration of questionnaires for the evaluation of self-care
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start4 Sep 2023
- Primary completion1 Oct 2024
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniele Napolitano, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015789
- Sponsor's protocol ID
- 5886 - IBD-Self
- Acronym
- IBD-Self
- Status last verified
- Jul 2025
- First submitted
- 2 Aug 2023
- Last updated
- 2 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 42022938Napolitano 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.
PubMed 40033448Napolitano 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.
PubMed 39209770
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-care in Patients Affected by Inflammatory Bowel Disease and Caregivers' Contribution to Self-care
- ClinicalTrials.gov ID
- NCT06015789
- Acronym / sponsor ID
- IBD-Self / 5886 - IBD-Self
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAdministration of questionnaires for the evaluation of self-care | Other | – |
Primary outcome
Evaluate the factors that affect the self-care of the patient with IBD, of the caregiver and of their dyadic interaction;
Time frame: Day 0, 6 months, 12 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Derived from this study: PubMed 42022938Cilluffo 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.
- Derived from this study: PubMed 40033448Napolitano 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.
- Derived from this study: PubMed 39209770Napolitano 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniele Napolitano principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the factors that affect the self-care of the patient with IBD, of the caregiver and of their dyadic interaction; (time frame: Day 0, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06015789, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.