Perception of Needs of Patients With Chronic Intestinal Failure and Their Practitioners: a Qualitative Study

NCT04390633 | Unknown

• 1 other identifier: EI/2019/616
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The SBS NEEDS Study is a qualitative transversal study aiming to describe and understand the needs and knowledge of patients with Chronic Intestinal Failure as well as the representations of their practitioners Chronic Intestinal Failure (CIF) is the long-lasting reduction of gut function, below the minimum necessary for the absorption of macronutrients and/or water and electrolytes, such that intravenous supplementation is required to maintain health and/or growth. CIF is the rarest organ failure. Home parenteral nutrition (HPN) is the primary treatment for CIF. Semi-structured interviews will be conducted with patients in two nutrition unit and specialized in the small bowel diseases in two French region. 20 situations will be included. After analysing the data of the individual interviews, focus groups will be conducted with health professionals from an accredited home parenteral nutrition department.

Conditions

Chronic Intestinal Failure; Small Intestine Disease

Outcome Measures

Primary Outcomes (1)

• 20 semi-structured interviews

  Qualitative data analysis - Theorical saturation

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women aged 18 and over, fulfilling the conditions of major Chronic Intestinal Failure (CIF) : "reduction of the intestinal functional mass below the minimum mass sufficient to ensure the absorption of nutrients to maintain nutritional status"

You may qualify if:

• Men and women aged 18 and over
• With Chronic Intestinal Failure (CIF) : "reduction of the intestinal functional mass below the minimum mass sufficient to ensure the absorption of nutrients to maintain nutritional status"
• medical follow-up in one of the two nutrition departments of the study
• Informed consent stating that the subject understood the purpose and methodology of the study and agrees to participate in the study.

You may not qualify if:

• Persons with proven and significant cognitive impairment preventing the completion of semi-structured interviews
• Person who does not speak French easily
• Generally, any person unlikely to cooperate in the study
• Adults under guardianship

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• Société Francophone Nutrition Clinique et Métabolisme: collaborator

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 15, 2020
• Study Start: October 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: July 21, 2020

Record last verified: 2020-03