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Clinical Trials/NCT04390633
NCT04390633
Unknown
Not Applicable

Qualitative Assessment of the Needs and Knowledge of Patients With Chronic Intestinal Failure of Their Disease as Well as Those of Their Practitioners

Centre Hospitalier Universitaire de Besancon0 sites20 target enrollmentOctober 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Intestinal Failure
Sponsor
Centre Hospitalier Universitaire de Besancon
Enrollment
20
Primary Endpoint
20 semi-structured interviews
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
December 31, 2022
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

20 semi-structured interviews

Time Frame: 12 months

Qualitative data analysis - Theorical saturation

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