Treatment Adherence of Home Parenteral Nutrition in Patients With Chronic Intestinal Failure. (QANPIC)

NCT05857254 | Completed

• 1 other identifier: CHUBX 2023/09
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 6

Brief Summary

This observational, cross-sectionnal, multicentric study evaluates treatment adherence of home parenteral nutrition in patients with chronic intestinal failure.

Conditions

Chronic Intestinal Failure

Keywords

Chronic intestinal failure; Treatment adherence

Outcome Measures

Primary Outcomes (1)

• Difference in the volume of parenteral nutrition

  A 10% (or more) difference between " ideal " and " final " prescriptions (one week's assessment of volume difference in mL) And/or During telephone survey, highlighting a 10% (or more) difference in nutrition received, compared to what is indicated on the prescription (assessment done on the difference in volume in mL over a week).

  Inclusion visit, 8 weeks

Secondary Outcomes (3)

• Patient's compliance

  Inclusion visit

• Anxiety and depression symptom

  Inclusion visit

• Patient's trust

  Inclusion visit

Study Arms (1)

Chronic intestinal failure patient

Patient with chronic intestinal failure and with home parenteral nutrition treatment stable for at least 3 months and with home parenteral nutrition treatment for at least 6 months.

Other: Patient with chronic intestinal failure

Interventions

Patient with chronic intestinal failure OTHER

The negociation component will be assessed during an office visit with the help of forms, by the difference between " ideal " parenteral nutrition prescription proposed by prescriber and the " final " prescription, that the patient ultimately receives at the end of the office visit. The compliance component will be assessed by a telephone interview, 8 weeks after the office visit.

Chronic intestinal failure patient

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

Patient with chronic intestinal failure

You may qualify if:

• Age 18 or older.
• Diagnosis of CIF (insufficiency of intestinal absorptive, motor or vascular functions that require parenteral nutrition).
• Home parenteral nutrition treatment for at least 6 months.
• With home parenteral nutrition treatment stable for at least 3 months.
• Agreeing to participate in research protocol.

You may not qualify if:

• Any condition that does not let a telephone interview (example : deafness, severe neurocognitive impairment).

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (6)

CHU de Grenoble

Grenoble, 38043, France

Location

CHU Limoges

Limoges, France

Location

Institut régional du cancer Montpellier

Montpellier, France

Location

CHU de Nantes

Nantes, France

Location

Hôpital de l'Archet

Nice, 06202, France

Location

CHU Bordeaux

Pessac, 33600, France

Location

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Florian POULLENOT, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 12, 2023
• Study Start: June 29, 2023
• Primary Completion: January 25, 2024
• Study Completion: January 25, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-04

Locations

FR (6)