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

Completed

• Conditions: Chronic Intestinal Failure
• Interventions: Other: Patient with chronic intestinal failure

• Registration Number: NCT05857254
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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

Detailed Description

Chronic intestinal failure (CIF) is a chronic disease and its main treatment is home parenteral nutrition. This disease is defined by a small bowel dysfunction preventing absorption of nutrients and water inputs. A " normal " oral diet is then insufficient, and must be supplied by an " artificial " parenteral nutrition. This treatment is administered at home, by a central veinous catheter, with varying volumes and frequencies.

The quality of life of patients treated by home parenteral nutrition is significatively altered .

The constraints linked to this treatment may make it difficult to follow. The patients can be lead to ask their doctor for a relief or a modification of this treatment during office visits, to improve their quality of life.

Poor treatment adherence concerns 25% of patients with chronic disease . It has never been assessed in France in CIF.

The goal of this study is to evaluate the treatment adherence for home parenteral nutrition in two of its components: negotiation during office visits, and compliance at home.

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.

Study Timeline

• Study First Submitted: 2023-04-20
• Study First Submitted QC: 2023-05-03
• Study First Posted: 2023-05-12
• Study Start: 2023-06-29
• Primary Completion: 2024-01-25
• Study Completion: 2024-01-25
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-26
• Last Update Posted: 2024-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic intestinal failure patient	Patient with chronic intestinal failure	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.

Primary Outcome Measures

Name	Time	Method
Difference in the volume of parenteral nutrition	Inclusion visit, 8 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Patient's compliance	Inclusion visit	Evaluation of the " perception of patients'compliance " by the coordinating nurse of the nutrition center by an analog visual scale. Analog visual scale is scored from 0 (good compliance) to 10 (poor compliance)
Anxiety and depression symptom	Inclusion visit	Identification of signs of anxiety and depression symptoms by the HADS form. The anxiety and depression scale consists of 14 questions that assess how subjects feel at the time and generally.
Patient's trust	Inclusion visit	Evaluation of patient's trust in their specialist physician by the WFPTS form. This scale assesses the patient trust's in their specialist ; it consists in 10 questions.

Trial Locations

Locations (6)

CHU de Grenoble; 🇫🇷 Grenoble, France

Hôpital de l'Archet; 🇫🇷 Nice, France

CHU Limoges; 🇫🇷 Limoges, France

CHU de Nantes; 🇫🇷 Nantes, France

CHU Bordeaux; 🇫🇷 Pessac, France

Institut régional du cancer Montpellier; 🇫🇷 Montpellier, France