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

Chronic Intestinal Failure Clinical Trial

Official title:

What Treatment Adherence for Home Parenteral Nutrition in Patients With Chronic Intestinal Failure ?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05857254
• Other study ID #: CHUBX 2023/09
• Status: Completed
• Start date: June 29, 2023
• Est. completion date: January 25, 2024

Study information

• Verified date: April 2024
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: January 25, 2024
• Est. primary completion date: January 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Intestinal Failure
• Intestinal Failure

Intervention

Other:
• Patient with chronic intestinal failure
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.

Locations

Country	Name	City	State
France	CHU de Grenoble	Grenoble
France	CHU Limoges	Limoges
France	Institut régional du cancer Montpellier	Montpellier
France	CHU de Nantes	Nantes
France	Hôpital de l'Archet	Nice
France	CHU Bordeaux	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient's compliance	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)	Inclusion visit
Secondary	Anxiety and depression symptom	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.	Inclusion visit
Secondary	Patient's trust	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.	Inclusion visit