Clinical trial NCT05857254: Treatment Adherence of Home Parenteral Nutrition in Patients With Chronic Intestinal Failure. (QANPIC)
Official title: What Treatment Adherence for Home Parenteral Nutrition in Patients With Chronic Intestinal Failure ?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Intestinal Failure
Keywords: Chronic intestinal failure
Treatment adherence
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with chronic intestinal failure

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Difference in the volume of parenteral nutrition
timeFrame: Inclusion visit, 8 weeks
Secondary outcomes:
measure: Patient's compliance
timeFrame: Inclusion visit
measure: Anxiety and depression symptom
timeFrame: Inclusion visit
measure: Patient's trust
timeFrame: Inclusion visit
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU de Grenoble
city: Limoges
country: France
facility: CHU Limoges
city: Montpellier
country: France
facility: Institut régional du cancer Montpellier
city: Nantes
country: France
facility: CHU de Nantes
city: Nice
country: France
facility: Hôpital de l'Archet
city: Pessac
country: France
facility: CHU Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Florian POULLENOT, MD
role: PRINCIPAL_INVESTIGATOR
References: