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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Intestinal Failure
• Intervention / Treatment: Other: Patient 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 Type: Observational
• Enrollment (Actual): 126

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • CHU de Grenoble
  • Limoges, France
    • CHU Limoges
  • Montpellier, France
    • Institut regional du Cancer Montpellier
  • Nantes, France
    • CHU de Nantes
  • Nice, France, 06202
    • Hôpital de l'Archet
  • Pessac, France, 33600
    • CHU Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient with chronic intestinal failure

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Florian POULLENOT, MD, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2023
• Primary Completion (Actual): January 25, 2024
• Study Completion (Actual): January 25, 2024

Study Registration Dates

• First Submitted: April 20, 2023
• First Submitted That Met QC Criteria: May 3, 2023
• First Posted (Actual): May 12, 2023

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Treatment adherence; Chronic intestinal failure
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Failure
• Other Study ID Numbers: CHUBX 2023/09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No