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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 ?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05857254
Enrollment
126
Registered
2023-05-12
Start date
2023-06-29
Completion date
2024-01-25
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Intestinal Failure

Keywords

Chronic intestinal failure, Treatment adherence

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.

Interventions

OTHERPatient 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.

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Difference in the volume of parenteral nutritionInclusion visit, 8 weeksA 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

MeasureTime frameDescription
Patient's complianceInclusion visitEvaluation 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 symptomInclusion visitIdentification 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 trustInclusion visitEvaluation 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026