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Completed

NCT Number: NCT05857254

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Grenoble, Grenoble, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Patient with chronic intestinal failure

Other

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.

Primary outcomes

  1. Difference in the volume of parenteral nutrition

    Time frame: 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 outcomes

  1. Patient's compliance

    Time frame: 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)

  2. Anxiety and depression symptom

    Time frame: 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.

  3. Patient's trust

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 12, 2023
Registry last updated
Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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