An observational study in Chronic Intestinal Failure, sponsored by University Hospital, Bordeaux. Completed at 6 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-29.
Sponsored by University Hospital, Bordeaux · Observational
This observational, cross-sectionnal, multicentric study evaluates treatment adherence of home parenteral nutrition in patients with chronic intestinal failure.
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.
128 studies on the registry are indexed under Treatment Adherence and Compliance; 64 are open to participants now.
This study's enrollment of 126 is below the median of 281 across 21 observational studies indexed under Treatment Adherence and Compliance.
Browse Treatment Adherence and Compliance studies →University Hospital, Bordeaux is the lead sponsor of 803 studies on the registry; 194 are open to participants now.
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Patient with chronic intestinal failure
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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).
Time frame: Inclusion visit, 8 weeks
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)
Time frame: 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.
Time frame: 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.
Time frame: Inclusion visit
Ran from Jun 2023 to primary completion in Jan 2024, 6 months.
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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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