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

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

Detailed Description
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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.

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

Conditions
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Chronic Intestinal Failure

Intervention / Treatment
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* Other: Patient with chronic intestinal failure


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic intestinal failure patient<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic intestinal failure, Treatment adherence