Management of Undernutrition on Discharge From Hospital by Dieticians and Physical Activity Teachers at Home

Official title

Prise en Charge de la dénutrition en Sortie d'Hospitalisation Par Des diététiciennes et Des Enseignants en activité Physique adapté à Domicile : étude de faisabilité (DENUTADOM)

Overview

The DENUTADOM study is a single-center feasibility study. It is an interventional research project involving human subjects (RIPH2), which will lead to a change in the care and treatment of adult patients diagnosed as suffering from moderate to severe undernutrition during hospitalization. The aim of this study was to assess patient compliance with a new undernutrition management program (diet and physical activity) at discharge from hospital. In this study, during hospitalization, patients may be included in the study if they meet the inclusion criteria. To this end, the physician will offer to participate in the study, and will provide the patient with an information document. If the patient agrees to take part, he or she will be included in the study after signing the consent form. Participation will last 3 months. On inclusion, after seeing the physician, an adapted physical activity teacher (EAPA) and a hospital dietician will assess the patient's physical capacities and dietary needs, in order to draw up an adapted physical and dietary program. The CRA will assess the patient's quality of life using a questionnaire. When the patient is discharged, he will be given a notebook in which to keep track of appointments with healthcare professionals (GP, private dietician, EAPA). Patients are also asked to keep a record of their non-protocol care appointments and participation in physical activities. After hospitalization, the patient will have to follow a multi-professional program: dietetic by a private dietician (at D3-J5, at 3 weeks and then at 6 weeks), medical by the general practitioner (at 1 month), and adapted physical activity by the EAPA (during 3 months). At three months, the patient will be seen again by the hospital's health professionals. The investigating physician will reassess nutritional status, and the EAPA will reassess physical capacity. The patient will be asked to return his diary so that data can be collected. They will also be given a quality of life and satisfaction questionnaire to complete. When all patients have completed their follow-up, a satisfaction questionnaire will be sent to each healthcare professional. Currently, as part of standard care, , dietetics and physical rehabilitation are not reimbursed. As a result, although recommended, patients rarely benefit from a dietetic consultation and adapted physical activity follow-up following a diagnosis of undernutrition. We therefore hypothesize that early cooperative outpatient care, involving general practitioners, private dieticians and adapted physical activity teachers (EAPA), for adult patients diagnosed as moderately or severely malnourished during hospitalization will optimize the management of these patients.

Interventions

• Other Dietary and physical activity monitoring during the 3-months post-hospitalization period
  Three consultations with a private dietician, one consultation with the general practitioner, three months of APA monitoring

Primary outcome measures

• Evaluate patient compliance with a new management program (dietetics and physical rehabilitation) for undernutrition on discharge from hospital [Time frame: Only once, at the 3 months follow-up]

Secondary outcome measures (12)

• Evaluate the patient's grip strength during the study [Time frame: Three times : At inclusion, at 1 month and 3 months after inclusion]
• Evaluate the speed of chair lifting during the study [Time frame: Three times : At inclusion, at 1 month and 3 months after inclusion]
• Evaluate the walking speed during the study [Time frame: Three times : At inclusion, at 1 month and 3 months after inclusion]
• Evaluate the patient's weight during the study [Time frame: Three times : At inclusion, at 1 month and 3 months after inclusion]
• Evaluate the patient's nutrition status during the study [Time frame: Twice : At inclusion and at 3 months after inclusion]
• Evaluate the patient's biological parameters during the study : phosphorus, magnesium, potassium, calcemia, corrected calcemia and transferrin-binding capacity [Time frame: Three times : At inclusion, at 1 month and 3 months after inclusion]
• Evaluate the patient's biological parameters relating to liver activity during the study : ASAT, ALAT, PAL, gamma-GT [Time frame: Three times : At inclusion, at 1 month and 3 months after inclusion]
• Evaluate the patient's biological parameters during the study : albumin, pre-albumin, CRP, ferritin [Time frame: Three times : At inclusion, at 1 month and 3 months after inclusion]
• Evaluate the patient's quality of life during the study by the EQ-5D-5L questionnaire. [Time frame: Three times : At inclusion, at 1 month and 3 months after inclusion]
• Evaluate end-of-study re-hospitalization and mortality rates [Time frame: Only once, at the 3 months follow-up]
• Evaluate patient satisfaction with their care at the end of the study [Time frame: Only once, at the 3 months follow-up]
• At the end of the study, assess patients' consumption of out-of-protocol care [Time frame: Only once, at the 3 months follow-up]

Eligibility criteria

Inclusion criteria

• Moderately or severely malnourished adult patient according to HAS diagnostic criteria: At least one phenotypic criterion: weight loss (> 5% in 1 month, > 10% in 6 months or relative to pre-disease weight), BMI < 18.5 in < 70 years or BMI < 22 in ≥ 70 years, reduced muscle mass and/or function AND At least one etiological criterion: reduction in food intake > 50% for > 7 days or > 14 days regardless of reduction, reduced absorption, aggressive situation with hypercatabolism
• Patient with an attending physician wishing to participate in the study
• Patient wishing to be followed by a private dietician participating in the study

Exclusion criteria

• Patients with cognitive disorders
• Patients with eating disorders
• Pregnant or breast-feeding patient
• Patient with an estimated life expectancy of less than 6 months (at investigator's discretion)
• Patient under legal protection
• Patient not affiliated to the social security system
• Patient who has not signed a free, written and informed consent form

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Health services research

Study locations

France · 1 center

• Centre hospitalier Henri Mondor d'Aurillac — Aurillac

Identifiers

NCT: NCT06976827 · RIPH2_VILANOVA_DENUTADOM · IDRCB : 2025-A00416-43

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗