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NCT06976827Not yet recruiting

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

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)

Source: ClinicalTrials.gov · Last updated 16 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
27 (estimated)
First submitted
29 Apr 2025
Start date
15 May 2025
Primary completion date
31 Dec 2025
Lead sponsor
Centre hospitalier Henri Mondor d'Aurillac
NCT number
NCT06976827

What you commit to

  • Study type: Interventional
  • Planned participants: 27
  • From 15 May 2025 to the primary completion date, 31 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with cognitive disorders
  • Patients with eating disorders

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre hospitalier Henri Mondor d'Aurillac
Coordinator of this site? Confirm its status
AurillacFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.