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

NCT06976827 | Not Yet Recruiting

• 2 other identifiers: RIPH2_VILANOVA_DENUTADOMIDRCB : 2025-A00416-43
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malnutrition Severe; Malnutrition; Moderate

Keywords

moderate malnutrition; severe malnutrition; ambulatory care; discharge from hospital

Outcome Measures

Primary Outcomes (1)

• Evaluate patient compliance with a new management program (dietetics and physical rehabilitation) for undernutrition on discharge from hospital

  Assessment of patient compliance with the innovative program will be based on their participation in the various consultations under the protocol (medical, dietary, physical rehabilitation), as well as in their adapted physical activity program. The clinical research associate in charge of the study will collect these data from the data transmitted by the professionals in charge of the patient's follow-up (physician, dietician, EAPA), as well as from the follow-up booklet completed by the patient. Adherence will be measured by analyzing deviations from consultations and APA sessions scheduled as part of the protocol, by category: * Medical: 2 scheduled consultations (attending general practitioner + hospital physician) * Dietetics: 3 consultations planned * Adapted physical activity: number of sessions varies according to the program defined by the EAPA

  Only once, at the 3 months follow-up

Secondary Outcomes (14)

• Evaluate the patient's grip strength during the study

  Three times : At inclusion, at 1 month and 3 months after inclusion

• Evaluate the speed of chair lifting during the study

  Three times : At inclusion, at 1 month and 3 months after inclusion

• Evaluate the walking speed during the study

  Three times : At inclusion, at 1 month and 3 months after inclusion

• Evaluate the patient's weight during the study

  Three times : At inclusion, at 1 month and 3 months after inclusion

• Evaluate the patient's nutrition status during the study

  Twice : At inclusion and at 3 months after inclusion

Study Arms (1)

After-hospital, care by a private dietician and a physical activity teacher

EXPERIMENTAL

For this study, there is only one arm. After hospital discharge, the patient will have multi-professional monitoring of his undernutrition: private dietician, adapted physical activity teacher and general practitioner.

Other: Dietary and physical activity monitoring during the 3-months post-hospitalization period

Interventions

Dietary and physical activity monitoring during the 3-months post-hospitalization period OTHER

Three consultations with a private dietician, one consultation with the general practitioner, three months of APA monitoring

After-hospital, care by a private dietician and a physical activity teacher

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier Henri Mondor d'Aurillac: lead

Study Sites (1)

Centre hospitalier Henri Mondor d'Aurillac

Aurillac, 15000, France

Location

MeSH Terms

Conditions

Malnutrition; Lymphoma, Follicular

Interventions

Diet

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 16, 2025
• Study Start: May 15, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

FR (1)