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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Evaluate patient compliance with a new management program (dietetics and physical rehabilitation) for undernutrition on discharge from hospital
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Evaluate patient compliance with a new management program (dietetics and physical rehabilitation) for undernutrition on discharge from hospital
时间窗: Only once, at the 3 months follow-up
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
次要结局
- 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)
- Evaluate the patient's biological parameters during the study : phosphorus, magnesium, potassium, calcemia, corrected calcemia and transferrin-binding capacity(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(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(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.(Three times : At inclusion, at 1 month and 3 months after inclusion)
- Evaluate end-of-study re-hospitalization and mortality rates(Only once, at the 3 months follow-up)
- Evaluate patient satisfaction with their care at the end of the study(Only once, at the 3 months follow-up)
- At the end of the study, assess patients' consumption of out-of-protocol care(Only once, at the 3 months follow-up)
- Evaluate the satisfaction of each professional involved (doctor, dietician, EAPA) in this protocol(Only once, at the study completion)
- Evaluate the medico-economic relevance of this new pathway for the early management of undernutrition(Only once, at the 3 months follow-up)