- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05239442
Engaging Elderly People Living in Institutions in Eating Situations (ENGAGE)
Several recent studies have revealed a significant under-consumption of food in hospitals and nursing homes. For instance, at the Dijon University Hospital, 8 out of 10 patients consume less than 80% of the meals served. This has two consequences: an increase in the risk of malnutrition (some patients leave the hospital in such a poor nutritional state that they must be re-hospitalized within six months) and significant food waste. At the heart of this problem, the taste of the food is the subject of frequent and recurrent complaints from users. Although the food industry widely uses sensory methods to adapt its products to the taste of consumers, these methods are rarely used by the organizations that provide meals to care institutions.
The objective is to establish "taste commissions" in the daily practice in institutions for the elderly (hospital, nursing home), in order to improve the organoleptic quality of the meals served according to the expectations and preferences of the users. The principle of this system is to allow the users to taste the dishes produced by the kitchen of the establishment and to transmit these evaluations to the cooks so that they can rework the recipes according to the users' feedback.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Virginie VAN WYMELBEKE
- Número de teléfono: 03 80 29 31 55
- Correo electrónico: virginie.vanwymelbeke@chu-dijon.fr
Ubicaciones de estudio
-
-
-
Dijon, Francia, 21000
- Reclutamiento
- CHU Dijon Bourgogne
-
Contacto:
- Virginie VAN WYMELBEKE
- Número de teléfono: 03 80 29 31 55
- Correo electrónico: virginie.vanwymelbeke@chu-dijon.fr
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Hospitalized patients:
- Person hospitalized in one of the following departments: the endocrinology-diabetology department, geriatric medicine, pulmonology, rheumatology, dermatology, infectious diseases, internal medicine, cardiology, as well as the rehabilitation department, which are departments with an average length of stay sufficient to perform the study
- Person aged ≥ 50 years (this choice was made because more than 60% of the hospitalized population is currently over 50 years old)
- Person having given their oral agreement
- Person with an oral diet and eating without assistance
- Person with a normal texture diet
- For taste commissions and SWOT interviews: person with sufficient cognitive status to answer questions in a questionnaire or interview (MMSE > 21).
Residents in nursing home (EHPAD):
- Person residing in EHPAD
- Person aged ≥ 65 years
- Person having given oral consent
- Person who is orally fed and self-feeding
- Person with a normal texture diet
- For taste commissions and SWOT interviews: person with sufficient cognitive status to answer questions in a questionnaire or interview (MMSE > 21).
Facility staff for SWOT interviews:
- Person who has worked at the facility where the taste commissions were implemented at least 3 months previously.
- Person who gave oral consent
- Person between the ages of 18 and 60
Exclusion Criteria:
- Person at the end of life
- Person with an eating disorder
- Person with a significant chronic psychiatric disorder (psychosis, manic-depression).
- Person requiring enteral or parenteral nutrition.
- Person in a period of exclusion from a previous study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Patients
Hospital Patients: - Person hospitalized in one of the following departments: endocrinology-diabetology, geriatric medicine, pulmonology, rheumatology, dermatology, infectious diseases, internal medicine, cardiology, as well as in the rehabilitation department |
Evaluation of the daily meal once a week: Introduction on the different sensory dimensions of the food, hedonic rating for each component, indicate what pleases/what could be improved in the recipe. At 0, 3, 6 months:
|
|
Otro: Institutional staff
Person working in the establishment where the taste commissions have been in place for at least 3 months
|
Individual semi-guided face-to-face interview with an experimenter.
They will allow us to identify the positive and negative effects of the taste commissions in the establishment as well as the levers and difficulties encountered during the implementation of the taste commissions.
These interviews will be recorded using an audio device (dictaphone).
Their content will then be transcribed in full.
|
|
Otro: Residents
Patients residing in nursing home
|
Evaluation of the daily meal once a week: Introduction on the different sensory dimensions of the food, hedonic rating for each component, indicate what pleases/what could be improved in the recipe. At 0, 3, 6 months:
Individual semi-guided face-to-face interview with an experimenter.
They will allow us to identify the positive and negative effects of the taste commissions in the establishment as well as the levers and difficulties encountered during the implementation of the taste commissions.
These interviews will be recorded using an audio device (dictaphone).
Their content will then be transcribed in full.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
weight of consumed ingesta
Periodo de tiempo: Change from Baseline to 6 months
|
Change from Baseline to 6 months
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- VAN WYMELBEKE I-SITE 2017
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .