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Cater With Care Effect Study (CwC)

11 novembre 2015 mis à jour par: Wageningen University

Effectiveness of Cater With Care Products in Reaching Recommendations for Protein Intake During and After Hospital Stay and in Improving Functional Status After Hospital Stay in Elderly Patients.

The objective is to study the effectiveness of supplementing a standard hospital and 12-week home menu with protein-enriched Cater with Care products in reaching a protein intake of 1,2-1,5 g/kg body weight/day and in improving functional status after hospital stay in elderly patients.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

Rationale: About 25% of hospitalized elderly patients are at risk of undernutrition at admission. Many hospitals provide an energy and protein enriched diet, extra snacks, and oral nutritional supplements if needed. Still, a considerable part of these patients are unable to meet protein requirements and are still at risk of undernutrition at hospital discharge. This may impair recovery of illness, partly due to loss of muscle mass and physical performance. To improve protein intake, Cater with Care products have been developed: a selection of foods and drinks that are consumed often by elderly persons, but now enriched with protein up to 10 grams per portion. We hypothesize that these products help to reach protein requirements in elderly patients during and after hospital stay and thereby improve their health outcomes.

Objective: To study the effectiveness of supplementing a standard hospital and 12-week home menu with protein-enriched Cater with Care products in reaching a protein intake of 1,2-1,5 g/kg/day and in improving functional status after hospital stay in elderly patients.

Study design: Randomised Controlled Trial (RCT) with 2 intervention groups and two phases: a hospital phase including all admitted patients and a home phase with a selection of patients.

Study population: Patients of 65 years or over who are admitted to the departments of Geriatrics, Pulmonary Disease, or Internal Medicine of Hospital Gelderse Vallei.

Intervention: The control group receives the standard hospital menu for elderly at risk of undernutrition (energy and protein rich) and a variety of foods and drinks to be used as part of their home diet for 12 weeks after hospitalization. Foods and drinks for home use are non-enriched variants of Cater with Care products (e.g. normal fruit juice).

The intervention group receives Cater with Care protein-enriched foods and drinks during hospital stay (in addition to the standard hospital menu) and at home as part of their home diet for 12 weeks.

Type d'étude

Interventionnel

Inscription (Réel)

162

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Pays-Bas
    • Gelderland
      • Ede, Gelderland, Pays-Bas, 6716 RP
        • Hospital Gelderse Vallei

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

65 ans et plus (Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Hospital phase:
  • admitted to the wards of Geriatric medicine, Pulmonary Medicine, or Internal Medicine in Hospital Gelderse Vallei
  • aged 65 years or over
  • being eligible for receiving a standard protein enriched menu based on hospital protocol
  • Home phase:
  • included in the hospital phase of the study
  • consent to continue treatment and study participation after hospital discharge

Exclusion Criteria:

  • Hospital phase:
  • unwilling to give consent for gathering data from the medical record or meal service system
  • unable to understand Dutch
  • food allergies, food intolerances or other dietary restrictions that prevents the patient from receiving the standard protein enriched menu or Cater with Care products based on the judgement of a dietician and/or medical staff
  • expected length of hospital stay less than 4 days
  • renal insufficiency (eGFR < 30 ml/min)
  • starting with tube feeding or total parenteral nutrition within 2 days of admission
  • refeeding syndrome score > 0 based on hospital screening tool for refeeding risk
  • delirium at admission
  • receiving palliative care
  • Home phase:
  • going to a nursing home, rehabilitation centre or hospice after hospital discharge
  • cognitive impairment or diagnosed with dementia
  • legally incapacitated

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Protein enriched products
The intervention group receives protein enriched products (CwC products) in the hospital and receives these also after discharge during 12 weeks.
Complément alimentaire: Protein enriched products
The intervention group receives CwC protein enriched products. After discharge the intervention group receives CwC products delivered at home for 12 weeks.
Autres noms:
  • CwC products
Comparateur actif: Usual menu
The control group receives the usual protein and energy rich menu in the hospital and receives regular products, no protein enrichment, after discharge during 12 weeks.
Complément alimentaire: Usual menu
The control group receives the usual menu, which is energy and protein rich in this elderly patient group. After discharge the control group receives regular products, no protein enrichment, at home for 12 weeks.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change from Baseline Protein intake and Physical functioning at 6 months
Délai: 6 months
This study has 2 primary outcomes: protein intake and physical functioning. These will be assessed at baseline (0), and 2, 6, 12 and 24 weeks after hospital discharge.
6 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in muscle strength from baseline to 6 months.
Délai: 6 months
Muscle strength (leg and hand grip) will be assessed at baseline (0), and 2, 6, 12 and 24 weeks after hospital discharge.
6 months
Change in nutritional status from baseline to 6 months.
Délai: 6 months
Nutritional status (MNA and dietary intake) will be assessed at baseline (0), and 2, 6, 12 and 24 weeks after hospital discharge.
6 months
Change in Quality of Life from baseline to 6 months.
Délai: 6 months.
Quality of Life will be assessed with the EuroQoL-5D-5L (at baseline, and 12 and 24 weeks after hospital discharge)
6 months.
Change in Activities of Daily Living from baseline to 6 months.
Délai: 6 months
Activities of Daily Living (ADL) will be assessed by using the Barthel index (at baseline, and 2, 6, 12 and 24 weeks after hospital discharge).
6 months

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
BMI
Délai: 6 months
BMI is calculated from weight and length measurements at baseline (0), 2, 6, 12, 24 weeks after hospital discharge.
6 months
Physical Activity
Délai: 6 months
Physical Activity will be assessed by using the LAPAQ questionnaire.
6 months
Length of hospital stay
Délai: 12 weeks
The length of hospital stay will be recorded to include in an economic evaluation.
12 weeks
Costs of hospital stay
Délai: 12 weeks
After discharge from the hospital, the costs of hospital stay will be calculated to include in the economic evaluation.
12 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Wageningen University

Les enquêteurs

  • Chercheur principal: Nicole M de Roos, PhD, Wageningen University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 octobre 2014

Achèvement primaire (Réel)

1 octobre 2015

Achèvement de l'étude (Réel)

1 octobre 2015

Dates d'inscription aux études

Première soumission

7 août 2014

Première soumission répondant aux critères de contrôle qualité

8 août 2014

Première publication (Estimation)

11 août 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

13 novembre 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 novembre 2015

Dernière vérification

1 novembre 2015

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NL48893.081.14

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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