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Cater With Care Effect Study (CwC)

11 november 2015 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

162

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Nederländerna
    • Gelderland
      • Ede, Gelderland, Nederländerna, 6716 RP
        • Hospital Gelderse Vallei

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

65 år och äldre (Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Protein enriched products
The intervention group receives protein enriched products (CwC products) in the hospital and receives these also after discharge during 12 weeks.
Kosttillskott: 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.
Andra namn:
  • CwC products
Aktiv komparator: 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.
Kosttillskott: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from Baseline Protein intake and Physical functioning at 6 months
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in muscle strength from baseline to 6 months.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
BMI
Tidsram: 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
Tidsram: 6 months
Physical Activity will be assessed by using the LAPAQ questionnaire.
6 months
Length of hospital stay
Tidsram: 12 weeks
The length of hospital stay will be recorded to include in an economic evaluation.
12 weeks
Costs of hospital stay
Tidsram: 12 weeks
After discharge from the hospital, the costs of hospital stay will be calculated to include in the economic evaluation.
12 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Wageningen University

Utredare

  • Huvudutredare: Nicole M de Roos, PhD, Wageningen University

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2014

Primärt slutförande (Faktisk)

1 oktober 2015

Avslutad studie (Faktisk)

1 oktober 2015

Studieregistreringsdatum

Först inskickad

7 augusti 2014

Först inskickad som uppfyllde QC-kriterierna

8 augusti 2014

Första postat (Uppskatta)

11 augusti 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

13 november 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 november 2015

Senast verifierad

1 november 2015

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NL48893.081.14

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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