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Cater With Care Effect Study (CwC)

11. november 2015 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

162

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Protein enriched products
The intervention group receives protein enriched products (CwC products) in the hospital and receives these also after discharge during 12 weeks.
Kosttilskud: 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.
Andre navne:
  • 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.
Kosttilskud: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline Protein intake and Physical functioning at 6 months
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in muscle strength from baseline to 6 months.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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

Andre resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Wageningen University

Efterforskere

  • Ledende efterforsker: Nicole M de Roos, PhD, Wageningen University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2014

Primær færdiggørelse (Faktiske)

1. oktober 2015

Studieafslutning (Faktiske)

1. oktober 2015

Datoer for studieregistrering

Først indsendt

7. august 2014

Først indsendt, der opfyldte QC-kriterier

8. august 2014

Først opslået (Skøn)

11. august 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. november 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. november 2015

Sidst verificeret

1. november 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NL48893.081.14

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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