- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02508974
Prevalence of Hospital Malnutrition in Adult Patients
31. maj 2018 opdateret af: Prof Renee Blaauw, University of Stellenbosch
Prevalence and Impact of Hospital Malnutrition on Associated Outcomes
Malnutrition of patients on admission to hospitals are estimated to be as high as 60%, although the prevalence varies between countries.
The impact of malnutrition on patient recovery and discharge is severe, with extensive cost implications.
This study aims to assess the prevalence of at risk for malnutrition among adult patients admitted to hospital across 3 countries on the African continent.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The prevalence of malnutrition on admission to hospital varies between 15-60%.
Knowing the extent of the problem and identifying at-risk patients should be a priority task since malnutrition is associated with increased hospital-related complications; longer length of stay, increased costs related to treatment and higher mortality.
Post discharge, malnourished patients have also been linked to more frequent re-admissions, higher morbidity and mortality.
Various screening tools are available, including the Nutrition Risk Screening-2002 recommended by European Society for Clinical Nutrition and Metabolism as the preferred screening tool for malnutrition in hospitals in Europe.
ASPEN recommends a more comprehensive evaluation and diagnosis procedure.
In South Africa, and the rest of Africa, nutritional screening is not routinely done and the investigators do not have any reliable national statistics indicating the extent of the problem.
The aim of this study is to determine the prevalence of malnutrition on admission to hospital and to identify the impact thereof on relevant outcomes.
Two different internationally recognised tools will be used and validated for the African context.
In this multi-country, multi-centre descriptive cross-sectional study 3 hospitals in South Africa, 1 in Ghana and 2 in Kenya will be included.
Adult patients (n=400 per hospital) will be screened on admission and at discharge and relevant outcomes (in-hospital and 3-month post-discharge) will be charted.
A 50% sub-sample will be used to validate the 2 instruments.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
2126
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Western Cape
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Cape Town, Western Cape, Sydafrika
- Tygerberg hospital
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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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
All adult patients admitted to the hospitals (3 in South Africa [Tygerberg Academic Hospital, Cape Town; Grootte Schuur Academic Hospital, Cape Town; Chris Hani Baragwanath Hospital, Johannesburg]; 2 in Kenya [Aga Khan University Hospital, Nairobi; Mbagathi district hospital, Nairobi] and 1 in Ghana [Korle Bu Teaching Hospital, Accra]) during the defined study periods will be eligible for inclusion in the study.
Beskrivelse
Inclusion Criteria:
- All patients older than 18 years of age
- Males and females
- Admitted to hospital within the past 48 hours
- Conscious
- Informed consent provided
Exclusion Criteria:
- Paediatric patients younger than 18 years
- Pregnant and lactating females
- Patients admitted to ICU, burns or relevant acute care wards
- Patients admitted to psychiatry or eating disorders units
- Patients on dialysis
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in prevalence of risk for malnutrition during the period of hospitalization
Tidsramme: Baseline; day 28
|
Baseline (Admission) data will be gathered during to the first 48 hours after hospital admission.
Discharge data (Day 28) is collected on day of actual discharge or on day 28 of hospitalization if patient is staying in hospital longer than that.
A NRS-2002 score greater than 3 indicates risk for malnutrition.
|
Baseline; day 28
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Association between risk for malnutrition and in-hospital and post-discharge nutritional / medical indicators
Tidsramme: Baseline; day 28 and Day 90
|
Baseline (Admission) data will be gathered during to the first 48 hours after hospital admission.
Discharge data (Day 28) is collected on day of actual discharge or on day 28 of hospitalization if patient is staying in hospital longer than that.
Post discharge data will be gathered 3 months after hospital discharge i.e. day 90 (again within a 48 hour period).
Nutritional indications refer to weight changes (gain or loss) and changes in appetite (improved, no change or decreased).
Medical indicators refer to nr of new complications requiring medical treatment, mortality or re-hospital admission.A NRS-2002 score greater than 3 indicates risk for malnutrition.
|
Baseline; day 28 and Day 90
|
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Number of patients obtaining similar screening scores as a measure of relative validity of the different screening tools used against each other
Tidsramme: Baseline and day 28
|
Baseline (Admission) data will be gathered during to the first 48 hours after hospital admission.
Discharge data (Day 28) is collected on day of actual discharge or on day 28 of hospitalization if patient is staying in hospital longer than that.
A good validity will be indicated by a sensitivity and specificity of more than 80%.
|
Baseline and day 28
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Renee Blaauw, PhD, University of Stellenbosch
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 (Faktiske)
1. januar 2015
Primær færdiggørelse (Faktiske)
1. december 2017
Studieafslutning (Faktiske)
1. december 2017
Datoer for studieregistrering
Først indsendt
27. maj 2015
Først indsendt, der opfyldte QC-kriterier
24. juli 2015
Først opslået (Skøn)
27. juli 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. juni 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. maj 2018
Sidst verificeret
1. maj 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- N14/06/061
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
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