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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02508974
Other study ID # N14/06/061
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2015
Est. completion date December 2017

Study information

Verified date May 2018
Source University of Stellenbosch
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 2126
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
South Africa Tygerberg Hospital Cape Town Western Cape

Sponsors (1)

Lead Sponsor Collaborator
University of Stellenbosch

Country where clinical trial is conducted

South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in prevalence of risk for malnutrition during the period of hospitalization 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
Secondary Association between risk for malnutrition and in-hospital and post-discharge nutritional / medical indicators 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
Secondary Number of patients obtaining similar screening scores as a measure of relative validity of the different screening tools used against each other 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
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