- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02508974
Prevalence of Hospital Malnutrition in Adult Patients
May 31, 2018 updated by: 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.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Actual)
2126
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Western Cape
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Cape Town, Western Cape, South Africa
- Tygerberg Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in prevalence of risk for malnutrition during the period of hospitalization
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association between risk for malnutrition and in-hospital and post-discharge nutritional / medical indicators
Time Frame: 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
|
Number of patients obtaining similar screening scores as a measure of relative validity of the different screening tools used against each other
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Renee Blaauw, PhD, University of Stellenbosch
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
May 27, 2015
First Submitted That Met QC Criteria
July 24, 2015
First Posted (Estimate)
July 27, 2015
Study Record Updates
Last Update Posted (Actual)
June 1, 2018
Last Update Submitted That Met QC Criteria
May 31, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N14/06/061
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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