|
ISRCTN
|
ISRCTN43554088
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Does intensive feeding improve nutritional status and outcome in acutely ill older in-patients?
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
RDC00891
|
|
Study hypothesis
|
Malnutrition has been estimated to cost the NHS £220 million a year because malnourished patients have longer hospital stays and increased morbidity. Malnutrition is particularly common in the elderly. Most intervention studies in this group have used liquid supplements but the results have been disappointing; even under surveillance, ill older patients often do not take enough supplement to improve their nutritional status. In routine clinical practice the situation is even worse because poor nutrition is often not recognised and compliance with supplements is even lower. Another approach is needed. This study examines whether health care assistants trained to provide support with all aspects of feeding can make a significant impact on nutritional intake and whether this improves outcome. The study is designed to determine: Does feeding support increase nutritional intake, lead to measurable changes in nutritional status (body mass index, arm circumference, serum albumin) and lead to improved outcome (infection rate, Barthel score, length of stay, readmission rate)?
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Acute illness
|
|
Participants - inclusion criteria
|
All patients over 65 admitted acutely to Medicine for the Elderly wards. Sample is estimate to be 750 people in each group.
|
|
Participants - exclusion criteria
|
1. Patients unable to take food orally (e.g. unconscious, severe dysphagia)
2. Not expected to survive the current admission
3. Patients with a body mass index (BMI) greater or equal to 25
|
|
Anticipated start date
|
01/12/1997
|
|
Anticipated end date
|
01/06/2000
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
1500
|
|
Interventions
|
1. Feeding support from health care assistants trained to provide support with all aspects of feeding
2. Standard care
|
|
Primary outcome measure(s)
|
The study is designed to see whether feeding support improves the nutritional status of patients to an extent it will have a positive day to day effect on function, the time patients require to become medically fit for discharge and length of stay.
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
NHS Executive London (UK)
|
|
Trial website
|
|
|
Publications
|
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/14757395
|
|
Contact name
|
Dr
Gary
Frost
|
|
Address
|
Hammersmith Hospital NHS Trust
Department of Nutrition and Dietetics
Hammersmith Hospitals NHS Trust
Ducane Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
W12 0HS
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 8383 3948
|
|
Fax
|
+44 (0)20 8383 3379
|
|
Email
|
Gfrost@hhnt.org
|
|
Sponsor
|
NHS R&D Regional Programme Register - Department of Health (UK)
|
|
Address
|
The Department of Health
Richmond House
79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Fax
|
+44 (0)20 7307 2623
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.doh.gov.uk
|
|
Date applied
|
23/01/2004
|
|
Last edited
|
12/01/2010
|
|
Date ISRCTN assigned
|
23/01/2004
|
