Condition category
Not Applicable
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
12/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gary Frost

ORCID ID

Contact details

Hammersmith Hospital NHS Trust
Department of Nutrition and Dietetics
Hammersmith Hospitals NHS Trust
Ducane Road
London
W12 0HS
United Kingdom
+44 (0)20 8383 3948
Gfrost@hhnt.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RDC00891

Study information

Scientific title

Acronym

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

Acute illness

Intervention

1. Feeding support from health care assistants trained to provide support with all aspects of feeding
2. Standard care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 measures

Not provided at time of registration

Overall trial start date

01/12/1997

Overall trial end date

01/06/2000

Reason abandoned

Eligibility

Participant inclusion criteria

All patients over 65 admitted acutely to Medicine for the Elderly wards. Sample is estimate to be 750 people in each group.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

1500

Participant 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

Recruitment start date

01/12/1997

Recruitment end date

01/06/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Hammersmith Hospital NHS Trust
London
W12 0HS
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive London (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2004 results in http://www.ncbi.nlm.nih.gov/pubmed/14757395

Publication citations

  1. Results

    Hickson M, Bulpitt C, Nunes M, Peters R, Cooke J, Nicholl C, Frost G, Does additional feeding support provided by health care assistants improve nutritional status and outcome in acutely ill older in-patients?--a randomised control trial., Clin Nutr, 2004, 23, 1, 69-77.

Additional files

Editorial Notes