Does intensive feeding improve nutritional status and outcome in acutely ill older in-patients?

ISRCTN ISRCTN43554088
DOI https://doi.org/10.1186/ISRCTN43554088
Protocol serial number RDC00891
Sponsor NHS R&D Regional Programme Register - Department of Health (UK)
Funder NHS Executive London (UK)
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
12/01/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Gary Frost
Scientific

Hammersmith Hospital NHS Trust
Department of Nutrition and Dietetics
Hammersmith Hospitals NHS Trust
Ducane Road
London
W12 0HS
United Kingdom

Phone +44 (0)20 8383 3948
Email Gfrost@hhnt.org

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesMalnutrition 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedAcute illness
Intervention1. Feeding support from health care assistants trained to provide support with all aspects of feeding
2. Standard care
Intervention typeOther
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.

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/06/2000

Eligibility

Participant type(s)Patient
Age groupSenior
SexAll
Target sample size at registration1500
Key inclusion criteriaAll patients over 65 admitted acutely to Medicine for the Elderly wards. Sample is estimate to be 750 people in each group.
Key exclusion criteria1. 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
Date of first enrolment01/12/1997
Date of final enrolment01/06/2000

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Hammersmith Hospital NHS Trust
London
W12 0HS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2004 Yes No