- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01647204
Southampton Mealtime Assistance Study (SMAS)
Introduction of Mealtime Assistance Onto an Acute Medical Ward for Older People
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Poor nutritional status in older people acutely admitted to hospital is common with the risk of malnutrition estimated to be greater than 40%. Malnutrition is associated with major adverse clinical outcomes such as increased mortality, morbidity and length of stay at enormous cost to individuals and the health service. There is growing recognition that malnutrition is often unrecognised and untreated, and that many patients are discharged from hospital in a more malnourished state than when they were admitted. It is not surprising that complaints about nutrition and food services are amongst the commonest complaints in NHS hospitals.
The standard of mealtime care in UK hospitals has been an issue of concern for a number of years. A report last year from the Healthcare Commission found that one in five patients who wanted help eating did not get it. A secondary analysis of data provided by the Health Care Commission suggests that in some hospitals two out of five patients who wanted help with eating did not get it. Consistent with this, the recent Hungry to be Heard report found that nine out of ten nurses indicated they did not always have time to help ensure patients ate properly. They also suggested that some patients were not given appropriate assistance to eat. This problem is not unique to the UK and has been reported in other countries such as Australia and the USA.
The aim of the present study is to investigate if the use of volunteers employed specifically to focus on mealtime assistance in a Care of the Elderly Ward can increase food and nutrient intake, impact on body composition and improve clinical outcomes. The findings will inform service development in the nutritional care of older people across the Trust and wider.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hampshire
-
Southampton, Hampshire, United Kingdom, SO16 6YD
- University Hospital Southampton
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients will be recruited in a consecutive prospective manner.
- emergency admissions to acute medical wards and
- ability to gain consent from patient or relatives
Exclusion Criteria:
- Patient acutely unwell or palliative care
- Patient lacking capacity to consent and no assent given by relatives
- Patients who are tube fed or nil-by-mouth
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: usual mealtime care
patients admitted to the control ward receiving no intervention but usual mealtime help from ward staff
|
|
|
Experimental: mealtime assistance
Additional lunchtime help from trained volunteer mealtime assistants to supplement help from the ward staff
|
trained volunteers helped inpatients at lunchtimes with dinner tray preparation, encouragement and feeding if required
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mean dietary intake of inpatients during a 24 hour period
Time Frame: end of year 1 and year 2
|
The primary objective of the study is to determine if the use of volunteers employed specifically to focus on mealtime assistance can increase food and nutrient intake of patients admitted to an acute Care of the Elderly ward. Dietary intake measured as energy and protein |
end of year 1 and year 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
patient satisfaction
Time Frame: end of year 1 and year2
|
measured by patient interviews held during each year
|
end of year 1 and year2
|
|
malnutrition risk
Time Frame: end of year 1 and year2
|
MUST score will be abstracted from medical records
|
end of year 1 and year2
|
|
length of stay in hospital
Time Frame: end of year one and year two
|
taken from hospital records
|
end of year one and year two
|
|
grip strength
Time Frame: end of year 1 and year 2
|
measured using a dynamometer
|
end of year 1 and year 2
|
|
body composition
Time Frame: end of year one and year two and year 3
|
triceps and mid upper arm measurement
|
end of year one and year two and year 3
|
|
mortality
Time Frame: end of year 1 year 2 and year 3
|
abstracted from hospital records
|
end of year 1 year 2 and year 3
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Helen C Roberts, MB ChB, University of Southampton
Publications and helpful links
General Publications
- Roberts HC, Pilgrim AL, Jameson KA, Cooper C, Sayer AA, Robinson S. The Impact of Trained Volunteer Mealtime Assistants on the Dietary Intake of Older Female In-Patients: The Southampton Mealtime Assistance Study. J Nutr Health Aging. 2017;21(3):320-328. doi: 10.1007/s12603-016-0791-1.
- Roberts HC, Pilgrim AL, Elia M, Jackson AA, Cooper C, Sayer AA, Robinson SM. Southampton Mealtime Assistance Study: design and methods. BMC Geriatr. 2013 Jan 7;13:5. doi: 10.1186/1471-2318-13-5.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09/H0502/93
- RHM MED0882 (Other Identifier: UHS R&D ID)
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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