The Southampton Mealtime Assistance Roll-out Trial (SMART)

October 12, 2016 updated by: University Hospital Southampton NHS Foundation Trust
The Southampton Mealtime Assistance Study aims to determine whether it is feasible and acceptable to introduce trained volunteers as mealtime assistants in five different departments of one large hospital.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

258

Phase

  • Not Applicable

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

  • United Kingdom
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO21 3BX
        • Southampton General Hospital

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

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients over the age of 70 years admitted to one of the wards under study

Exclusion Criteria:

  • Patients with active bowel pathology
  • Patients in the terminal phase of their life
  • Patients who are artificially fed (parenterally or enterally)

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

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Volunteer mealtime assistance
Trained volunteers will provide mealtime assistance to older hospital inpatients at one mealtime each weekday.
Behavioral: Volunteer mealtime assistance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility and acceptability of volunteer mealtime assistants in different hospital departments
Time Frame: 16 months

Is it feasible to recruit and sustain sufficient volunteers to provide mealtime assistance across a large hospital trust? Are these volunteers acceptable to patients, relatives, and staff? This will be determined by recording the number of volunteers recruited, trained and assessed and by recording their activity, in numbers of mealtimes assisted per week and duration of volunteering. If a volunteer discontinues their role, the reasons will be identified for this.

Acceptability will be assessed through qualitative methods- interviews with patients and relatives and focus groups with nursing staff and volunteers.
16 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in food choice and dietary intake before and after the introduction of volunteer mealtime assistants
Time Frame: 16 months
The food choices and dietary intake of patients on the wards under study will be determined twice prior to the introduction of the volunteers and twice after their introduction. This will take place at the mealtime where the volunteers are assisting. The weight of meals served is portion controlled by the hospital caterers to within 10% of the stated weight. Therefore, using these stated weights and by measuring the leftover weight of food, we will calculate each patient's dietary intake at that mealtime.
16 months
Costs to the hospital trust associated with implementing a volunteer mealtime assistance programme
Time Frame: 16 months
Staff costs in terms of time spent training and supporting volunteers will be recorded, as will any consumables required for the study. The costs will be totalled to provide an overall cost estimate of implementing a volunteer mealtime assistance programme.
16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Southampton NHS Foundation Trust

Collaborators

Medical Research Council
National Institute for Health Research, United Kingdom

Investigators

  • Principal Investigator: Fiona Rossiter, MBChB, University Hospital Southampton NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

August 20, 2014

First Submitted That Met QC Criteria

August 27, 2014

First Posted (Estimate)

August 29, 2014

Study Record Updates

Last Update Posted (Estimate)

October 13, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MED1203
  • 14/LO/1363 (Other Identifier: London-Chelsea Research Ethics Committee)

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.

Clinical Trials on Volunteer Mealtime Assistants

Clinical Trials on Volunteer mealtime assistance

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe