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The Southampton Mealtime Assistance Roll-out Trial (SMART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02229019
Recruitment Status : Completed
First Posted : August 29, 2014
Last Update Posted : October 13, 2016
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
Medical Research Council
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Volunteer Mealtime Assistants Behavioral: Volunteer mealtime assistance Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Southampton Mealtime Assistance Roll-out Trial
Study Start Date : August 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229019


Locations
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United Kingdom
Southampton General Hospital
Southampton, Hampshire, United Kingdom, SO21 3BX
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust
National Institute for Health Research, United Kingdom
Medical Research Council
Investigators
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Principal Investigator: Fiona Rossiter, MBChB University Hospital Southampton NHS Foundation Trust

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital Southampton NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02229019     History of Changes
Other Study ID Numbers: MED1203
14/LO/1363 ( Other Identifier: London-Chelsea Research Ethics Committee )
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016

Keywords provided by University Hospital Southampton NHS Foundation Trust:
Volunteers
Mealtime assistance
Older adults
Nutrition
Nursing