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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02229019
Other study ID # MED1203
Secondary ID 14/LO/1363
Status Completed
Phase N/A
First received August 20, 2014
Last updated October 12, 2016
Start date August 2014
Est. completion date July 2016

Study information

Verified date October 2016
Source University Hospital Southampton NHS Foundation Trust.
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Institute for Health Research
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 258
Est. completion date July 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 70 Years and older
Eligibility 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
Volunteer mealtime assistance


Locations

Country Name City State
United Kingdom Southampton General Hospital Southampton Hampshire

Sponsors (3)

Lead Sponsor Collaborator
University Hospital Southampton NHS Foundation Trust. Medical Research Council, National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility and acceptability of volunteer mealtime assistants in different hospital departments 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 No
Secondary Changes in food choice and dietary intake before and after the introduction of volunteer mealtime assistants 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 No
Secondary Costs to the hospital trust associated with implementing a volunteer mealtime assistance programme 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 No