Volunteer Mealtime AssistantsSMARTNCT02229019
The Southampton Mealtime Assistance Roll-out Trial
A study testing Volunteer mealtime assistance in people with Volunteer Mealtime Assistants, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Volunteer Mealtime Assistants
- What is being tested?
- Volunteer mealtime assistance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients over the age of 70 years admitted to one of the wards under study
Who cannot join
- Patients with active bowel pathology
- Patients in the terminal phase of their life
- Patients who are artificially fed (parenterally or enterally)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Southampton General Hospital
Southampton, Hampshire, SO21 3BX
About this study
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.
- Conditions
- Volunteer Mealtime Assistants
- Being tested
- Volunteer mealtime assistance
- Keywords
- Volunteers, Mealtime assistance, Older adults, Nutrition, Nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volunteer mealtime assistanceBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Volunteer mealtime assistance | Experimental | Trained volunteers will provide mealtime assistance to older hospital inpatients at one mealtime each weekday. Receives: Behavioral: Volunteer mealtime assistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 months
Secondary outcomes (2)
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.
Measured: 16 months
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.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Volunteer Mealtime AssistantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Medical Research Council
- Responsible party
- Sponsor
- Investigators
- Fiona Rossiter, MBChB, Principal investigator, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229019
- Sponsor's protocol ID
- MED1203
- Other IDs
- 14/LO/1363
- Acronym
- SMART
- Status last verified
- Oct 2016
- First submitted
- 20 Aug 2014
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Howson FFA, Robinson SM, Lin SX, Orlando R, Cooper C, Sayer AAP, Roberts HC. Can trained volunteers improve the mealtime care of older hospital patients? An implementation study in one English hospital. BMJ Open. 2018 Aug 5;8(8):e022285. doi: 10.1136/bmjopen-2018-022285.
PubMed 30082361
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Southampton Mealtime Assistance Roll-out Trial
- ClinicalTrials.gov ID
- NCT02229019
- Acronym / sponsor ID
- SMART / MED1203
- Conditions
- Volunteer Mealtime Assistants
- Keywords
- Volunteers, Mealtime assistance, Older adults, Nutrition, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Medical Research Council
- Study start
- Aug 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 29 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volunteer mealtime assistance | Experimental | Behavioral: Volunteer mealtime assistanceTrained volunteers will provide mealtime assistance to older hospital inpatients at one mealtime each weekday. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients over the age of 70 years admitted to one of the wards under study
Key exclusion criteria (3 listed)
- Patients with active bowel pathology
- Patients in the terminal phase of their life
- Patients who are artificially fed (parenterally or enterally)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volunteer mealtime assistance | Behavioural | Volunteer mealtime assistance |
Primary outcome
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.
2 secondary outcomes
Changes in food choice and dietary intake before and after the introduction of volunteer mealtime assistants
Time frame: 16 months
Costs to the hospital trust associated with implementing a volunteer mealtime assistance programme
Time frame: 16 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- Derived from this study: PubMed 30082361Howson FFA, Robinson SM, Lin SX, Orlando R, Cooper C, Sayer AAP, Roberts HC. Can trained volunteers improve the mealtime care of older hospital patients? An implementation study in one English hospital. BMJ Open. 2018 Aug 5;8(8):e022285. doi: 10.1136/bmjopen-2018-022285.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiona Rossiter, MBChB principal investigator
University Hospital Southampton NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volunteer mealtime assistance in people with Volunteer Mealtime Assistants, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptability of volunteer mealtime assistants in different hospital departments (time frame: 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02229019, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2016.