Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-25 @ 5:34 PM
Study NCT ID:
NCT01647204
Status:
COMPLETED
Last Update Posted:
2014-11-04
First Post:
2012-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Southampton Mealtime Assistance Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 342}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-03', 'studyFirstSubmitDate': '2012-07-11', 'studyFirstSubmitQcDate': '2012-07-20', 'lastUpdatePostDateStruct': {'date': '2014-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean dietary intake of inpatients during a 24 hour period', 'timeFrame': 'end of year 1 and year 2', 'description': '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.\n\nDietary intake measured as energy and protein'}], 'secondaryOutcomes': [{'measure': 'patient satisfaction', 'timeFrame': 'end of year 1 and year2', 'description': 'measured by patient interviews held during each year'}, {'measure': 'malnutrition risk', 'timeFrame': 'end of year 1 and year2', 'description': 'MUST score will be abstracted from medical records'}, {'measure': 'length of stay in hospital', 'timeFrame': 'end of year one and year two', 'description': 'taken from hospital records'}, {'measure': 'grip strength', 'timeFrame': 'end of year 1 and year 2', 'description': 'measured using a dynamometer'}, {'measure': 'body composition', 'timeFrame': 'end of year one and year two and year 3', 'description': 'triceps and mid upper arm measurement'}, {'measure': 'mortality', 'timeFrame': 'end of year 1 year 2 and year 3', 'description': 'abstracted from hospital records'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nutrition', 'older', 'hospital', 'volunteer'], 'conditions': ['Malnutrition']}, 'referencesModule': {'references': [{'pmid': '28244573', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '23294981', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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. The sustainability of providing helpers to increase dietary intake over a year will be assessed and linked to actual dietary intake. The secondary objectives are to assess the association between dietary intake resulting from mealtime assistance and patient satisfaction, malnutrition risk, body composition, grip strength, length of hospital stay and hospital mortality.', 'detailedDescription': '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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients will be recruited in a consecutive prospective manner.\n\n* emergency admissions to acute medical wards and\n* ability to gain consent from patient or relatives\n\nExclusion Criteria:\n\n* Patient acutely unwell or palliative care\n* Patient lacking capacity to consent and no assent given by relatives\n* Patients who are tube fed or nil-by-mouth'}, 'identificationModule': {'nctId': 'NCT01647204', 'acronym': 'SMAS', 'briefTitle': 'Southampton Mealtime Assistance Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Southampton NHS Foundation Trust'}, 'officialTitle': 'Introduction of Mealtime Assistance Onto an Acute Medical Ward for Older People', 'orgStudyIdInfo': {'id': '09/H0502/93'}, 'secondaryIdInfos': [{'id': 'RHM MED0882', 'type': 'OTHER', 'domain': 'UHS R&D ID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'usual mealtime care', 'description': 'patients admitted to the control ward receiving no intervention but usual mealtime help from ward staff'}, {'type': 'EXPERIMENTAL', 'label': 'mealtime assistance', 'description': 'Additional lunchtime help from trained volunteer mealtime assistants to supplement help from the ward staff', 'interventionNames': ['Other: trained volunteer mealtime assistance']}], 'interventions': [{'name': 'trained volunteer mealtime assistance', 'type': 'OTHER', 'description': 'trained volunteers helped inpatients at lunchtimes with dinner tray preparation, encouragement and feeding if required', 'armGroupLabels': ['mealtime assistance']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SO16 6YD', 'city': 'Southampton', 'state': 'Hampshire', 'country': 'United Kingdom', 'facility': 'University Hospital Southampton', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'overallOfficials': [{'name': 'Helen C Roberts, MB ChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southampton'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Southampton NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Southampton', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}