Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000611224
Ethics application status
Approved
Date submitted
20/07/2009
Date registered
22/07/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Helping to Understand Nutritional Gaps in the Elderly: An observational study to identify and prioritise risk factors for poor nutritional intake in hospitalised older adults
Scientific title
An observational study to identify and prioritise risk factors for poor nutritional intake in hospitalised older adults
Secondary ID [1] 280518 0
Nil
Universal Trial Number (UTN)
Trial acronym
HUNGER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition in hospitalised older adults 237299 0
Condition category
Condition code
Diet and Nutrition 239622 239622 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Not applicable - Observational study (measure nutritional intake and numerous suspected risk factors on day 3 and 7 of admission to hospital). Total study duration: 4 months.
Intervention code [1] 236975 0
Not applicable
Comparator / control treatment
Not applicable - Observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238407 0
Energy intake - 24hr dietary intake assessed by direct observation and plate waste methods, Foodworks software and known nutritional composition of standard serving sizes will be used to calculate energy intake.
Timepoint [1] 238407 0
24hr dietary intake data on day 3 and 7 of admission
Secondary outcome [1] 244883 0
Appetite - using the validated Simplified Nutritional Appetite Questionnaire.
Timepoint [1] 244883 0
Day 3 and 7
Secondary outcome [2] 244898 0
Dysphagia - using the validated Dysphagia Screening Tool
Timepoint [2] 244898 0
Day 3 and 7
Secondary outcome [3] 244899 0
Delirium - using the validated Confusion Assessment Method
Timepoint [3] 244899 0
Day 3 and 7
Secondary outcome [4] 244900 0
Depression risk - using the validated Geriatric Depression Scale
Timepoint [4] 244900 0
Day 3 and 7
Secondary outcome [5] 244901 0
Activities of Daily Living Dependency, including feeding dependency - using the validated Katz ADL index and feeding dependency question from the Modified Barthel Index.
Timepoint [5] 244901 0
Day 3 and 7
Secondary outcome [6] 244902 0
Nutrition risk and assessment - using validated screening tools (Malnutrition Screening Tool, Mini Nutritional Assessment) and assessment tools (Subjective Global Assessment, Mini Nutritional Assessment)
Timepoint [6] 244902 0
Day 3 and 7
Secondary outcome [7] 244903 0
Dentition - research assistant observation
Timepoint [7] 244903 0
Day 3 and 7
Secondary outcome [8] 244904 0
Patient characteristics (including age, gender, diagnosis, place of residence and discharge destination)
Timepoint [8] 244904 0
On admission and/or discharge.

Eligibility
Key inclusion criteria
65 years or older
Admitted to Internal Medicine study wards
Expected length of stay >3 days
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Palliative or terminal intent of admission Expected length of stay <3 days Transferred to another hospital ward/ treating team

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237359 0
Government body
Name [1] 237359 0
Queensland Health Strengthening Aged Care
Country [1] 237359 0
Australia
Funding source category [2] 237360 0
Charities/Societies/Foundations
Name [2] 237360 0
Royal Brisbane Women's Hospital Research Foundation
Country [2] 237360 0
Australia
Primary sponsor type
Individual
Name
Alison Mudge
Address
Department of Internal Medicine and Aged Care
Royal Brisbane and Women's Hospital Herston Qld 4029
Country
Australia
Secondary sponsor category [1] 236855 0
Individual
Name [1] 236855 0
Merrilyn Banks
Address [1] 236855 0
Department of Nutrition and Dietetics Royal Brisbane and Women's Hospital
Herston Qld 4029
Country [1] 236855 0
Australia
Other collaborator category [1] 776 0
Individual
Name [1] 776 0
Lynda Ross
Address [1] 776 0
Department of Nutrition and Dietetics Royal Brisbane and Women's Hospital
Herston Qld 4029
Country [1] 776 0
Australia
Other collaborator category [2] 777 0
Individual
Name [2] 777 0
Adrienne Young
Address [2] 777 0
Department of Nutrition and Dietetics Royal Brisbane and Women's Hospital
Herston Qld 4029
Country [2] 777 0
Australia
Other collaborator category [3] 778 0
Individual
Name [3] 778 0
Liz Isenring
Address [3] 778 0
School of Human Movement Studies
The University of Queensland
Brisbane QLD 4072
Country [3] 778 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239488 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 239488 0
Royal Brisbane and Women's Hospital Herston Qld 4029
Ethics committee country [1] 239488 0
Australia
Date submitted for ethics approval [1] 239488 0
Approval date [1] 239488 0
07/11/2007
Ethics approval number [1] 239488 0
2007/122

Summary
Brief summary
This study will try to identify and prioritise causes of poor intake in a representative older medical inpatient population. Approximately three hundred consecutive patients aged 65 years and over admitted to the general medical units at Royal Brisbane and Women’s Hospital will be studied. Information on potential causes of poor intake (identified from the literature and through expert clinical consultation) including poor appetite, swallowing difficulties, delirium, depression, dietary limitations, and need for feeding assistance will be collected on day 3 and 7 of the hospital stay. On each of these days, dietary intake will be determined.
Standard statistical modelling techniques will be used to identify which factors predict poor (<60% recommended) intake, after adjusting for important confounders such as age, sex and burden of illness.
These results will be supplemented by detailed interviews with a smaller selection of patients and their carers in order to ensure the patients experience is adequately represented in the research.
Trial website
Trial related presentations / publications
Mudge AM, Ross LJ, Young AM, Isenring EA, Banks MD. Helping understand nutritional gaps in the elderly (HUNGER): A prospective study of patient factors associated with inadequate nutritional intake in older medical inpatients. Clin Nutr. 2011 Jan 22;30(3):320-5.
Public notes

Contacts
Principal investigator
Name 29929 0
Address 29929 0
Country 29929 0
Phone 29929 0
Fax 29929 0
Email 29929 0
Contact person for public queries
Name 13176 0
Alison Mudge
Address 13176 0
Department of Internal Medicine and Aged Care
Royal Brisbane and Women's Hospital
Herston Qld 4029
Country 13176 0
Australia
Phone 13176 0
+61 7 3636 0507
Fax 13176 0
Email 13176 0
[email protected]
Contact person for scientific queries
Name 4104 0
Alison Mudge
Address 4104 0
Department of Internal Medicine and Aged Care
Royal Brisbane and Women's Hospital
Herston Qld 4029
Country 4104 0
Australia
Phone 4104 0
+61 7 3636 0507
Fax 4104 0
Email 4104 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.