Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000540213
Ethics application status
Approved
Date submitted
21/03/2018
Date registered
11/04/2018
Date last updated
14/03/2022
Date data sharing statement initially provided
5/04/2019
Date results provided
14/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Meaningful Engagement in Nutritional Understanding (MENU): Best choices for aged care
Scientific title
Meaningful Engagement in Nutritional Understanding: Using tailored education and a participatory approach to change awareness among aged care home staff of best nutrition care for residents living with dementia
Secondary ID [1] 294341 0
TCF35Medium00044
Universal Trial Number (UTN)
Trial acronym
MENU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nutrition 307061 0
Dementia 307062 0
Condition category
Condition code
Diet and Nutrition 306172 306172 0 0
Other diet and nutrition disorders
Neurological 306326 306326 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will facilitate Meaningful Engagement in Nutritional Understanding (MENU):
M Meaningful: Eating is an enjoyable social activity, not a task to be completed
E Engagement: Residents, family and staff in all positions at all levels collaborate to select
best-evidence care approaches tailored to their care home’s needs and preferences
N Nutritional: Systematic nutrition assessment is essential to monitor general health and
prevent infections that result in hospitalisation, and compromise brain and internal organ
function
U Understanding: Residents participate actively in their care and staff appreciate how daily
acts to support nutrition can make a vast difference and improve key function and
health indicators.

MENU involves a 10-month education-oriented intervention which incorporates a 4-month period of practice change implementation. Implementing MENU will involve residents, family, staff and care volunteers from two Tasmanian aged care homes working together to:
1. Workshop and select a number of ideas for change to nutrition care that are supported by evidence and suited to their care home (examples in List below),
2. Participate in tailored education facilitated by staff members who volunteer to work
together as Nutrition Champions to drive change, including mentoring and coaching staff (3/home),
3. Work with Nutrition Champions to implement these changes over four months, and
4. Assist with developing a short video to benefit care staff to distribute across Tasmania.

LIST. BEST-EVIDENCE NUTRITION CARE EXAMPLES
Staff/care volunteers/family sharing meals with residents
Family/buffet-style meals (e.g. residents choose food on table)
Reminiscence cooking sessions
Appropriate placement and prompts to eat/drink
Alternative meal choices (e.g. if less than half consumed)
Eating environment ambience (e.g. music)

Face-to-face workshops in each aged care home will run from 60-90 minutes and will involve the following key components:
Workshop 1
• Staff, care volunteers, family complete Nutritional Knowledge Questionnaire
• Discuss range of evidence-based strategies to facilitate nutritional health
• Identify Nutrition Champions for each care home
Workshop 2
• Discuss baseline findings
• Work collaboratively to select best evidence practices that suit each care home
• Education on best evidence care practices (e.g. 15 minute presentations each from dietitian and principal investigator; role-playing; discussion, partly facilitated by Nutrition Champions)
• Identify educational support materials for staff/family (e.g. posters, lanyard prompt cards)
Workshop 3
• Discuss progress & problem-solve any barriers, as will be mid-intervention
Workshop 4
• Re-administer Nutritional Knowledge Questionnaire
• Feedback and discussion on the intervention

Additional education of Nutrition Champions will involve a 90 minute face-to-face session, including a 30 minute presentation by a dietitian, 15 minute presentation by principal investigator, role-play, and discussion.

To monitor adherence to the 4-month period of practice change implementation, Nutrition Champions will conduct monthly ethnographic observation audits to assess care practices
Intervention code [1] 300647 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305181 0
Change in nutrition knowledge among aged care facility staff/care volunteers/family of best nutrition care for residents with dementia.
To measure this outcome, we will survey nutrition knowledge of staff/care volunteers/family (Nutritional Knowledge Questionnaire).
Timepoint [1] 305181 0
Measures will be repeated at the beginning and end of the 10-month education-oriented intervention.
Primary outcome [2] 305470 0
Change in nutrition care practices among aged care facility staff/care volunteers/family of best nutrition care for residents with dementia.
To measure this outcome, we will (a) review resident files for care practice changes, e.g. weight monitoring and (b) observe nutrition care practices, namely staff interactions with residents (e.g. language, practice, risk management) and observation of eating occasions in communal and private areas, including the physical environment (e.g. noise levels, presentation of food), food type, and level of feeding assistance - an itemised, open-ended observational record tool will be used to record these observations, developed from published literature.
Timepoint [2] 305470 0
Measures will be repeated before and after the 10-month education-oriented intervention.
Secondary outcome [1] 344441 0
Change in aged care facility residents’ malnutrition risk.
To measure this outcome, we will assess malnutrition risk using the Mini Nutritional Assessment 6-item tool.
Timepoint [1] 344441 0
Measures will be repeated before and after the 10-month education-oriented intervention.

Eligibility
Key inclusion criteria
Participants will be recruited from two aged care facilities where they will reside, work or volunteer, or be a family member of a resident.
The criteria for residents’ inclusion in the study are:
1. Resident in the aged care facility for over four weeks;
2. Has symptoms of cognitive impairment or dementia (e.g. over 9/21 on Psychogeriatric Assessment Scale–Cognitive (moderate-severe impairment)).
The criteria for aged care workers, care volunteers and family members are:
1. Has paid or voluntary employment at, or has a family member living in, one of the participating aged care homes;
2. Aged 18 year or over.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People highly dependent on medical care or, in the opinion of nursing staff, at end-of-life.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/07/2018
Actual
14/08/2018
Date of last participant enrolment
Anticipated
Actual
5/01/2021
Date of last data collection
Anticipated
Actual
16/03/2021
Sample size
Target
370
Accrual to date
Final
109
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 298985 0
Charities/Societies/Foundations
Name [1] 298985 0
Tasmanian Community Fund
Country [1] 298985 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Churchill Ave, Hobart TAS 7005
Country
Australia
Secondary sponsor category [1] 298282 0
None
Name [1] 298282 0
Address [1] 298282 0
Country [1] 298282 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299913 0
Tasmania Social Sciences Human Research Ethics Committee
Ethics committee address [1] 299913 0
Ethics committee country [1] 299913 0
Australia
Date submitted for ethics approval [1] 299913 0
02/02/2018
Approval date [1] 299913 0
08/03/2018
Ethics approval number [1] 299913 0
H0017136

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81970 0
Dr Emma Lea
Address 81970 0
Wicking Dementia Research and Education Centre | College of Health and Medicine
University of Tasmania
Medical Science 1 Building, 17 Liverpool St
Private Bag 143
Hobart TAS 7001
Country 81970 0
Australia
Phone 81970 0
+61 (0)3 6226 4217
Fax 81970 0
Email 81970 0
[email protected]
Contact person for public queries
Name 81971 0
Emma Lea
Address 81971 0
Wicking Dementia Research and Education Centre | College of Health and Medicine
University of Tasmania
Medical Science 1 Building, 17 Liverpool St
Private Bag 143
Hobart TAS 7001
Country 81971 0
Australia
Phone 81971 0
+61 (0)3 6226 4217
Fax 81971 0
Email 81971 0
[email protected]
Contact person for scientific queries
Name 81972 0
Emma Lea
Address 81972 0
Wicking Dementia Research and Education Centre | College of Health and Medicine
University of Tasmania
Medical Science 1 Building, 17 Liverpool St
Private Bag 143
Hobart TAS 7001
Country 81972 0
Australia
Phone 81972 0
+61 (0)3 6226 4217
Fax 81972 0
Email 81972 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Consent was not obtained from participants for their individual data to be available.


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.