Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001031651
Ethics application status
Approved
Date submitted
3/09/2023
Date registered
22/09/2023
Date last updated
21/06/2024
Date data sharing statement initially provided
22/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Development, implementation and evaluation of the Spaced Retrieval and Montessori-based activities (SPREMON) mealtime intervention for individuals with dementia living in nursing homes: a pilot study
Scientific title
Effect of Spaced Retrieval and Montessori-based activities (SPREMON) mealtime intervention on eating difficulties, mealtime engagement and affect for individuals with dementia living in nursing homes
Secondary ID [1] 310201 0
None
Universal Trial Number (UTN)
U1111-1295-8109
Trial acronym
SPREMON: Spaced Retrieval and Montessori-based activities
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 330876 0
Eating difficulties 330877 0
Memory loss 330878 0
Condition category
Condition code
Neurological 327681 327681 0 0
Dementias
Diet and Nutrition 328220 328220 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Spaced Retrieval and Montessori-based activities (SPREMON) mealtime intervention consists of two components: Spaced Retrieval and Montessori-based activities. Spaced Retrieval is designed to enhance the memory of eating procedures in individuals with dementia. The eating skill sets include eating with knife and fork as well as eating with spoon, total of 10 eating steps.. Examples of the eating procedures include step 1, realizing it is mealtime; step 2, picking up a knife and fork; step 3, cutting the food into small bite-sized pieces; step 4, bringing the food to the mouth; step 5, chewing and swallowing; step 6, continuously eating the entire plate of food until feeling satisfied, and so on. The Montessori-based activities are designed to improve the motor skill of eating, include scooping, squeezing, pouring, cutting activities and small cooking activities for sensory stimulation. Each training session involves practicing one step of the eating procedure and engaging in one Montessori-based activity.

The SPREMON mealtime intervention consists of sessions lasting approximately 45 minutes, occurring three times a week for seven weeks, totaling 20 training sessions. These sessions will be conducted in person within a small group, typically consisting of 5 to 8 participants. Training materials such as knives, forks, spoons, plates, water jars, and cups will be provided, along with seasonal fruits and vegetables for small cooking activities. The intervention will take place in the residents' activity room at a not-for-profit nursing home in the Wollongong area of NSW, Australia. To monitor participants' adherence to the intervention, their attendance rate, response to the Spaced Retrieval, and participation in Montessori-based activities will be recorded. To reduce information bias, the intervention will be led by a researcher experienced in geriatric care and facilitated by one nursing home staff member consistently follow the intervention steps and procedures. .
Intervention code [1] 326624 0
Treatment: Other
Intervention code [2] 327013 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335510 0
The eating difficulties of individuals with dementia will be measured by the Edinburgh Feeding Evaluation in Dementia Questionnaire (EdFED-Q).
Timepoint [1] 335510 0
Prior to first intervention session, immediately after completion of the intervention program, and 3 months follow-up post-completion of the intervention program.
Primary outcome [2] 335511 0
The engagement and affect of individuals with dementia, measured by Engagement of a Person with Dementia Scale (EPWDS).
Timepoint [2] 335511 0
Prior to first intervention session, immediately after completion of the intervention program, and 3 months follow-up post-completion of the intervention program.
Secondary outcome [1] 424888 0
The memory of the eating procedure will be tested at each training session (45 minutes per session) at five different time intervals: an immediate test after introducing the eating procedure, a 4-minute, an 8-minute, a 16-minute, and a 32-minute test. A Spaced Retrieval Score Sheet will be used to record the outcomes.
Timepoint [1] 424888 0
The memory of the eating procedures will be tested at each training session (all sessions included) at five different time intervals: an immediate test after introducing the eating procedure, a 4 minute, an 8-minute, a 16-minute, and a 32-minute test.
Secondary outcome [2] 424889 0
The Engagement in Montessori-Based Activities Score Sheet will be used to collect participants' engagement in the Montessori-based activity data. The data will be recoded at the end of the training sessions,once only, all sessions included,
Timepoint [2] 424889 0
Participants' engagement in the Montessori-based activity data will be recoded at the end of each training session, once only, all sessions included,

Eligibility
Key inclusion criteria
• The person has a formal diagnosis of dementia (in early or moderate stages, with a
Mini-Mental State Examination score ranging from 10-23)
• Any individual with a score > 5 as measured by the EdFed-Q (Chang, 2012)
• Achieves a pass on the Spaced Retrieval Screening test
• Has a safe swallowing ability as determined by a Speech Pathologist or Registered
Nurse
• Can eat orally and use a knife, fork and spoon
• Able to sit in a chair for approximately 45 minutes, decided through consultation
with staff
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Individuals who cannot speak and understand English.
• Individuals who are not culturally and physically suitable for eating with knife and fork as well as eating with spoon training.
• A significant long-term mental health illness has been diagnosed.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to summarize the distribution of all variables. Continuous
variables (such as Spaced Retrieval score and Montessori-based activities score will be
collected from scales) will be presented as means, standard deviations (SD), and value ranges. To compare the differences intragroup, t-test or chi-square test will be used dependent on the distribution of the collected data. Categorical variables will be listed as frequencies and percentages and examine with non-parametric test. Regression analysis will be used to examine the effectiveness of intervention on outcomes. Cronbach’s alpha coefficient will be computed to examine the internal consistency of all scales. A p-value of less than 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/05/2024
Actual
6/05/2024
Date of last participant enrolment
Anticipated
12/08/2024
Actual
Date of last data collection
Anticipated
24/02/2025
Actual
Sample size
Target
35
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 314369 0
Commercial sector/Industry
Name [1] 314369 0
Warrigal nursing home, Wollongong site
Country [1] 314369 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Warrigal nursing home
Address
Shop 1/1 Ross St, Wollongong NSW 2500.
Country
Australia
Secondary sponsor category [1] 316319 0
None
Name [1] 316319 0
Address [1] 316319 0
Country [1] 316319 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313462 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 313462 0
Northfields Ave Wollongong, NSW 2522 Australia
Ethics committee country [1] 313462 0
Australia
Date submitted for ethics approval [1] 313462 0
01/09/2023
Approval date [1] 313462 0
30/04/2024
Ethics approval number [1] 313462 0
2023/268

Summary
Brief summary
This pilot study aims to examine the efficacy of the Spaced Retrieval and Montessori-based activities (SPREMON) mealtime intervention on eating difficulties, mealtime engagement, and affect in individuals with dementia living in an Australian nursing home. A quasi-experimental design (single group) will be undertaken for the pilot study. The pilot study will recruit 35 individuals who are in the mild to moderate stage of dementia, have eating difficulties, and scored above 5 on the Edinburgh Feeding Evaluation in Dementia Questionnaire. The intervention will consist of Spaced Retrieval and Montessori-based activities, 45 minutes per session, three times per week, for a total of 20 sessions over seven weeks. The outcomes will be measured three times: prior to first intervention session, immediately after completion of the intervention program and 3 months follow-up post-completion of the intervention program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128246 0
Prof Victoria Traynor
Address 128246 0
University of Wollongong, Innovation Campus. Level 2, Mike Codd building, Squires Way, North Wollongong NSW 2500.
Country 128246 0
Australia
Phone 128246 0
+61 2 4221 3471
Fax 128246 0
Email 128246 0
vtraynor@uow.edu.au
Contact person for public queries
Name 128247 0
Ms Zhoumei Yan
Address 128247 0
University of Wollongong, Innovation Campus. Level 2, Mike Codd building, Squires Way, North Wollongong NSW 2500.
Country 128247 0
Australia
Phone 128247 0
+61 426787428
Fax 128247 0
Email 128247 0
zy595@uowmail.edu.au
Contact person for scientific queries
Name 128248 0
Prof Victoria Traynor
Address 128248 0
University of Wollongong, Innovation Campus. Level 2, Mike Codd building, Squires Way, North Wollongong NSW 2500.
Country 128248 0
Australia
Phone 128248 0
+61 2 4221 3471
Fax 128248 0
Email 128248 0
vtraynor@uow.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data is co-share by the university of Wollongong and the Warrigal nursing home.


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.