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Trial registered on ANZCTR


Registration number
ACTRN12621001359820
Ethics application status
Approved
Date submitted
3/09/2021
Date registered
8/10/2021
Date last updated
8/10/2021
Date data sharing statement initially provided
8/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Trial intervention of an oral device for the management of oral care and swallowing in an aged care population
Scientific title
Myofunctional device use in oral care and swallowing in an aged care population: A pilot feasibility study
Secondary ID [1] 305204 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysphagia (swallowing disorders) 323477 0
poor oral hygiene 323478 0
Condition category
Condition code
Oral and Gastrointestinal 321036 321036 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study aims to test procedures for acceptability and feasibility of a myofunctional device (MyoMunchee) in improving oral health and dysphagia in residents 65> years old in an aged care setting over a five week intervention period.

The Myofunctional Device (MyoMunchee ) has been approved by the Australian Government Department of Health (2019), Therapeutic Goods Administration as a medical device class 1 (low risk device), with intended purpose to exercise the jaw and surrounding muscles, as well as other conditions treated by oral motor therapy. The myofunctional device (MyoMunchee ) is ISO 13485 certified by the Standard for Quality Management System for design and manufacturing of medical devices, and is made of non-toxic medical grade silicone.

This will be a single intervention site study, conducted at an aged care facility in Newcastle, Australia, with data analysis occurring at the University of Newcastle, Australia.

Pre and post treatment outcome measures will be taken for comparison, and will be completed by the PhD student investigator who is qualified clinical speech pathologist (with over 17 years clinical experience) with reliability checking of 10% of residents onsite at the aged care facility by another qualified clinical speech pathologist from the University of Newcastle.

Before the intervention commences the student investigator will provide training to care staff (including nursing staff and allied health/speech pathology staff) on the device use, cleaning procedures for the device, and the intervention protocol.
Four training sessions will be available to staff. Each training session will be delivered face to face at the facility. The training session will be 60 minutes in duration and include practical demonstration of device use and cleaning. The training will also review guidelines and safe use of the device including monitoring of increased saliva production and clinical signs of aspiration, as well as data collection procedures.
Adherence to training will be monitored by the researcher weekly and will involve the collection of data sheets and informal discussions with care staff.

Care staff will provide one on one supervision/assistance to the aged care residents across the five week trial intervention with the device.
The myofunctional device (MyoMunchee ) will be used by the aged care resident twice daily (morning and evening recommended at the time of usual oral care routine) by the participants.
The use of the MyoMunchee involves the participant to place the device inside their mouth (similar to a mouth guard) and chew gently (similar to chewing gum or meat) for the specified time period as per the protocol. The duration for device use will start at 1 minute twice a day in the first week, and increase to 2 minutes twice a day in the second week, 3 minutes twice a day in the third week, 4 minutes twice a day in the fourth week, and 5 minutes twice a day use in the fifth week of intervention.

Adherence to treatment will be measure by way of daily checklist completion by the care staff, which will be collected at the end of each week and stored by the research team for the duration of the trial. Further to this a survey of the residents completing the intervention, as well as a questionnaire for the care staff assisting participants with the intervention will be taken at the completion of the five week intervention trial.

Intervention code [1] 321607 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328818 0
The feasibility of the treatment intervention will be measured by way of:
• The consenting rates - as determined of study enrolment logs, compared to number of residents that meet the selection criteria
Timepoint [1] 328818 0
Assessed at study completion
Primary outcome [2] 328819 0
Verbal survey of the residents receiving the intervention regarding experience using the device, using a 5-point Likert scale (very difficult – very easy), and dichotomous questions (yes – no)
Timepoint [2] 328819 0
Following the completion of the five week intervention
Primary outcome [3] 328820 0
Care staff (nursing/allied health) acceptability of assisting participants with the myofunctional device, as determined by care staff rating ease of assisting, cleaning, and time commitment on 5-point Likert scales.
Timepoint [3] 328820 0
Following the completion of the five week intervention
Secondary outcome [1] 400512 0
Oral Health Assessment Tool (OHAT) (Chalmers, Johnson, Tang, Titler, 2004)



Timepoint [1] 400512 0
Pre and post intervention (two weeks before intervention and no later than 2 weeks following the intervention)
Secondary outcome [2] 400513 0
Timed Water Swallowing Test (TWST) (Hughes &Wiles, 1996)
Timepoint [2] 400513 0
Pre and post intervention (two weeks before intervention and no later than 2 weeks following the intervention)
Secondary outcome [3] 400514 0
Test of Mastication and Swallowing Solids (TOMASS) (Huckabee, et al., 2018)
Timepoint [3] 400514 0
Pre and post intervention (two weeks before intervention and no later than 2 weeks following the intervention)
Secondary outcome [4] 400515 0
Mann Assessment of Swallowing Ability (MASA) (Mann, 2002)
Timepoint [4] 400515 0
Pre and post intervention (two weeks before intervention and no later than 2 weeks following the intervention)
Secondary outcome [5] 400516 0
Self perception of oral intake, as determined score obtained on the Eating Assessment Tool (EAT-10) (Belafsky, et al., 2008)
Timepoint [5] 400516 0
Pre and post intervention (two weeks before intervention and no later than 2 weeks following the intervention)
Secondary outcome [6] 400517 0
Cognitive capacity as determined by the Mini Mental State Examination (MMSE) (Malloy & Clarnette, 1999)
Timepoint [6] 400517 0
Pre and post intervention (two weeks before intervention and no later than 2 weeks following the intervention)
Secondary outcome [7] 400518 0
Functional Oral Intake Scale (FOIS) (Cary, Mann, & Groher, 2005)
Timepoint [7] 400518 0
Pre and post intervention (two weeks before intervention and no later than 2 weeks following the intervention)
Secondary outcome [8] 401364 0
Primary Outcome measure

Treatment completion rates - as determined by an audit of weekly data collection logs
Timepoint [8] 401364 0
Assessed at study completion
Secondary outcome [9] 401365 0
Primary Outcome Measure

• Treatment adherence - as determined by an audit of the data collection sheets
Timepoint [9] 401365 0
Assessed at study completion

Eligibility
Key inclusion criteria
Residents:
Inclusion criteria
1. age 65 years and above
2. Ability to understand English and follow instructions for timed water swallow test and use of the myofunctional device
3. Residents receiving texture modified diets and/or fluids
4. Residents with natural teeth, dentures (partial and full), and edentulous

Care staff (inclusive of nursing and allied health):
Inclusion criteria
1. Care staff at Aged Care Facility
2. Care staff approved by the Aged Care Facility to participate in the study
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Residents:
Exclusion criteria
1. Circumstances that interfere with the participant’s or guardian’s ability to give informed consent, for example, diminished understanding or comprehension, or a language other than English spoken.
2. Those who are on an end of life/palliative care pathway
3.Conditions that interfere with a patient's ability to comply with all treatment(s)/procedure(s) or follow study guidelines (such as behavioural issues as a result of Dementia)
4. Identified Temporomandibular Dysfunction
5. Those who are identified by the visiting oral health professional to have tooth mobility

Care Staff:
Exclusion criteria
1. Staff without nursing or allied health trained qualification

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
The number of participants that will be aimed for recruitment – 50 residents and 10 staff. This is based on the available recruitment pool, and the number of residents who may not give consent. Because this is a feasibility study this does not require sample size base.

Statistical analyses will be performed using SPSS, version 22. The primary outcome will be reported as numbers and percentages.
Secondary outcome measures will be summarised using mean (SD) for normally distributed data, median (interquartile range) for non-normally distributed data and number (percent for categorical data).
Pre- to post-treatment comparisons will be performed using a paired t-test. Effect size and 95% confidence interval will be reported. The significance level will be set at p<0.05.
In addition, for each of the secondary outcome measures, linear regression will be used to measure changes in secondary variables while controlling for age, cognition, adherence, comorbidities, and ability to implement the MyoMunchee independently.

Qualitative content analysis as described by Graneheim and Lundman (2004) will be used to analyse participants' responses on both the resident survey and care staff post intervention questionnaire.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/10/2021
Actual
Date of last participant enrolment
Anticipated
29/10/2021
Actual
Date of last data collection
Anticipated
24/12/2021
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20606 0
Maroba Aged Care - Waratah
Recruitment postcode(s) [1] 35231 0
2298 - Waratah

Funding & Sponsors
Funding source category [1] 309582 0
University
Name [1] 309582 0
University of Newastle
Country [1] 309582 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
MyoMunchee
Address
Level 1/62 Glebe Rd, The Junction NSW 2291
Country
Australia
Secondary sponsor category [1] 310597 0
None
Name [1] 310597 0
Address [1] 310597 0
Country [1] 310597 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309359 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 309359 0
Ethics committee country [1] 309359 0
Australia
Date submitted for ethics approval [1] 309359 0
16/07/2021
Approval date [1] 309359 0
30/09/2021
Ethics approval number [1] 309359 0
H-2021-0250

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

Contacts
Principal investigator
Name 113890 0
A/Prof Sally Hewat
Address 113890 0
Speech Pathology Department
University of Newcastle
University Drive, Callaghan
NSW, 2308
Australia
Country 113890 0
Australia
Phone 113890 0
+61249215159
Fax 113890 0
Email 113890 0
Sally.Hewat@newcastle.edu.au
Contact person for public queries
Name 113891 0
Sally Hewat
Address 113891 0
Speech Pathology Department
University of Newcastle
University Drive, Callaghan
NSW, 2308
Australia
Country 113891 0
Australia
Phone 113891 0
+61249215159
Fax 113891 0
Email 113891 0
Sally.Hewat@newcastle.edu.au
Contact person for scientific queries
Name 113892 0
Sally Hewat
Address 113892 0
Speech Pathology Department
University of Newcastle
University Drive, Callaghan
NSW, 2308
Australia
Country 113892 0
Australia
Phone 113892 0
+61249215159
Fax 113892 0
Email 113892 0
Sally.Hewat@newcastle.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
Only group data will be shared as per ethics approval


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13078Study protocol  Hollie-Ann.Shortland@newcastle.edu.au
13470Ethical approval    382708-(Uploaded-07-10-2021-16-58-39)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMyofunctional device use in oral care and swallowing: a protocol for a feasibility study in an aged care population.2022https://dx.doi.org/10.1186/s40814-022-01148-3
N.B. These documents automatically identified may not have been verified by the study sponsor.