Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000181505
Ethics application status
Approved
Date submitted
14/12/2023
Date registered
26/02/2024
Date last updated
26/02/2024
Date data sharing statement initially provided
26/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Piloting the Modified Oral Health Assessment Tool and referral pathway in aged care
Scientific title
Piloting the Modified Oral Health Assessment Tool and referral pathway for acceptability and validity in aged care
Secondary ID [1] 310544 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
Preregistration for the co-design phase is available at https://osf.io/2kynu/

Health condition
Health condition(s) or problem(s) studied:
Oral health in residential aged care 332195 0
Condition category
Condition code
Oral and Gastrointestinal 328912 328912 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Public Health 328913 328913 0 0
Health service research
Public Health 329229 329229 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Oral Health Assessment Tool (OHAT) is designed for use in older adult populations. OHAT assesses the integrity of oral soft tissues and teeth, and saliva quality and quantity, oral cleanliness, and dental pain; and when referral to a dental practitioner is indicated. Assessment with the OHAT involves inspection of the mouth, teeth and oral tissues, and is approximately 10-15 minutes duration. It may be conducted by non-dentally trained staff.
The Modified-OHAT (M-OHAT) is an adapted tool based on the OHAT currently under development in co-design with residential aged care consumers and staff (https://osf.io/2kynu). Co-design activities will inform modifications and the development of the associated training package.
In this pilot study, residential aged care staff participants will be trained to implement the M-OHAT. The characteristics of the training will be devised based on recommendations arising from M-OHAT co-design with consumers and staff, including frequency and duration, and mode of administration. The training will be delivered by an oral health professional and adherence monitored through direct observation by the research team.
At T1 (assessment), resident participants will receive an M-OHAT assessment from 1) a trained staff participant; and 2) a qualified dental practitioner. Resident participants will also receive an oral epidemiological assessment by a dental practitioner, and receive referral to treatment based on the dental practitioner's assessment, where indicated.
Intervention code [1] 327511 0
Early detection / Screening
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336718 0
M-OHAT score (trainee)
Timepoint [1] 336718 0
T1 (at the time of the trainee M-OHAT assessment)
Primary outcome [2] 337066 0
M-OHAT score (expert)
Timepoint [2] 337066 0
T1 (at the time of the expert M-OHAT assessment)
Secondary outcome [1] 429429 0
Training acceptability (staff survey, developed for this study)
Timepoint [1] 429429 0
T0 (immediately post-training)
Secondary outcome [2] 429430 0
Assessment acceptability (staff survey, developed for this study)
Timepoint [2] 429430 0
T2 (immediately post-assessment, at least 1 assessment completed)
Secondary outcome [3] 429431 0
Referral uptake (resident telephone and/or records follow-up)
Timepoint [3] 429431 0
T3 (12 weeks post-assessment)
Secondary outcome [4] 430529 0
Assessment acceptability (resident survey, developed for this study)
Timepoint [4] 430529 0
T2 (immediately post-assessment)

Eligibility
Key inclusion criteria
Staff participants:
Work in a participating residential aged care facility
Have written permission from the aged care facility or participate during non-work time

Resident participants:
>=65 years of age (or >=55 years for people identifying as Aboriginal and/or Torres Strait Islander
Reside permanently in a participating residential aged care facility
Demonstrate capacity to give informed consent (i.e., score of 21 or greater on the Telephone Interview for Cognitive Status - Modified (TICS-M - Australian version) or other evidence of global capacity); OR provide consent through Enduring Power of Attorney (EPoA), Advance Health Directive (AHD), or other guardianship arrangement.

Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Staff participants:
<18 years old

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/04/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
25/04/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 314746 0
Government body
Name [1] 314746 0
Department of Health and Aged Care: Medical Research Future Fund
Country [1] 314746 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
UQ Oral Health Centre, 288 Herston Rd, Herston, Qld, 4006
Country
Australia
Secondary sponsor category [1] 316726 0
None
Name [1] 316726 0
Address [1] 316726 0
Country [1] 316726 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313756 0
Darling Downs Hospital and Health Service Human Research Ethics Committee (EC00182)
Ethics committee address [1] 313756 0
Ethics committee country [1] 313756 0
Australia
Date submitted for ethics approval [1] 313756 0
Approval date [1] 313756 0
16/10/2023
Ethics approval number [1] 313756 0
HREC/2023/QTDD/94702
Ethics committee name [2] 314333 0
UQ Human Research Ethics Committee (HABS LNR)
Ethics committee address [2] 314333 0
Ethics committee country [2] 314333 0
Australia
Date submitted for ethics approval [2] 314333 0
Approval date [2] 314333 0
18/05/2023
Ethics approval number [2] 314333 0
2023/HE000093

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

Contacts
Principal investigator
Name 129258 0
Prof Loc Do
Address 129258 0
UQ Oral Health Centre, The University of Queensland, 288 Herston Rd, Herston, Qld 4006
Country 129258 0
Australia
Phone 129258 0
+61 7 334 64828
Fax 129258 0
Email 129258 0
[email protected]
Contact person for public queries
Name 129259 0
Nicole Walker
Address 129259 0
UQ Oral Health Centre, The University of Queensland, 288 Herston Rd, Herston, Qld 4006
Country 129259 0
Australia
Phone 129259 0
+61 7 3365 8022
Fax 129259 0
Email 129259 0
[email protected]
Contact person for scientific queries
Name 129260 0
Nicole Walker
Address 129260 0
UQ Oral Health Centre, The University of Queensland, 288 Herston Rd, Herston, Qld 4006
Country 129260 0
Australia
Phone 129260 0
+61 7 3365 8022
Fax 129260 0
Email 129260 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21172Study protocol    Hosted on OSF or similar repository following comp... [More Details]
21173Analytic code    Hosted on OSF or similar repository prior to publi... [More Details]
21174Statistical analysis plan    Hosted on OSF or similar repository prior to publi... [More Details]
21175Informed consent form    Hosted on OSF or similar repository prior to publi... [More Details]



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.