Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001171707p
Ethics application status
Submitted, not yet approved
Date submitted
23/08/2022
Date registered
29/08/2022
Date last updated
29/08/2022
Date data sharing statement initially provided
29/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
AWESSoM Care Home Project: effect of a novel programme on the oral health of care home residents and staff
Scientific title
AWESSoM Care Home Project: effect of oral health assessments and planning on oral health among care home residents and staff
Secondary ID [1] 307827 0
AWNSC 1911
Universal Trial Number (UTN)
Trial acronym
AWESSoM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor oral health 327433 0
Condition category
Condition code
Oral and Gastrointestinal 324556 324556 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
Element 1. Oral health care assessment and development of a preventive oral health care plan that aligns with the resident’s wishes, preferences and capacity for oral self-care. This will occur within 1 week after the participant's enrolment in the study. It will be delivered by by a registered oral health therapist/dental hygienist and will involve one session lasting one hour. Mode of delivery: face to face. The recommended preventive oral care materials will be selected from standard proprietary preventive and supportive oral care products, as appropriate for each participant. These might include 5,000ppm fluoride toothpaste (for tooth decay), oral moistening preparations (for dry mouth), adaptations to oral self-care aids such as toothpastes and interdental cleaning brushes. Adherence to the intervention will be determined through verbal confirmation at the end of the study.

Element 2. Single one-on-one preventive oral health care session with the participant and a nominated Wellness Partner, and if the participant wishes, a family or whanau member, to explain and demonstrate the oral hygiene care plan which arose from Element 1. Mode of delivery: face to face. It will be delivered by by a registered oral health therapist/dental hygienist and will occur 2-3 days after the initial assessment. It will take up to 1 hour.

Element 3. Support sessions (as necessary) with the oral health therapist/dental hygienist to encourage, motivate and assist resident and staff participants in the daily delivery of the oral hygiene care plan; and if indicated, referral to a dentist for acute pain or infection, or suspected malignancy, and/or recommendation to consult a dentist. The number of sessions required (and their periodicity) for each participant will be determined during Element 1 (above), because the intervention is tailored to participants' needs. Mode of delivery: face to face. Typically, there are likely to be 2-5 sessions (up to 10 if necessary), with sessions anticipated to be 10-30 minutes in duration. Support sessions will be available for no longer than 2 months after enrolment in the study. Adherence to the intervention will be monitored through verbal confirmation at the end of the study.



Intervention code [1] 324294 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332382 0
For residents:
Oral health status - measured using Locker's global item (as part of an oral health questionnaire)
Timepoint [1] 332382 0
At the time of study enrolment, and again two months after intervention commencement.
Primary outcome [2] 332393 0
Oral health-related quality of life, measured using the short-form Oral Health Impact Profile (OHIP-14)
Timepoint [2] 332393 0
Upon enrolment in the study and again two months after intervention commencement.
Primary outcome [3] 332394 0
Dry mouth symptoms, measured using the 5-item Summated Xerostomia Inventory (SXI) and a standard global dry mouth question.
Timepoint [3] 332394 0
At the time of study enrolment, and again two months after intervention commencement.
Secondary outcome [1] 413261 0
For staff: Oral health status - measured using Locker's global item (as part of an oral health questionnaire)
Timepoint [1] 413261 0
At the time of study enrolment, and again two months after intervention commencement.
Secondary outcome [2] 413323 0
For staff: Oral health-related quality of life, measured using the short-form Oral Health Impact Profile (OHIP-14)
Timepoint [2] 413323 0
At the time of study enrolment, and again two months after intervention commencement.
Secondary outcome [3] 413324 0
For staff: Knowledge and confidence in, and attitudes on, oral health and oral health care (both for older people and themselves), and in supporting dependent older people’s oral health care. Measured using questionnaire items included in a questionnaire designed specifically for this study.
Timepoint [3] 413324 0
At the time of study enrolment, and again two months after intervention commencement.
Secondary outcome [4] 413372 0
For staff: Oral self-care behaviours measured using a questionnaire developed for this study.
Timepoint [4] 413372 0
Upon enrolment into the study.
Secondary outcome [5] 413373 0
For staff: oral care support need, measured using a questionnaire developed for this study.
Timepoint [5] 413373 0
Upon enrolment in the study.
Secondary outcome [6] 413374 0
For staff: nature of referrals to oral and other health professionals (number, to whom and for what), measured using a questionnaire developed for this study.
Timepoint [6] 413374 0
Two months after enrolment into the study.
Secondary outcome [7] 413375 0
For staff: nature of interactions with on-site oral health therapist about residents’ or their own oral health care, measured using one-on-one semi-structured interviews..
Timepoint [7] 413375 0
Two months after enrolment into the study.
Secondary outcome [8] 413376 0
For staff: views on the acceptability, feasibility and sustainability of oral health care training and tools, the inclusion of oral health care in dependent older people’s care plans, including the provision of an on-site oral health professional and providing oral health care to dependent older people and oral health promotion activities in the workplace, measured one-on-one semi-structured interviews.
Timepoint [8] 413376 0
Two months after enrolment into the study.
Secondary outcome [9] 413377 0
For staff: views on the acceptability, feasibility and sustainability of providing oral health promotion activities in the aged care workplace, measured using one-on-one semi-structured interviews.
Timepoint [9] 413377 0
Two months after enrolment in the study.
Secondary outcome [10] 413429 0
For staff: Oral health need , measured using a questionnaire developed for this study.
Timepoint [10] 413429 0
At the time of study enrolment, and again two months after intervention commencement.
Secondary outcome [11] 413430 0
For staff: Use of oral health services, measured using a questionnaire developed for this study.
Timepoint [11] 413430 0
At the time of study enrolment, and again two months after intervention commencement.

Eligibility
Key inclusion criteria
Residents
• Receiving rest home, hospital, dementia or psychogeriatric-level support.
• Aged 65 years and over.
• Consents to participate.
Staff
• Employed on a permanent basis by the Care provider (not named here) to work in the care facilities involved, and providing and/or managing care for residents receiving rest home, hospital, dementia or psycho-geriatric-level.
• Consents to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Residents
• Receiving respite, palliative or end of life care.
• Extremely unwell or against medical advice.
• Do not consent to participate.
Staff
• Temporary/relief staff.
• Do not consent to participate.

Study design
Purpose of the study
Prevention
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
Pre-post-intervention design - this is essentially a feasibility study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data analysis will involve descriptive statistics, along with determining change scores and effect sizes for key outcome measures such as the OHIP-14 and SXI. The pilot nature of the project and the associated sample size constraints mean that there will be little emphasis on statistical significance (and in keeping with contemporary quantitative research practice).
Semi-structured interviews and focus group discussions will be recorded (with permission) and transcribed verbatim. The transcripts will be analysed using thematic analysis. The interview schedule will provide the initial framework to analyse the data, identifying emergent themes within categories. Additional questions that arise from interviews may be incorporated into the schedule for use in subsequent interviews
Approximately two months from their initial oral health therapist-led assessment and implementation of their care plan, participating residents and staff will undergo a second assessment to collect data and to provide feedback to the resident, staff and family or whanau on their progress.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/10/2022
Actual
Date of last participant enrolment
Anticipated
19/01/2023
Actual
Date of last data collection
Anticipated
14/04/2023
Actual
Sample size
Target
163
Accrual to date
Final
Recruitment outside Australia
Country [1] 24973 0
New Zealand
State/province [1] 24973 0
Wellington/Wairarapa

Funding & Sponsors
Funding source category [1] 312101 0
Government body
Name [1] 312101 0
National Science Challenges - Ageing Well (Ministry of Business, Industry and Employment)
Country [1] 312101 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
University of Otago Wellington
PO Box 7343
Newtown
Wellington 6242
New Zealand
Country
New Zealand
Secondary sponsor category [1] 313621 0
None
Name [1] 313621 0
Address [1] 313621 0
Country [1] 313621 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311504 0
Southern HDEC
Ethics committee address [1] 311504 0
Ethics committee country [1] 311504 0
New Zealand
Date submitted for ethics approval [1] 311504 0
28/07/2022
Approval date [1] 311504 0
Ethics approval number [1] 311504 0

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

Contacts
Principal investigator
Name 121330 0
Dr Moira B Smith
Address 121330 0
University of Otago Wellington
PO Box 7343
Newtown
Wellington 6242
Country 121330 0
New Zealand
Phone 121330 0
+64 21 476 099
Fax 121330 0
Email 121330 0
[email protected]
Contact person for public queries
Name 121331 0
Moira B Smith
Address 121331 0
University of Otago Wellington
PO Box 7343
Newtown
Wellington 6242
Country 121331 0
New Zealand
Phone 121331 0
+64 21 476 099
Fax 121331 0
Email 121331 0
[email protected]
Contact person for scientific queries
Name 121332 0
W. Murray Thomson
Address 121332 0
Faculty of Dentistry
University of Otago
PO Box 56
Dunedin 9054
Country 121332 0
New Zealand
Phone 121332 0
+64 21 279 7116
Fax 121332 0
Email 121332 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
Vulnerability of participants
Relatively small size of this feasibility study


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.