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Trial registered on ANZCTR


Registration number
ACTRN12617001357347
Ethics application status
Approved
Date submitted
4/09/2017
Date registered
27/09/2017
Date last updated
22/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Oral care intervention to reduce aspiration pneumonia risk for people living in residential aged care
Scientific title
Effect of sustained oral care intervention on incidence of aspiration pneumonia in adults with and without dementia living in residential care
Secondary ID [1] 292806 0
Nil known
Universal Trial Number (UTN)
U1111-1201-6623
Trial acronym
OCI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 304622 0
Aspiration pneumonia 304623 0
Oral health 304807 0
Quality of life 304808 0
Condition category
Condition code
Neurological 303938 303938 0 0
Dementias
Public Health 303939 303939 0 0
Health promotion/education
Respiratory 303940 303940 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 304104 304104 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
Name: Oral Health Intervention (for one participant group)
Oral health screening for all resident participants. Four measures to be delivered individually to participants in residential aged care by a dentist and a speech pathologist experienced in working with older adults, including adults with dementia. The measures, listed below, will take no longer than 1 hour:
(a) Oral Health Assessment Tool: "We will look at your face and lips and then ask you to open your mouth so we can look at your tongue, gums, oral tissues, teeth or dentures, and saliva to rate how healthy they are and whether you need any immediate and specific oral or dental care. We will shine a small light into your mouth so we can see. We also may place a soft wooden tongue depressor on the front of your tongue to keep it steady and gently hold your cheek to one side in the oral examination. If we hold your tongue and/or cheeks in place, we will do this for a short time, only seconds.
(b) Mini-Nutritional Assessment (MNA): We will ask you (or your family member, nurse or carer who knows you well) the following questions to determine your risk for being malnourished:
• Has your food intake declined over the past 3 months due to loss of appetite, digestive problems, chewing or swallowing difficulties?
• Have you lost weight unintentionally during the last 3 months?
• How easily are you able to get out of bed and move?
• Have you suffered psychological stress or acute distress in the past 3 months?
• Are you experiencing any neuropsychological problems such as depression and/or dementia?
• What is your height and weight so we can calculate your Body Mass Index (BMI)?
(c) Yale Swallow Protocol: We will give you a cup containing 90 mL (3 ounces) of room temperature water and ask you to drink the water through a straw without stopping. If you begin to cough while drinking, we will ask you to stop drinking. This measure helps us determine how well your swallow is coordinated and any risk for material (food, liquid, or saliva) going into your lungs instead of into your stomach.
(d) The Euro-Qol-5 Dimension (EQ-5D-3L) Tool: We will ask you (or a family member, nurse, or carer who knows you well) to rate any difficulty you have with mobility (movement), personal care, usual activities (e.g., housework or leisure activities), pain or discomfort, and anxiety or depression. Then we will ask you to draw a line on a scale (rather like a ruler or thermometer) to show us how good, or bad, you feel your health is."

All resident participants: Over a 3-month period, all resident participants will undergo 2 minutes of teething cleaning after each meal up to 3 times per day. Ideally the teeth cleaning will be done using a timed electric toothbrush. If residents cannot adjust to the sound or vibration of the electric toothbrush, we will develop 2-minute strategies for using a regular, soft bristled toothbrush, e.g., brushing to series of enjoyed and selected 2-minute recorded songs. If residents wear dentures, these dentures will be cleaned each day and removed for sleep. Residents will be encouraged to participate as actively as possible in cleaning their teeth or dentures, They will be assisted by care staff or family members to ensure this cleaning is done.
Adherence to the intervention will be assessed through audits of daily oral care by facility managers, including examination of used toothbrush heads/toothbrushes using a published standardized protocol..

Following the daily intervention period, all resident participants will undergo a repeat of the oral health screening measures.
Intervention code [1] 299051 0
Early detection / Screening
Intervention code [2] 299052 0
Prevention
Comparator / control treatment
No control group.
Residents will serve as their own controls through baseline data from pre-intervention screening being compared to repeat screening after the 3-month intervention period.
We may be able to have two groups of residents: (a) those with evident cognitive impairment or dementia, and (b) those with no evident cognitive impairment or dementia who live in the same residential aged care community.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303285 0
Change in instances of unexplained fever, as documented from residents' medical charts by each Facility Manager.
Timepoint [1] 303285 0
Instances during the six (6) months prior to the intervention commencement will be compared to instances throughout the three (3) month intervention period.
Primary outcome [2] 303286 0
Change in instances of chest and/or lung infections, as documented from residents' medical charts by each Facility Manager.
Timepoint [2] 303286 0
Instances during the six (6) months prior to the intervention commencement will be compared to instances throughout the three (3) month intervention period.
Primary outcome [3] 303287 0
Change in instances of unplanned hospital transfers or admissions to hospital related to clinical signs of aspiration pneumonia, as documented from residents' medical charts by each Facility Manager.
Timepoint [3] 303287 0
Instances during the six (6) months prior to the intervention commencement will be compared to instances throughout the three (3) month intervention period.
Secondary outcome [1] 338524 0
Proportion of participants with an improvement in oral health, as measured by
repeat screening with the Oral Health Assessment Tool
Timepoint [1] 338524 0
At 3 months after the daily oral care intervention
Secondary outcome [2] 338525 0
Proportion of participants with an improvement in nutritional health as measured by repeat screening with the MNA
Timepoint [2] 338525 0
At 3 months following the 3-month daily oral care intervention
Secondary outcome [3] 338526 0
Proportion of participants with an improvement in self-perceived quality of life, including overall health, as measured by repeat screening using the Euro-QOL-5D-3L measure
Timepoint [3] 338526 0
At 3 months following the daily oral care intervention period

Eligibility
Key inclusion criteria
All adults who live in the Fred French or Peace Haven residential aged care communities
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Inability to remain alert or to follow simple, 1-step directions
(2) Pre-existing dysphagia that prevents intake of thin liquids
(3) Head-of-bed is restricted to < 30 degrees
(4) Tracheotomy tube is present
(5) Doctor has ordered nothing by mouth (nil-per-os; NPO) for medical or surgical reasons
(6) Feeding tube inserted directly into the stomach is present.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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
This pilot study will assist in developing an appropriate power determination for future clinical trial studies. We will document instances of unexplained fever, chest and lung infections and other clinical signs of aspiration pneumonia, along with the number of unplanned hospital transfers/admissions related to clinical signs of aspiration pneumonia in the six (6) months prior to the 3-month intervention period, during the 3-month intervention period, and following 3-month intervention period.
Although the literature reports a range in prevalence rates for aspiration pneumonia for adults in residential care, current 12 month prevalence rates for aspiration pneumonia for adults with cognitive impairment or dementia average 61% when systematic oral health care is not in place. Given 120 residents (60 at each centre), we will anticipate that aspiration pneumonia (or clinical signs of this as it is often not diagnosed until hospitalization) affects up to 72 residents without intervention and that our intervention will reduce this number to 24 (a relative 33% reduction). Assuming a .05 significance level and a moderate effect size, we will have power of 85% for the study. This is feasible based on Japanese studies and accounts for any loss of residents due to death or relocation. We have ample power for the resident-related outcome measures. As an example, a 2-tailed paired t test evaluating the change in oral health of 60 residents, with a moderate effect size of .5, and a significance level of .05, yields a power of 97%.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/10/2017
Actual
6/12/2017
Date of last participant enrolment
Anticipated
31/01/2018
Actual
Date of last data collection
Anticipated
30/04/2018
Actual
Sample size
Target
120
Accrual to date
54
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment postcode(s) [1] 17317 0
7250 - Launceston

Funding & Sponsors
Funding source category [1] 297436 0
Government body
Name [1] 297436 0
NHMRC/NIDR/Dementia Centre for Research Collaboration
Country [1] 297436 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Wicking Dementia Research and Education Centre, Private Bag 143, Hobart, Tasmania 7001
Country
Australia
Secondary sponsor category [1] 296433 0
None
Name [1] 296433 0
Address [1] 296433 0
Country [1] 296433 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298545 0
No change in name of committee
Ethics committee address [1] 298545 0
Ethics committee country [1] 298545 0
Australia
Date submitted for ethics approval [1] 298545 0
04/09/2017
Approval date [1] 298545 0
04/12/2017
Ethics approval number [1] 298545 0
Number is H0016830

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2011 2011 0 0
/AnzctrAttachments/373588-Oral health study_Information Sheet for Residents and Staff.docx (Protocol)
Attachments [2] 2012 2012 0 0
/AnzctrAttachments/373588-Ethics Application_Oral Health_Project Description_August 30.docx (Other)
Attachments [3] 2013 2013 0 0
/AnzctrAttachments/373588-Oral health study_Informed Consent Form for Residents.docx (Participant information/consent)
Attachments [4] 2014 2014 0 0
/AnzctrAttachments/373588-Oral health study_Informed Consent Form for Staff.docx (Participant information/consent)

Contacts
Principal investigator
Name 77410 0
Dr Lynette Goldberg
Address 77410 0
Wicking Dementia Research and Education Centre
University of Tasmania
Private Bag 143
Hobart
Tasmania 7001
Country 77410 0
Australia
Phone 77410 0
+61 3 6226 6953
Fax 77410 0
Email 77410 0
Lyn.Goldberg@utas.edu.au
Contact person for public queries
Name 77411 0
Lynette Goldberg
Address 77411 0
Wicking Dementia Research and Education Centre
University of Tasmania
Private Bag 143
Hobart
Tasmania 7001
Country 77411 0
Australia
Phone 77411 0
+61 3 6226 6953
Fax 77411 0
Email 77411 0
Lyn.Goldberg@utas.edu.au
Contact person for scientific queries
Name 77412 0
Lynette Goldberg
Address 77412 0
Wicking Dementia Research and Education Centre
University of Tasmania
Private Bag 143
Hobart
Tasmania 7001
Country 77412 0
Australia
Phone 77412 0
+61 3 6226 6953
Fax 77412 0
Email 77412 0
Lyn.Goldberg@utas.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 373588-(Uploaded-26-11-2020-15-00-44)-Basic results summary.pptx
Plain language summaryNo From the initial screening (n = 142), 78% of resid... [More Details]

Documents added automatically
No additional documents have been identified.