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Trial registered on ANZCTR


Registration number
ACTRN12622001469707
Ethics application status
Approved
Date submitted
18/02/2022
Date registered
21/11/2022
Date last updated
21/11/2022
Date data sharing statement initially provided
21/11/2022
Date results provided
21/11/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of an educational intervention (Senyumanis 'copyright') on dental clinic utilisation and glycaemic control in type 2 diabetic patients attending primary medical care clinics.
Scientific title
Effect of an educational intervention (Senyumanis 'copyright') on dental clinic utilisation and glycaemic control in type 2 diabetic patients attending primary medical care clinics: A randomised controlled trial.
Secondary ID [1] 306466 0
MRUN-RAKAN RU-2019-002/1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes mellitus 325323 0
Periodontal disease 325324 0
Condition category
Condition code
Metabolic and Endocrine 322712 322712 0 0
Diabetes
Public Health 322713 322713 0 0
Health promotion/education
Oral and Gastrointestinal 324591 324591 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
Senyumanis ('Copyright')
A web-based educational tool that can be assessed through http://senyumanis.my/.
It was developed by a team of researchers from Dental Faculty, National University of Malaysia (UKM) , based on literature on the use of the web-based educational tool in behavioral change in clinical settings. Also takes into consideration the work done by a dental team in oral health literacy among Malaysians and the expertise of team members with regards to technology-based education.
This oral health educational package has 2 sections included one section on diabetes, oral health, video on how to brush teeth properly and the bidirectional relationship between diabetes and periodontitis. This session took about 30 minutes on average per individual patient, given to patients during recruitment on their regular type 2 diabetes mellitus follow up at the clinics

A trained research assistant introduced and explained Senyumanis ('Copyright') to patients during the recruitment for the Senyumanis ('Copyright') group. The duration of study participation was 4 months.
Section 1: Optimum care for oral health, relationship between Type 2 diabetes mellitus and oral health. Section 2: Health assessment for risk of diabetes and periodontitis.
Following the session during recruitment, the patients were able to browse Senyumanis ('Copyright') on their own whenever they wanted to. Verbal feedback from patients gathered during exit visit regarding usage of the educational package.
Intervention code [1] 322904 0
Behaviour
Intervention code [2] 324321 0
Treatment: Other
Comparator / control treatment
Conventional care
Patients recruited under this arm were shown the self-educational pamphlet and posters by the Ministry of Health Malaysia which explained regarding oral health, diabetes mellitus and their relationship. This is in the form of hardcopy (A4 sized) posters, given to patients during recruitment, at their regular type 2 diabetes mellitus follow up visit
Control group
Active

Outcomes
Primary outcome [1] 330527 0
Fasting blood sugar and HbA1c will be analysed together as composite outcome
Timepoint [1] 330527 0
4 months post commencement of intervention during recruitment
Secondary outcome [1] 406527 0
Number of dental clinic visit appointments attended in last 4 months assessed by participant self-report
Timepoint [1] 406527 0
4 months post commencement of intervention during recruitment
Secondary outcome [2] 413421 0
frequency of brush teeth per day after intervention assessed by participant self-report
Timepoint [2] 413421 0
4 months post commencement of intervention during recruitment
Secondary outcome [3] 413422 0
Number of participants who did not visit a dentist post intervention and the reasons will be assessed as composite outcomes
Timepoint [3] 413422 0
4 months post commencement of intervention during recruitment

Eligibility
Key inclusion criteria
1. Adults aged 18 years old and above
2. Confirmed diagnosis Type 2 Diabetes Mellitus
3. Receiving standardised treatment as per Malaysian Clinical Practice Guidelines Ministry of Health
4. Understands spoken Malay or English language
5. Owns and able to operate a smartphone
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Patients with gestational diabetes mellitus (GDM)
2. Type 1 diabetes mellitus
3. Fully edentulous

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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)
Cluster randomisation
Clustering of intervention was done every three months. The flipped coin was used to decide 1st 3 months the participants received conventional care or Senyumanis ('Copyright'). After flipped coin, for the first three months, all patients recruited received conventional care and for the next three months, all patients recruited received Senyumanis('Copyright'). This is to avoid contaminations of sample as some participants had shorter follow up visit for their type 2 diabetes mellitus
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In terms of the first objective, regarding oral health practises among diabetes patients attending primary medical care clinics, the sample size was calculated using OpenEpi version 3, estimating sample size for frequency in a population at a 90% confidence level, the sample size needed is 243 diabetes patients as total attendance of diabetes patients in 6 months is expected to be 2327 patients.

As for the second objective, for the cluster-randomised study of Senyumanis ('Copyright') and conventional care, the sample size was calculated using Power & Sample Size Calculator, based on a power of 90% (ß=0.10), alpha of 0.05, an expected outcome difference of 25% between the 2 study interventions, the calculated sample size for each group is 40 patients. Allowing for a 20% dropout, a final sample size of 48 diabetes patients per group was used. A minimum total of 96 subjects was required for the sample size.

Therefore, in order to meet both objectives, a total of at least 243 type 2 diabetes patients were needed for this study, with at least 121 patients recruited per arm for Senyumanis ('Copyright') and conventional care.

Data analysis was carried out using Statistical Package Social Science (SPSS) version 26.0. For descriptive analysis of the study population, continuous data were reported using means and standard deviation (SD) for normally distributed data while categorical data were reported as frequencies and percentages. Bivariate analysis using independent t-test and Chi-square test were applied to compare profiles of patients and between Senyumanis ('Copyright') group and conventional care groups. Paired t-test was used to compare the clinic parameters i.e., FBS and HbA1c at baseline and post-intervention in both intervention group. In all tests, a p-value of <0.05 was considered to be statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/06/2020
Date of last participant enrolment
Anticipated
Actual
29/01/2021
Date of last data collection
Anticipated
Actual
31/05/2021
Sample size
Target
243
Accrual to date
Final
244
Recruitment outside Australia
Country [1] 24590 0
Malaysia
State/province [1] 24590 0
Kuala Lumpur and Pahang

Funding & Sponsors
Funding source category [1] 310815 0
Government body
Name [1] 310815 0
Malaysia Ministry of Higher Education
Country [1] 310815 0
Malaysia
Primary sponsor type
Individual
Name
Sarah Liyana M Abd Rani
Address
Department of Family Medicine
14th Floor, Preclinical Block
Faculty of Medicine
Universiti Kebangsaan Malaysia
Jalan Yaacob Latiff
Bandar Tun Razak, Cheras
56000 Kuala Lumpur
MALAYSIA
Country
Malaysia
Secondary sponsor category [1] 312060 0
Individual
Name [1] 312060 0
Associate Professor Dr Aznida Firzah Abdul Aziz
Address [1] 312060 0
Department of Family Medicine
14th Floor, Preclinical Block
Faculty of Medicine
Universiti Kebangsaan Malaysia
Jalan Yaacob Latiff
Bandar Tun Razak, Cheras
56000 Kuala Lumpur
MALAYSIA
Country [1] 312060 0
Malaysia
Secondary sponsor category [2] 312075 0
Individual
Name [2] 312075 0
Associate Professor Dr Tuti Ningseh Mohd Dom
Address [2] 312075 0
Department of Family Oral Health
Faculty of Dentistry, Universiti Kebangsaan Malaysia.
Jalan Raja Muda Abdul Aziz,
50300 Kuala Lumpur, MALAYSIA.
Country [2] 312075 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310382 0
Research and Ethics Committee of Universiti Kebangsaan Malaysia
Ethics committee address [1] 310382 0
Ethics committee country [1] 310382 0
Malaysia
Date submitted for ethics approval [1] 310382 0
Approval date [1] 310382 0
23/03/2020
Ethics approval number [1] 310382 0
UKM PPI/111/8/JEP-2020-150

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

Contacts
Principal investigator
Name 117458 0
A/Prof Aznida Firzah Abdul Aziz
Address 117458 0
Department of Family Medicine
14th Floor, Preclinical Block
Faculty of Medicine
Universiti Kebangsaan Malaysia
Jalan Yaacob Latiff
Bandar Tun Razak, Cheras
56000 Kuala Lumpur
MALAYSIA
Country 117458 0
Malaysia
Phone 117458 0
+6039145 6117
Fax 117458 0
+603 9145 9479
Email 117458 0
draznida@ppukm.ukm.edu.my
Contact person for public queries
Name 117459 0
Aznida Firzah Abdul Aziz
Address 117459 0
Department of Family Medicine
14th Floor, Preclinical Block
Faculty of Medicine
Universiti Kebangsaan Malaysia
Jalan Yaacob Latiff
Bandar Tun Razak, Cheras
56000 Kuala Lumpur
MALAYSIA
Country 117459 0
Malaysia
Phone 117459 0
+6039145 6117
Fax 117459 0
+603 9145 9479
Email 117459 0
draznida@ppukm.ukm.edu.my
Contact person for scientific queries
Name 117460 0
Aznida Firzah Abdul Aziz
Address 117460 0
Department of Family Medicine
14th Floor, Preclinical Block
Faculty of Medicine
Universiti Kebangsaan Malaysia
Jalan Yaacob Latiff
Bandar Tun Razak, Cheras
56000 Kuala Lumpur
MALAYSIA
Country 117460 0
Malaysia
Phone 117460 0
+6039145 5555
Fax 117460 0
+603 9145 9479
Email 117460 0
draznida@ppukm.ukm.edu.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results
When will data be available (start and end dates)?
Immediately following publication; no end date determined
Available to whom?
case by case basis at the discretion of the Primary Investigator
Available for what types of analyses?
to achieve aims in the approved proposal, for IPD meta-analyses.
How or where can data be obtained?
access subject to approvals by Principal Investigator


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15157Informed consent form  draznida@ppukm.ukm.edu.my 383600-(Uploaded-26-08-2022-12-52-24)-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
No additional documents have been identified.