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Trial registered on ANZCTR


Registration number
ACTRN12619001725156
Ethics application status
Approved
Date submitted
19/08/2019
Date registered
6/12/2019
Date last updated
6/12/2019
Date data sharing statement initially provided
6/12/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of Diabetes Health Literacy Intervention Based on Social Cognitive Theory on Glycaemic Control among Type 2 Diabetes Mellitus Patients in Kuala Selangor District Malaysia
Scientific title
Effectiveness of Diabetes Health Literacy Intervention Based on Social Cognitive Theory on Glycaemic Control among Type 2 Diabetes Mellitus Patients in Kuala Selangor District Malaysia
Secondary ID [1] 297564 0
None
Universal Trial Number (UTN)
U1111-1229-3520
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 311811 0
Condition category
Condition code
Metabolic and Endocrine 310417 310417 0 0
Diabetes
Public Health 310418 310418 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The content of the intervention module will mainly be adapted from “Partner to Improve Diabetes Education” (PRIDE) (permission has been granted from the owner from Vanderbilt University). However, this module will be tailored to the needs of the community, cultural sensitivity, diet and diabetic treatment of Malaysian people specifically in a rural area. The module content focus was based on Social Cognitive Theory approach as its theoretical framework. The intervention education will be held for about one month. The intervention session will be in a group format, coordinate and facilitate by the trained (diabetic education) post-graduate students who are not part of the research team at the selected health clinics. The intervention language will be in Bahasa Malaysia The intervention will focus on empowerment of respondents to change their lifestyle, behaviour and glycaemic control by improving their health literacy on Type 2 Diabetes Mellitus based on the adapted “Partner to Improve Diabetes Education” (PRIDE) module.
This intervention will incorporate general information about diabetes, diabetes nutrition information, diabetes medication treatment, lifestyle management, behaviour changes and foot care. In addition, the participants also will be given Malaysia Healthy Plate (quarter-quarter half) and diabetes self-management flip chart as take-home materials for their own references. The take-home material (flip chart) will be printed in Bahasa Malaysia.
All intervention sessions will be conducted in a group of 6-8 respondents at a private room in a health clinic and will be conducted by one trained (diabetic education) post-graduate students. In a group, the trained postgraduate will explain about the diabetes self-management and open a conversation with the respondents for discussion.
The whole intervention process would take about half-day (4 hours) for each respondent consists of 2 sessions, each session will take about 2 hours. Food and beverages will be provided to minimized discomfort to the respondents.
Session 1 (2 hours) consists of:-
1) general information about diabetes
2) diabetes nutrition information
3) diabetes medication treatment
Session 2 (2 hours) consists of:-
1) lifestyle management
2) behaviour changes
3) foot care
For this research, I will be teaching the module with the help of trained (diabetic education) post-graduate students. No treatment will be given to the respondents except they will continue with their own medication.
For the followup sessions, it will be held in 2 times:-
1) After 3 months of intervention
- Assessing respondent knowledge by using the same questionnaire at baseline.
- Take respondent latest HbA1c reading.
2) After 6 months post-baseline
- Assessing respondent knowledge by using the same questionnaire at baseline.
- Take respondent latest HbA1c reading.
For the duration of the followup session, it may take about 40 minutes - 1 hour for each participant.
Intervention code [1] 315870 0
Lifestyle
Intervention code [2] 315871 0
Behaviour
Intervention code [3] 315872 0
Treatment: Other
Comparator / control treatment
The control group will continue their diabetic education receive from diabetic health clinic at Tanjong Karang Health Clinic. The module used is based on the Ministry of Health Malaysia. The session will consist of diet, medication adherence and exercise. It will be delivered verbally in Bahasa Malaysia. No take-home material or booklet will be given. The teaching session will be held at Tanjong Karang Health Clinic. It will be 2 hours session for every two weeks in a month. The respondents are selected from their diabetic patient's list from the health clinic.
Control group
Active

Outcomes
Primary outcome [1] 321113 0
Changes in glycaemic control (HbA1c)
Timepoint [1] 321113 0
1) Baseline
2) At 3 month post-intervention
3) At 6 month post-baseline
Secondary outcome [1] 374033 0
Health Literacy Score (HLS-EU-Q47 toolkit)
Timepoint [1] 374033 0
1) Baseline
2) At 3 month post-intervention
3) At 6 month post-baseline
Secondary outcome [2] 374034 0
Diabetes Quality of Life (DQoL)
Timepoint [2] 374034 0
1) Baseline
2) At 3 month post-intervention
3) At 6 month post-baseline

Eligibility
Key inclusion criteria
Inclusion criteria:-
i) Diagnosed as Type 2 Diabetes Mellitus patient for more than 3 months.
ii) Adult (Age 18 and above)
iii) At least received one type of drug treatment.
iv)Baseline HbA1c is more or equal to 6.5%.
v) Able to understand Bahasa Malaysia
vi) Agree to participate in this study
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:-
i) Diabetic patient with advances complication such as:-
a. Microvascular complications (nephropathy, retinopathy and neuropathy)
b. Macrovascular complications (atherosclerosis and stroke)
ii) A patient diagnosed by attending doctor
a. Psychological illness
b. Hearing and vision impairment
c. Uses illicit drugs
iii) Non-Malaysia Citizen

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The formula for calculating sample size in hypothesis testing by comparing means was used (Lwanga, Lemeshow, & Organization, 1991). Two population mean formula is used due to comparing two groups for hypothesis testing. This is based on a patient's HbA1c level difference pre and post-intervention between control and intervention group with a response rate of 90%
Where,
N = Sample size
2s2 = estimated standard deviation (assumed to be equal for each group) is 16.7
??1 - a/2 = Z statistics for level of 95% confidence = 1.96
??1 – ß = Z statistics for 80% power =0.842
µ1 = estimated mean HbA1c reading after the intervention is 72.88 (Protheroe et al., 2016)
µ2 = estimated mean HbA1c reading for the control group is 66.19 (Protheroe et al., 2016)
By substituting the values using the above formula, we can have the calculation sequence as follows:
N = 2(16.7)2 [1.96+0.842]2 / (72.88 – 66.19)2
= 558.44 [7.851204] / 44.75
= 4384.42 / 44.75
N = 97.9 ˜ 98
Based on the above formula, the required minimum sample size for each group, n is 98.
After adjusting for 20% of non-response rate
N = 98 / 0.8
= 122.5 ˜ 123 particpants (for 1 group)
Participants in intervention group =123
Participants in control group = 123
TOTAL participants overall study = 246

Statistical analysis:-
Statistical analysis will be performed using IBM Statistical Package for Social Science (SPSS) for windows version 23.0. The purpose of these analyses is to answer all the research questions (HbA1c level, health literacy, quality of life, physical activity, knowledge and self-efficacy constructs of social cognitive theory). The level of significance for all statistical test will be set at alpha less than 0.05. Odds numbers will be allocated for the intervention group, so they represent the responses and score of participants in the intervention group, whereas even number will be allocated for the control group, as they represent the responses and scores of participants in the control group.
The researcher will verify the accuracy of data entry with the help of a professional statistician. Descriptive and inferential analyses will be analysed in this research.
Descriptive results will be presented as:-
1)mean
2)median
3)frequency
4)percentage
Inferential statistics will be utilized where appropriate
The confidence interval will be set at 95% for the estimation mean. The level of significance will be set at p less than 0.05. To access comparability of the intervention and control during baseline, Chi-square will be used in categorical data whereas independent T-test will be used in continuous data.
Data analysis will be done in different stage. within-subject analysis and between-subject analyses. A repeated measure ANOVA will be used to compare the difference between and within the intervention group and control group from baseline to post-intervention. Multivariate analysis of covariance (MANCOVA) will be used to compare the difference between and within intervention group and control group from baseline to post-intervention after controlling for covariates sociodemographic characteristics (age, gender, ethnic and marital status), socioeconomic characteristics (income status, education background and occupation) and medical profiles (types of medication and duration of having Type 2 Diabetes Mellitus).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
17/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
246
Accrual to date
150
Final
Recruitment outside Australia
Country [1] 21777 0
Malaysia
State/province [1] 21777 0
Selangor / Kuala Selangor District (Tanjong Karang)

Funding & Sponsors
Funding source category [1] 302116 0
Government body
Name [1] 302116 0
Fundamental Research Grant Scheme (FRGS), Ministry of Higher Education Malaysia (MoHE)
Country [1] 302116 0
Malaysia
Funding source category [2] 303606 0
University
Name [2] 303606 0
Universiti Putra Malaysia (UPM)
Country [2] 303606 0
Malaysia
Primary sponsor type
Government body
Name
Fundamental Research Grant Scheme (FRGS), Ministry of Higher Education Malaysia (MoHE)
Address
Bahagian Perancangan Kecemerlangan IPT, Jabatan Pendidikan Tinggi, Kementerian Pendidikan Tinggi,
Aras 7, No.2 Menara 2, Jalan P5/6, Presint 5, 62200 Putrajaya, Malaysia
Country
Malaysia
Secondary sponsor category [1] 301949 0
University
Name [1] 301949 0
Universiti Putra Malaysia (UPM)
Address [1] 301949 0
Department of Community Health,
Faculty of Medicine and Health Sciences,
Universiti Putra Malaysia,
43400 Serdang, Selangor Darul Ehsan
MALAYSIA
Country [1] 301949 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302797 0
The Medical Research and Ethics Committee (MREC), Ministry of Health Malaysia (MOH)
Ethics committee address [1] 302797 0
Jawatankuasa Etika dan Penyelidikan Perubatan (Medical Research & Ethics Committee)
KEMENETERIAN KESIHATAN MALAYSIA
d/a Institut Pengurusan Kesihatan
Jalan Rumah Sakit, Bangsar,
59000 Kuala Lumpur
MALAYSIA
Ethics committee country [1] 302797 0
Malaysia
Date submitted for ethics approval [1] 302797 0
28/03/2018
Approval date [1] 302797 0
13/04/2018
Ethics approval number [1] 302797 0
NMRR-15-2490-28108 (IIR)

Summary
Brief summary
Type 2 Diabetes Mellitus (T2DM) has become one of the most serious global health problems nowadays. Thus, numerous T2DM patients have limited health literacy, which likely leads to poor clinical outcomes such as poor glycaemic control. However, high-quality health literacy targeted education program probably have a profound effect on the health outcomes of the targeted group and enhance better glycaemic control.

This is a randomised controlled trial which patient diagnosed with T2DM, 18 years and above, from a health clinic in Kuala Selangor District will be randomised into two groups either intervention or control group. A validated structured questionnaire will be used for data collection. Data will be collected from baseline, 3 months post-intervention and 6 months post-baseline.

The intervention programme sessions will be in a group format, coordinate and facilitate by the trained postgraduate student, the session will cover general information about T2DM, nutrition information, diabetes medication, lifestyle management and behaviour change and foot care. This content will be complemented by a healthy plate and self-care behaviour posters as take-home materials for each participant. The intervention process would take about half-day for each respondent. The intervention programme modules are adapted from “Partner to Improve Diabetes Education”( PRIDE) module and modification will be tailored to the needs of the community and cultural sensitivity.

The expected primary outcome measure changed in glycaemic control and expected secondary outcome measure changed in health literacy, quality of life and physical activity.

The aim of the intervention is to improve the health literacy of Type 2 Diabetes Mellitus patients in a rural community, to enable them to improve better glycaemic control and integrate self-management effectively into their daily lives and also enlightens the policymakers in the formulation of their health policy for T2DM patients, especially in a rural area.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91430 0
Mrs Wan Farzana Fasya Wan Hamdzan
Address 91430 0
Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia,
43400 Serdang, Selangor Darul Ehsan.
MALAYSIA
Country 91430 0
Malaysia
Phone 91430 0
+60176963409
Fax 91430 0
Email 91430 0
farzana_fasya@yahoo.com
Contact person for public queries
Name 91431 0
A/Prof Sazlina Shariff Ghazali
Address 91431 0
Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia,
43400 Serdang, Selangor Darul Ehsan.
MALAYSIA
Country 91431 0
Malaysia
Phone 91431 0
+60397692532
Fax 91431 0
Email 91431 0
sazlina@upm.edu.my
Contact person for scientific queries
Name 91432 0
A/Prof Suriani Ismail
Address 91432 0
Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia,
43400 Serdang, Selangor Darul Ehsan.
MALAYSIA
Country 91432 0
Malaysia
Phone 91432 0
+60389472408
Fax 91432 0
+60389450151
Email 91432 0
si_suriani@upm.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 only
When will data be available (start and end dates)?
Beginning at 2 months and ending by 2 years following main result publications.
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator
PI :- Assoc Prof Dr Suriani Ismail
Email :- si_suriani@upm.edu.my


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4152Informed consent form    377093-(Uploaded-19-08-2019-18-20-12)-Study-related document.pdf



Results publications and other study-related documents

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