The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000890336
Ethics application status
Approved
Date submitted
8/03/2017
Date registered
16/06/2017
Date last updated
16/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cost effectiveness of a health literacy intervention to reduce HbA1c level among type 2 diabetes mellitus patients in Hospital Angkatan Tentera Tuanku Mizan
Scientific title
Cost effectiveness of a health literacy intervention to reduce HbA1c level among type 2 diabetes mellitus patients in Hospital Angkatan Tentera Tuanku Mizan
Secondary ID [1] 291320 0
None
Universal Trial Number (UTN)
U1111-1193-6119
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Melitus 302301 0
Condition category
Condition code
Metabolic and Endocrine 301884 301884 0 0
Diabetes
Public Health 302235 302235 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The educator will be the diabetic nurse.
Intervention module - Diabetes Literacy and Numeracy Education Toolkit (DLNET) adopted and adapted from Vanderbilt University
This module specifically design for diabetes patients with moderate and low health literacy. DLNET used here will be modified to suit the culture, diet and anti diabetic treatment used in Malaysia.
Teaching of this module will be face to face verbally in small groups (6-8 respondents) at a private room in a primary care clinic. Teaching language will be in Bahasa Malaysia. This clinic is run by 2 family medicine physician. The respondents are selected from their diabetic patients list. Each teaching session is 2 hours per session alternate 2 weeks in 2 months (2 session per month in 2 months). The module booklet will be printed in Bahasa Malaysia. It will also available in PDF form. For this research I will be teaching the module with the help of diabetic educator. No treatment will given to the respondents except they will continue with their own medication. The sessions comprise of verbal education explaining self-care entities which are diet, exercise, blood sugar testing and control, medical treatment and foot care.
Teaching technique is based on self-efficacy theory. It will be in two way communication between the educator and respondents.
Other than that whats app group will be created for the intervention group.
Intervention code [1] 297434 0
Behaviour
Intervention code [2] 297907 0
Lifestyle
Intervention code [3] 298128 0
Treatment: Other
Comparator / control treatment
The control group will continue their diabetic education receive from diabetic educator at Army Hospital. The module used is based from Ministry of Health Malaysia. The session will consist of diet, medication and exercise. It will be delivered verbally in Bahasa Malaysia. No booklet will be given and no whats app group will be created.
The teaching session will be held at Medical Clinic in Army Hospital. It will be 2 hours session, 2 weekly in 2 months.
The respondents are selected from their diabetic patients list from the medical clinic.
Control group
Active

Outcomes
Primary outcome [1] 301405 0
Change in HbA1c
Timepoint [1] 301405 0
at baseline data collection and end of intervention (6 months post baseline)
Secondary outcome [1] 332555 0
Diabetes Self-Care Activities Scale Score
Timepoint [1] 332555 0
6 months post randomisation
Secondary outcome [2] 334249 0
Cost effectiveness analysis on providers prospectus from public health service cost records
Timepoint [2] 334249 0
from enrolment to 6 months post enrolment

Eligibility
Key inclusion criteria
i. Inclusion criteria
a. Confirmed patients with Type 2 Diabetes (within 6 months)
b. Adult ( Age = 18-80 years old)
c. Able to understand English or Malay language
d. Low health literacy (Newest Vital Sign score less than 4)
e. Baseline HbA1c is more or equal to 6.5%
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ii. Exclusion criteria
a. Patients who has psychiatric problem (e.g schizophrenia)
b. High health literacy (Newest Vital Sign score more than 3)
c. Corrected visual acuity of less than 20/50 using a Rosenbaum Screener
d. Color blinded

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 enveloped
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 receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The sample size estimation is based on formula of hypothesis testing for two population mean in Adequacy of Sample Size Determination in Health Studies by Lemeshow, Hosmer and Lwanga (1990). Two population mean formula is used due to it being analytical in nature and comparing two groups for hypothesis testing. This is based on patients’ HbA1c level difference pre and post intervention between control and intervention group with response rate of 90%.


Where
N = Sample size estimate
Z1-a/2 = standard error associated with 95% confidence interval = 1.645
Z1-beta = standard error associated with 80% power = 0.842
mu1 = mean of HbA1c post 6 months in intervention group = 9.26% (Butt et al., 2015)
mu2 = mean of HbA1c post 6 months in control group = 8.47% (Butt et al., 2015)
s = estimated standard deviation = 1.5
n = 46.9 ~ 47
N = n x 2 = 94
Adjustment for two groups:
Estimated response rate = 94 / 0.9 = 104
Estimated eligibility = 118.9 / 0.9 = 115
N = 115 participants (for 2 groups) ~ 116
Participants in control group = 58
Participants in intervention group = 58

Statistical analysis:
Statistical analyses will be perform using SPSS from IBM company for Windows version 23. The purpose of these analyses is to answer all the research questions ( Health Literacy Status, HbA1c level, impact of DLNET on reducing HbA1c, self-efficacy score, self-care score, predictors of HbA1c and Cost-effectiveness Analysis).The level of significance for all statistical tests will be set at alpha less than 0.05. Odd numbers will be allocated for the intervention group, so they represent the responses and scores of participants in intervention group, whereas even numbers will be allocated for control group, as they represent the responses and scores of participants in control group.

The researcher will verified the accuracy of data entry with the help of a professional statistician. Both descriptive as well as inferential analyses will be analysed. Outcome variables will be compared at baseline and the effects of intervention on changes in outcome measures will be determined within six month after intervention. Descriptive results will be presented as mean, median, frequency and percentage. Inferential statistics will be utilized where appropriate. Normality assessment statistically and graphically will be assessed. Confidence interval will be set at 95% for the estimation of 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 paired T-test will be used in continuous data.

Data analysis will be done in different stages, with in subject analysis and between subject analyses. A General Linear Model (GLM) will be used for outcome without covariates and with covariates. Multivariate analysis of covariance (MANCOVA) will be used to see the different between controlling the covariates (after post hoc test) and without controlling the covariates (before post hoc test). Spearman correlation will be used to analysis correlation between self-efficacy and self-care. The independent variable of this study is DLNET intervention, intermediate dependent variables are self-efficacy score and self-care score and main dependent variable is HbA1c. The covariates in this study are age, gender, level of education, ethnicity, BMI, comorbidity, duration of diabetes, number of medication and treatment pattern. Cost effectiveness analysis (CEA) will be performed using cost-effectiveness ratio (CER).


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8723 0
Malaysia
State/province [1] 8723 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 295777 0
Self funded/Unfunded
Name [1] 295777 0
Saifulsyahira Jaaman
Address [1] 295777 0
No 49 Jalan Nusaputra 4/1A
Bandar Nusaputra
47130 Puchong
Selangor
Malaysia

Work organisation:
Markas Angkatan Tentera Malaysia
Bahagian Perkhidmatan Kesihatan
Tingkat 11, Menara PTPTN
Megan Avenue II
Jalan Yap Kwan Seng
50450 Kuala Lumpur
Malaysia
Country [1] 295777 0
Malaysia
Primary sponsor type
Individual
Name
Saifulsyahira Jaaman
Address
Department of Community Health
Faculty of Medicine and Health Science
University Putra Malaysia
43400 Serdang
Selangor
Country
Malaysia
Secondary sponsor category [1] 294734 0
None
Name [1] 294734 0
None
Address [1] 294734 0
None
Country [1] 294734 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297075 0
Hospital Angkatan Tentera Tuanku Mizan Ethics Committee
Ethics committee address [1] 297075 0
Jawatankuasa Etika Perubatan
Hospital Angkatan Tentera Tuanku Mizan
No 3 Lot 4/27A Seksyen 2
53300 Wangsa Maju
Kuala Lumpur
Ethics committee country [1] 297075 0
Malaysia
Date submitted for ethics approval [1] 297075 0
31/08/2016
Approval date [1] 297075 0
17/01/2017
Ethics approval number [1] 297075 0
3010587

Summary
Brief summary
Malaysian diabetic patients are mostly poorly controlled, with a mean hemoglobin A1c (HbA1c) of 8.7% and only 22% of patients achieving the treatment goal of <6.5%.Clearly, an improvement in glycemic control is likely to reduce the risk of diabetic complications. Diabetic education is one of the approach to achieve HbA1c target. It is effective for improving clinical outcomes and quality of life of patients with diabetes. Health literacy targeted intervention is one type of diabetic education approach which integrate self-efficacy and self-care behavior into the module. It is targeted towards diabetic patients who have medium to low health literacy. The objective of this study is to develop, implement and evaluate the health literacy targeted intervention on reducing HbA1c level and cost effectiveness of the intervention among Type 2 Diabetes Mellitus patients at Hospital Angkatan Tentera Tuanku Mizan.


This study will be carried out at Hospital Angkatan Tentera Tuanku Mizan (HATTM), specifically at Medical Outpatient Department (MOPD) and primary care centre of HATTM at Kem Kementah. Study design is parallel, single blind, randomized control trial will be used. There will be two arms, there are the intervention arm (receiving the Diabetes Literacy and Numeracy Toolkit (DLNET) module) and control arm (receiving the usual Diabetes Education module). Inclusion criteria will be confirmed patients with T2DM (within 6 months), adult ( Age more than 18 years old), able to understand English or Malay language, low health literacy (NVS score less than 4) and baseline HbA1c higher or equal to 6.5%. Exclusion criteria are patients who has psychiatric problem (e.g schizophrenia), high health literacy (NVS score more than 3), corrected visual acuity of less than 20/50 using a Rosenbaum Screener and color blinded. Sample size estimation is 58 participants for each arm.

Data analysis will be done in different stages, with in subject analysis and between subject analyses. A General Linear Model (GLM) will be used for outcome without covariates and with covariates. Multivariate analysis of covariance (MANCOVA) will be used to see the different between controlling the covariates (after post hoc test) and without controlling the covariates (before post hoc test). Spearman correlation will be used to analysis correlation between self-efficacy and self-care. The independent variable of this study is DLNET intervention, intermediate dependent variables are self-efficacy score and self-care score and main dependent variable is HbA1c. Cost effectiveness analysis will be performed using cost effectiveness ratio
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72886 0
Dr Saifulsyahira Jaaman
Address 72886 0
Department of Community Health
Faculty of Medicine and Health Sciences
Universiti Putra Malaysia
43400 UPM, Serdang
Selangor DarulEhsan
Malaysia
Country 72886 0
Malaysia
Phone 72886 0
+60192287779
Fax 72886 0
Email 72886 0
shirajeri@gmail.com
Contact person for public queries
Name 72887 0
Dr Nor Faiza binti Mohd Tohit
Address 72887 0
Department of Community Health
Faculty of Medicine and Health Sciences
Universiti Putra Malaysia
43400 UPM, Serdang
Selangor DarulEhsan
Malaysia
Country 72887 0
Malaysia
Phone 72887 0
+60172344570
Fax 72887 0
Email 72887 0
faizatohit@outlook.com
Contact person for scientific queries
Name 72888 0
A/Prof Muhammad Hanafiah Juni
Address 72888 0
Department of Community Health
Faculty of Medicine and Health Sciences
Universiti Putra Malaysia
43400 UPM, Serdang
Selangor DarulEhsan
Malaysia
Country 72888 0
Malaysia
Phone 72888 0
+60389472789
Fax 72888 0
+60389450151
Email 72888 0
hanafiah_juni@upm.edu.my

No information has been provided regarding IPD availability
Summary results
No Results