None listed
Conditions
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.
Interventions
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 fo
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.
Sponsors
Fundamental Research Grant Scheme (FRGS), Ministry of Higher Education Malaysia (MoHE)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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
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
Outcome results
None listed