Existing knowledge:

Individuals with type-2 diabetes are at a high risk of developing a range of debilitating complications such as cardiovascular disease, peripheral vascular disease, nephropathy, changes to the retina and blindness that can lead to disability and premature death. It also imposes important medical and economic burdens (Asif 2014).

1. What do you know about these topics in relation to DM – dietary changes &exercise regime Why are they impt?
2. Diabetes education significantly improved the percentage of patients achieving therapeutic targets and increased medication adherence and self-care performance (Fan et al., 2016)
3. Diabetic education was also associated with a lower rate of chronic complications from chronic illness (Fan et al., 2016).

Gap:

Most current diabetes education programs are knowledge-based and have emphasis on lifestyle changes, self-care and active participation in disease management.These education sessions were often delivered to a group of patients.

There is little information about the effect of individualized and personality specific diabetes education on (these areas – dietary changes & exercise regime) the management outcomes of T2DM

Why study will help:

Good glycaemic control inpatient does not promised good glycaemic control at home. Therefore, it is essential to assist people with diabetes in obtaining the knowledge, skills, and abilities (changing –these area – dietary changes, lifestyle changes and medication compliant) required for effective, sustained self-management of their condition at home.

Design

Experimental (RCT)

Sampling and recruitment

Sample size: 100 control group & 100 experimental group

There will be 4 arm

• 50 in control group with caregiver
• 50 in control group without caregiver
• 50 in experimental group with caregiver
• 50 in experimental group without caregiver

Inclusion criteria

a) Established diagnosis of T2DM
b) HbA1C above 7
c) Able to participate follow-up studies and involvement in activity carry out by research committee for study purposes
d) pt that comply to medication regime
e) Pt and caregiver that can understand English or Chinese

Exclusion criteria:

a) Severe co-morbidities, such as renal failure, hepatic dysfunction, cancer or stroke
b) Uncontrolled complications from diabetes, such as acidosis, infection, peripheral vascular disease resulting amputation or leg ulcer.

Process of recruitment of subject:

(1) Gather names of patients with HbA1c above 7 from 20 community nurses in Northview Hospital.
(2) Once identified, community nurse to arrange a home visit with one of the research nurse.
(3) Research nurse will bring a consent form in subject preferred language.

• consent form would be available in English, Mandarin, Malay, and Tamil language.
• If subject is illiterate, subject can approach other trustable party for verification.

(4) Research purpose will be explain

• includes duration of research, needs for repeat blood checking and blood glucose monitoring at home, benefits that subject will possibly gain from the process and the discomfort from blood taking and sugar monitoring.

(5) If subject agreeable, to sign consent form.

Primary outcome: HbA1C

Secondary outcome:

What would you measure for dietary changes, exercise and medication compliant?

Intervention: (needs evidence how the following is formulated)

Intervention

Exercise – session
Dietary – choice of food – dietitian;

(1) experimental group – participants to draft out a diet plan (template) – endorsed by dietitian – empower individual in self-management_+ exercise regime
(2) control / existing practice – given education + their usual exercise routine

Strata/randomization ….

How to empower their knowledge

conduct workshop for all subject from experimental group. All sessions are expected to be interactive and promote 2 ways communication.

1) workshop by nurse on diabetes mellitus(both CG and EG will undergo this workshop)
2) workshop by dietitian on healthy cooking and choice of food (EG only)
3) exercise session by exercise trainer (EG only)
4) peer teaching to encourage reinforcement and understanding towards DM knowledge includes lifestyle and dietary modification (EG only)
5) include the cooking session (lunch) with healthy cooking tips learned. (EG)
6) conduct individual consultation session to work out individualised plan for each subject. (eg ONLY)

Strategy for data collection

Interview understand subject dietary intake & exercise regime

• prepare necessary data collection tool (blood glucose monitoring requisite, blood glucose chart)
• conduct a teaching session on blood glucose monitoring using blood glucose machine
  Won’t give template of programme
• Initial blood taking – Baseline HbA1cfor all subject.

This is for the experimental arm?

• Interview to understand subject dietary intake, lifestyle habit and medication compliant.
• prepare necessary data collection tool (blood glucose monitoring requisite, blood glucose chart)
• conduct a teaching session on blood glucose monitoring using blood glucose machine
• a template of programmes and follow up will be brief (12 weeks activity template to guide subject)
• Data will be collected for 12 week