Effectiveness of Pharmacy Integrated Community Care (PICC) Improving Hemoglobin A1c (HBA1C) and Knowledge in Diabetes Mellitus (DM) Education Program
Phase: NA
Conditions: Diabetes Mellitus, Type2 Diabetes
Sponsor: Clinical Research Centre, Malaysia

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Study Protocol 
 
 
Effectiveness of Pharmacy Integrated Community Care (PICC) improving 
Hemoglobin A1c (HBA1C) and Knowledge in diabetes mellitus (DM) education 
program  
 
Protocol number, version number and date:  
NCT05106231/ PICC0006, Version 6.0 dated 16 June 2023 
 
Ethical Approval received on 9 July 2021 from Medical Reasearch & Ethics 
Committee, Ministry of Health Malaysia. 
Approval number: NMRR-21-767-59240 
 
 
 
 
 
 

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Study Protocol 
 
Effectiveness of Pharmacy Integrated Community Care (PICC) improving 
Hemoglobin A1c (HBA1C) and Knowledge in diabetes mellitus (DM) education 
program  
 
Protocol number, version number and date:  
PICC0007, Version 7.0 dated 14 February 2024 
 
Name and Institution of Principal investigator: 
  Kamarudin Bin Ahmad, Hospital Miri 
Dr Lawrence Anchah, Medical Faculty UNIMAS 
 
Name and Institution of Co-Investigators: 
Name 
Working Institution 
Study Site 
District 
Kamarudin Bin 
Ahmad 
Hospital Miri 
Klinik Kesihatan 
Bandar Miri 
Miri 
Dr Lawrence 
Anchah 
Medical Faculty 
UNIMAS 
Klinik Kesihatan 
Jalan Masjid 
Kuching 
Kuching 
Lim Su Ee 
Bahagian 
Perkhidmatan 
Farmasi, Jabatan 
Kesihatan Negeri 
Sarawak 
Klinik Kesihatan 
Jalan Masjid 
Kuching 
Kuching 
Izzul Syazwan Bin 
Syuib 
Cawangan 
Penguatkuasa 
Farmasi, Jabatan 
Kesihatan Negeri 
Sarawak 
Klinik Kesihatan 
Jalan Masjid 
Kuching 
Kuching 
 
Amy Ting Siew Shin 
Pejabat Kesihatan 
Bahagian Sarikei 
Klinik Kesihatan 
Sarikei 
Sarikei 
Chai Min Choo 
Klinik Kesihatan 
Tudan 
Klinik Kesihatan 
Bandar Miri 
Miri 
Chang Poh Yin 
Klinik Kesihatan Jalan 
Oya 
Klinik Kesihatan 
Jalan Oya 
Sibu 
Juliet Lau Lu Lin 
Klinik Kesihatan  
Jalan Masjid 
Klinik Kesihatan 
Jalan Masjid 
Kuching 
Kuching 
Kenny Goh Wei 
Chuan 
Klinik Kesihatan 
Siburan 
Klinik Kesihatan 
Siburan 
Serian 
Kho Boon Yan 
Klinik Kesihatan Daro 
Klinik Kesihatan 
Daro 
Mukah 

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Kiu Kuan Chia 
Klinik Kesihatan Pusa Klinik Kesihatan 
Pusa 
Betong 
Mary Wong Siew 
King 
Klinik Kesihatan Sri 
Aman 
Klinik Kesihatan Sri 
Aman 
Sri Aman 
Ngu Chiew Pin 
Klinik Kesihatan Kapit Klinik Kesihatan 
Kapit 
Kapit 
 
Name and address of Sponsor: 
Using departmental operating budget, Jabatan Kesihatan Negeri Sarawak, 
Kementerian Kesihatan Malaysia 
 
Study site/s: 
 
Klinik Kesihatan Bandar Miri 
Klinik Kesihatan Jalan Masjid Kuching 
Klinik Kesihatan Sarikei 
Klinik Kesihatan Jalan Oya 
Klinik Kesihatan Siburan 
Klinik Kesihatan Daro 
Klinik Kesihatan Pusa 
Klinik Kesihatan Sri Aman 
  Klinik Kesihatan Kapit 
 
 
 
 
 
 
 
 
 
 
 

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Contents 
Topic 
Page 
List of Abbreviations 
4 
Research Synopsis 
5 
Background and Significance 
6 
Literature Review 
11 
Research Questions 
16 
General Objective 
18 
Specific Objectives 
19 
Study Design and Methodology 
 
   Part I:  Systematic Review 
20 
     Search Strategy 
20 
     Selection Criteria 
20 
     Data Extraction and Analysis 
20 
   Part II: PICC Trials 
21 
     Study Population 
21 
Sample Size 
21 
Inclusion Criteria 
22 
Exclusion Criteria 
23 
Recruitment 
24 
Withdrawal Criteria 
24 
Randomisation and Blinding 
26 
Intervention design/Study Visits and Procedures 
27 
Study Duration and Timeline 
44 
Study Endpoints/Outcomes 
50 
Statistical Analysis Plan 
50 
Ethics of Study 
50 
Informed Consent/Assent Process 
51 
Risk to Participants 
51 
Benefits to Participants 
51 
Risk-Benefit Assessment 
51 
Privacy and Confidentiality 
52 
Conflict of Interest 
53 
Publication Policy 
53 
Termination of Study 
53 
   Part III: Qualitative Survey 
54 
Study Design 
54 
Analysis Plan 
56 
Gantt Chart 
59 
Expected Cost 
60 
References 
62 
Appendix 1 
66 
Appendix 2 
67 
 

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List of Abbreviations 
AKYM 
Ambassadors Know Your Medicine (AKYM) 
CONSORT 
Consolidated Standards of Reporting Trials 
DM 
diabetes mellitus 
DMTAC 
diabetes medication therapy adherence clinic (DMTAC) 
GBI 
group-based intervention (GBI) 
HBA1C 
Hemoglobin A1c  
IMP 
investigation of the medicinal product  
MREC 
Medical Research and Ethics Committee  
NCDs 
non-communicable diseases  
NHMS 
National Health Morbidity Survey 
NPAN 
National Plan of Action for Nutrition (NPAN III) 
PhIS 
Pharmacy Information System  
PICC 
Pharmacy Integrated Community Care 
SAE 
serious adverse event  
SGBI 
Structured group-based intervention 
SPIRIT 
Standard Protocol Items: Recommendations for Interventional 
SUSAR 
serious adverse reaction  
T2DM 
Type 2 diabetes mellitus 
WHO 
World Health Organization 
 
 
 
 
 
 
 
 
 
 
 
 

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Research Synopsis 
Study title 
Effectiveness of Pharmacy Integrated Community Care (PICC) 
improving Hemoglobin A1c (HBA1C) and Knowledge in 
diabetes mellitus (DM) education program  
Study Population 
The study population will be local people living in Sarawak from 
multiple racial backgrounds with underlying type 2 diabetes 
mellitus (T2DM).  We recruit patients with underlying T2DM 
mellitus who obtain medication at the primary Government 
Health Clinic in each district. 
Study Design 
The study's design will be a prospective, multicenter and 
parallel-design single blind randomised controlled with two 
treatment groups. The trial evaluates a PICC's effectiveness in 
improving HBA1C involving four-session structured group-
based intervention (SGBI) of a two to three-hour pharmacist-led 
program with follow up evaluations. The control arm is Diabetes 
Medication Adherence Clinic (DMTAC). 
General Objective 
1. To describe and critically appraised DM education studies. 
2. To examine the program's effectiveness versus control in 
improving medication adherence with underlying T2DM in 
the Sarawak State of Malaysia. 
Specific Objectives 
1. To measure the effectiveness of PICC in improving 
HbA1C, fasting blood glucose and understanding  
2. To investigate the sustainability of the program. 
Study 
endpoints/outcomes 
Primary outcome: laboratory-analysed HbA1C will be the 
primary outcome.  
Secondary 
outcome: 
Investigating 
knowledge 
and 
understanding of DM medication management will be 
evaluated using the quizzes in the PICC program. 
Sample Size 
A previous study has shown a standard deviation of 1.5.  
Suppose the true difference between the experimental and 
control means is 1, 36 experimental subjects and 36 control 
subjects with a probability (power) of 0.8.  By estimating 30% 
dropout or incomplete data, a minimum sample size of 94 (47 
for each group). 
Study Duration 
1 May 2023 to 31 August 2023. 
 
 
 

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RESEARCH PROPOSAL FOR HIGHER DEGREE PROGRAMMES 
BY: KAMARUDIN BIN AHMAD  
 
 
1. 
Field of Research 
 
Clinical Trials 
 
2. 
Topic of Research 
 
Effectiveness of Pharmacy Integrated Community Care (PICC) improving 
Hemoglobin A1c (HBA1C) and Knowledge in diabetes mellitus (DM) 
education program  
 
3. 
Background and Significance 
 
3.1 
Current situation globally on DM 
What happens globally on DM? How does it affect people? 
 
According to WHO global statistics on diabetes mellitus (DM), the prevalence 
among adults 18 years of age has risen from 4.7% in 1980 to 8.5% in 2014.1 It is 
also worrying that the majority of DM has been growing more rapidly in the middle- 
and low-middle and low-income countries such as in Malaysia (1).  
 
T2DM continues to increase in prevalence, incidence and is a leading cause of 
human suffering and death. Despite significant investments in clinical care, 
research, and public health interventions, there appears to be no sign of a 
reduction in the rate of increase. Certain regions of the world, such as Western 
Europe and island states in the Pacific, are experiencing a disproportionately high 
burden (2).  
 

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WHO estimates that the number of people with diabetes in the Western Pacific 
Region may reach 150 million by 2025 appear by no means unrealistic and may 
even be conservative (3). Globally, about 1 in 11 adults have DM (90% have 
T2DM), and Asia is the epicentre of this global T2DM epidemic (4).  
 
Given its global influence, it is essential to break the vicious cycle of DM by getting 
DM over generations by implementing effective strategies to prevent gestational 
DM. Among patients with T2DM, cardiovascular complications are the leading 
cause of morbidity and mortality, and kidney complications are highly prevalent in 
patients in Asia with DM (4-6).  
 
Poor medication adherence is a public health problem that incurs a considerable 
financial cost (7). Poor adherence may reduce the effectiveness of treatment. A 
recent systematic review found that nonadherence to oral antidiabetic medication 
ranged from 36% to 93% in patients remaining on treatment for at least six months 
(8). 
 
The burden of T2DM and its complications is substantial and escalating and poses 
a substantial economic burden. Significant challenges include unawareness, 
undiagnosed cases, the coexistence of T2DM with tuberculosis and other 
infections, the high costof diagnostic tests, insulin, and drugs, and the scarcity of 
trained health workers (9). 
 
What causes it increase in DM prevalance? 
 
The major driving factors of the global T2DM epidemic include overweight and 
obesity, sedentary lifestyle and increased consumption of unhealthy diets 
containing high levels of red meat and processed meat, refined grains and sugar-
sweetened beverages (4). The appearance of T2DM, in association with obesity, 
in children is a cause for particular concern. The easy availability of fast foods and 
a sedentary lifestyle, associated with lack of physical play, television and 

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computers, and mechanisation, have rapidly altered the behaviour patterns of the 
urbanised young in many of Asia’s megacities (3). 
 
The overall empirical evidence suggested that higher socio‐economic status, more 
excellent dietary knowledge, and higher self‐efficacy and empowerment improve 
glycaemic control among patients with diabetes. Higher socio‐economic statuses 
and good diabetes‐related knowledge were more likely to have better glycaemic 
control due to more accessible access to resources and better compliance to 
diabetes self‐management (10). 
 
What should we do to fight DM? 
 
This epidemic will require an urgent and unwavering commitment to aggressive 
solutions at national levels with public policies, public health funding, and economic 
incentives for local communities to start diabetes prevention programs. Healthy 
eating options need to be subsidized, and unhealthy foods need to be taxed or 
otherwise disincentivised. Healthcare organisations and individual healthcare 
providers from multiple disciplines (doctors, nurses, pharmacists, dieticians, and 
diabetes educators) must be given time and resources to collaborate as they 
educate and care for individuals and groups of patients. Unless urgent measures 
are instituted to reduce unhealthy eating, sedentary lifestyles, rapid urbanisation, 
and other factors related to economic development, the burden of diabetes is 
expected to continue rising (2). 
 
Efforts to contain this epidemic should include increasing awareness, effective 
primary prevention, the use of allied health professionals for prevention and 
education, improving the standard of care, using mobile phones and telemedicine 
to deliver health messages, and regulation to promote healthy foods and curb 
unhealthy oils and sugary drinks (9) 
 

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In addition, with higher self‐efficacy and empowerment, patients with DM are more 
motivated to use a dynamic approach to acquire dietary knowledge and actively 
seeking health‐promoting behaviours to enhance diabetes self‐management. 
Further research must be conducted to comprehend the drivers of this epidemic to 
improve prevention strategies for this public health issue. In addition, greater 
emphasis needs to be placed on implementing lifestyle changes on a societal level 
to stem the tide of the epidemic. It is necessary to implementation accessible 
multicultural educational initiatives for the general public (10). 
 
3.3 
Strategy reducing DM  
Major clinical trials have demonstrated that diet and lifestyle modifications are 
effective in preventing T2DM in high-risk individuals. T2DM management 
strategies, including lifestyle modifications, social support and ensuring medication 
adherence, are vital in reducing DM complications (4, 9, 11, 12). 
 
Higher socio‐economic status, more excellent dietary knowledge, and higher self‐
efficacy and empowerment are also shown to improve glycaemic control among 
patients with DM (10). Future public health policy must be geared towards 
increasing the capability of dealing with the rising incidence of diabetes and 
implementing primary prevention. There is a need to prevent lifestyle‐related 
diseases by emphasising patient empowerment (10). 
 
Having a good or poor knowledge level on diabetes medication does not guarantee 
their health-seeking practice of medication adherence. Therefore, further focus on 
providing patient education and support in health care clinics to ensure that they 
have sufficient awareness of diabetes and the practice of medication adherence in 
order to prevent the early development of diabetes complications (13). 
 
Lay-led, group-based self-management interventions were revealed to have 
significant effects on improvement of HbA1c levels, self-efficacy, reduce costs, 
reduce complications, and improve the quality of life for patients (14, 15). Hence, 

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an intervention could motivate them intrinsically toward self-management 
behaviours to manage their conditions better and for a more extended sustained 
period. Such interventions were also shown to improve their confidence to manage 
their condition and reduce its complications, to benefit them clinically.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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3.4 
Literature Review 
 
The current situation in Malaysia 
 
 
In the 2011 National Health and Morbidity Survey (NHMS) IV, of those already 
diagnosed with diabetes, an estimated 1.1 million received treatment at public 
health care facilities (16). Of those receiving public-based health care, an 
estimated 70% attended primary care clinics, whereas the remaining received 
treatment and follow-up at public hospitals (16). The prevalence of DM rose in 
2015 to 17.5% (9).   
 
Overall, we estimated the total cost of diabetes as RM2.04 billion per year for the 
year 2011 (both public and private sector). Of this, RM1.40 billion per year was 
incurred by the government. Despite some limitations, we believe our study 
provides insight into the actual cost of diabetes to the country. The high cost to the 
nation highlights the importance of primary and secondary prevention (17). 
 
.Medical officers and physicians mainly deliver public hospital-based diabetes care 
comprehensively within general medicine outpatient clinics. Consultations are 
focused on optimising glycemic control with antihyperglycemic therapies (alone or 
in combination) and reinforcing lifestyle intervention while specifically addressing 
cardiovascular risk reduction (18). Multidisciplinary care is available in tertiary and 
primary care settings to integrate pharmacotherapy, diet, and lifestyle changes 
(19).  
 
The Malaysians had a moderate medication adherence level, whereas they were 
nonadherent to blood glucose testing (20). Emphasis on self-care activities and 
medication adherence is relevant to improving type-2 DM (T2DM). Results of this 
study indicated that low medication adherence was related to a larger BMI and a 
poorer HbA1c. Patients had the highest mean score for general diet on the 
SDSCA. It was also revealed that the patients had better self-care behaviour in the 

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general diet than blood glucose testing. Primary health care providers should 
provide adequate counselling for adults with T2DM (20) 
 
A study in Malaysia described how patients are informed and influenced by several 
sources: family members, friends and peers, health care providers, books and 
electronic materials (21). Studies have indicated that lower education is associated 
with more inadequate diabetes knowledge (22, 23). However, diabetes 
empowerment scores were high among T2DM patients who had above secondary 
education level, diabetes education exposure, no ischemic heart disease status 
and lower HbA1c; thus, all the diabetes patients should be educated and empower 
on self-care for long-term diabetes management (24). 
 
Strategies reducing DM in Malaysia 
Various action plans and programs have already been formulated and 
implemented in the country. Reducing non-communicable diseases (NCDs) 
(including diabetes) is one of the three objectives of the third edition of the National 
Plan of Action for Nutrition (NPAN III) of Malaysia (2016–2025)(25) and The 
National Strategic Plan for Non-Communicable Disease (2010–2014) is a medium-
term strategic plan to strengthen further the cardiovascular diseases and diabetes 
prevention and control program in Malaysia (26).   
 
Despite the various action plans outlined above, adherence plays an essential 
factor in DM medication therapy. A recent national survey in Malaysia revealed 
that 73.1% of Malaysians did not adhere to the medications that they are 
prescribed (27). The only local literature supporting the positive association 
between patient satisfaction and medication adherence in T2DM patients was a 
study amongst patients attending the diabetes medication therapy adherence 
clinic (DMTAC) run by pharmacists (28). DMTAC is a structured DM education 
program to help the patient to cope with various need-to-know information on DM 

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so that they can do self-care. The patients were satisfied with the DMTAC service; 
however, the majority of the patients not adhered to their medications (29).  
 
In order to increase health literacy and self-care practices, the Know Your Medicine 
Campaign was launch to create awareness for Malaysians (27). A survey was 
conducted; however, approximately half of the respondents were not aware of the 
KYM campaign with the urban population was found more knowledgeable about 
the appropriate use of medicines (27). Efforts to disseminate the information, 
especially among the rural population, should be strengthened through adopting 
the most accessible media channels (30). 
 
A recent trial on ‘Know Your Medicine – Take it for Health’ (MEDIHEALTH) in 
Malaysia tested the effectiveness of structure group-based intervention (SGBI) 
(31). The targeted well-structured DM education under that program proved an 
increase in medication adherence, specifically in DM (32). Thus, DM education 
might be the key to the success of DM control. Both pharmacist-led and physician-
led interventions in improving medication adherence were found to be effective. 
Hence, it is suggested that a multifaceted approach with the involvement of 
different healthcare professionals should be encouraged to synergise the 
strengths of each profession and further enhance the effectiveness of interventions 
(33). 
Soon after MEDIHEALTH, the Ministry of Health Malaysia endorses Pharmacy 
Integrated Community Care (PICC) which is an innovation introduced by the 
Pharmaceutical Services Division, Terengganu State Health Department. The 
programme aims to optimise the treatment of patients' diabetes in the community. 
In 2020, this initiative improved and expanded nationwide to enable people to 
benefit from this initiative. PICC includes medication management activities, 
healthy lifestyle practices and a balanced diet. PICC implemented through 
pharmacy officers' collaboration; Ambassadors Know Your Medicine (AKYM), 
dietetic officers, nutrition science officers, nurses, assistant medical officers and 

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physiotherapists. AKYM came from an activist that promotes the Know Your 
Medicine Campaign. 
PICC creating support groups for DM patients that help increase motivation in 
controlling diabetes, recognising and understanding diabetes, self-management 
and provide exposure to nutrition and a healthy lifestyle to people with diabetes.  
PICC participants consist of diabetics in the community.  A pharmacist or AKYM 
will select the participant for this program. Participants must agree to attend at 
least three of the four PICC sessions. Patients with uncontrolled mental illness 
excluded from the program. 
 
How GBI improved DM in Malaysia and other countries? 
Zare et al. (2020) conduct a systematic review of a self-care intervention study to 
assess the effectiveness of diabetic self-management and the appropriateness of 
the used theories and models. Interventions that utilise self-efficacy, social 
support, or empowerment constructs in addition to intra-individual constructs have 
been shown more effective which delivered by using GBI (15).  
GBI was revealed to significantly affect HbA1c levels, self-efficacy, and frequency 
of emergency visits (14). Consistent with trials on GBI in Malaysia (32, 34, 35), 
various studies show an intervention could motivate them intrinsically toward self-
management, improved negative emotions and health-coping behaviours (36-38). 
Such interventions were also shown to improve their confidence to manage their 
condition and reduce its complications, to benefit them clinically.  
Few studies have been done regarding the effects of GBI on the frequency of 
emergency visits. Reductions in emergency visits can also reduce the health care 
cost, which can reduce the overall rising cost related to treating complications 
related to T2DM (14). 
 

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What are the gaps in GBI studies? 
Trials on GBI in Malaysia focus on medication adherence and self-care practices 
(32, 34, 35). Other studies of diabetes in Malaysia have suggested that patients 
have inadequate knowledge of diabetes and a shortage of professional educators 
such as dieticians or diabetes educators (22, 35, 39). One study reported some 
challenges that diabetes educators face in effectively helping patients with their 
self-care. Given limited resources, creative approaches such as brief, structured 
education may help address knowledge gaps and improve diabetes self-care (35). 
 
Healthcare professionals can assist patients in setting diabetes-related health 
goals that are clinically appropriate and acceptable to the patient. By considering 
the desire for more knowledge, health professionals provide patients with specific, 
practical counselling on diet, exercise, and medications. Existing resource 
limitations within the healthcare system, such as inadequate access to dieticians, 
necessitate creative solutions. While keeping in mind common diabetes self-care 
barriers and facilitators, health professionals also recognise that these may vary 
across and within ethnic groups. Healthcare providers can understand the barriers 
and facilitators most relevant to a specific patient (40). 
There is a gap in the practice of diabetes educators and the need for change in the 
approach to service delivery and the healthcare organisation as a whole. 
Conducting action research or participatory research would help implement 
patient-centred care intervention, as it would empower the stakeholders, facilitate 
their interest and participation and simultaneously increase their sense of 
responsibility and ownership of the intervention (41). This would also reduce the 
possibility of resistance to implementing changes in the healthcare system (42).  
 
Education is a prerequisite for effective diabetes management and will remain a 
fundamental part of treating the disease for the foreseeable future; therefore, for 
both ethical and practical reasons, it remains of great importance to providing 
everyone with diabetes education that is culturally and socially appropriate for their 

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situation (36). However, there were many variations in design regarding the 
delivery of diabetes education by peer leaders and the way support was given. GBI 
should follow a set of evidence-based guidelines to enable the standardisation of 
interventions and allow its effects to be transferable across cultural barriers (14). 
PICC could serve a  function in an effort towards standardisation; however, 
improving the knowledge in DM patients is yet to be proven. 
 
3.4 
Research Questions 
How effective is PICC? 
 
Malaysia has developed various action plans to curb DM  that consist of nutrition, 
obesity and non-communicable disease. Despite the various action plans,  it would 
be essential to ask why the prevalence of diabetes and risk factors remains at high 
levels (43). It is essential to scrutinise the implementation of these plans and 
identify the reasons for the shortfalls and the challenges faced. The main 
challenges identified in this review included a lack of intersectoral and multi-
stakeholder coordination, lack of human resource capacity to deliver the identified 
programs and lack of monitoring and evaluation. These shortcomings require 
transformation when implementing the next phase of national plans. This study will 
evaluate the effectiveness of PICC as one of the national initiatives to curb DM.  
 
The PICC trial will explore the program's effectiveness and find gaps to improve 
patient knowledge in DM, self-care practices and glycaemic control. Conducting 
PICC trials would help implement patient-centred care intervention, which would 
empower the stakeholders, facilitate their interest and participation and 
simultaneously increase their sense of responsibility and ownership of the 
intervention. Hence, this would also reduce the possibility of resistance to 
implementing changes in the healthcare system. 
 
 

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How effective PICC improve DM knowledge? 
 
Studies found limited knowledge to be prevalent in patients with T2DM, which 
means that most patients cannot use their abilities to find fully understand, reflect 
and apply information to optimally manage their disease (44, 45). We need 
strategies to improve DM knowledge. Given limited resources, creative 
approaches such as PICC may help address knowledge gaps and improve 
diabetes self-care.  
 
Is there a strong association between DM Knowledge and HbA1C? 
 
Management self-efficacy and other patient characteristics found no evidence to 
suggest diabetes knowledge is associated with blood glucose control, a result 
consistent with that found by Coates (46). However, this lack of association is 
inconsistent with several studies considering the impact of diabetes knowledge on 
glycaemic control. For example, others have demonstrated that higher knowledge 
is associated with higher control in other populations (47-49), whereas McPherson 
et al. (2008) showed (50) that diabetes knowledge was inversely associated with 
glycemic control (51); thus, the discrepancies require further investigation. 
 
 
 
 
 
 
 
 
 
 
 
 

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Theoretical Framework 
 
 
 
 
 
 
 
 
 
Figure 1: Conceptual framework of the PICC trial. 
 
Hypotheses based on the conceptual framework: 
 
H1:  
There is a significant difference in medication adherence to diabetes 
medication between the PICC and control groups. 
H2: 
There is a significant difference in the reduction of HbA1C between the 
PICC group and the control group with higher medication adherence 
H3:  
There is a significant difference in knowledge of diabetes medication 
between the PICC group and the control group. 
H4: 
There is a significant difference in the reduction of HbA1C between the 
PICC group and the control group with a higher understanding and 
knowledge of diabetes 
 
3.5 
General Objectives 
 
 
(a) 
Systematic review on DM knowledge study in Malaysia 
Many approaches improving diabetic knowledge and HbA1C; however, there is no 
answer to which is the best or goal standard in Malaysia. A systematic review helps 
H1 
H2
Adhere to 
medication 
Reduction in HbA1C 
PICC 
Understanding 
and 
Knowledge on 
diabetes 
H3 
H4 

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uncover the gaps and highlights the most feasible and practical technique for a 
non-pharmacological approach in DM therapy. 
(b)  
Trials on PICC program 
 Recent trials concluded that GBI employing self-management education for T2DM 
patients improves medication adherence and glycaemic control among Malay 
T2DM patients. These effects were mediated by an improvement in knowledge 
about medications and perceived behavioural control on medication adherence. 
However, intervention is a culturally sensitive intervention designed for Malay 
T2DM in Sarawak (31).   
Hence, the present study aimed to bridge the gap in the literature by examining 
the effectiveness of PICC on improving HbA1C, fasting blood glucose and 
understanding of the program to the multiracial in Sarawak. 
(c)  
Qualitative survey on the PICC program 
PICC is a DM teaching program that gives awareness to the participants and also 
helps them to incorporate appropriate lifestyles and habits in the long run. This 
initiative implements the Ministry of Health Malaysia; however, no studies available 
to evaluate the effectiveness and explore participants perceptions towards the 
program. 
4. 
Specific objectives 
The first part will deal with a systematic review of diabetic education in Malaysia. 
The aim will be to describe and critically appraised DM education studies. 
The second part will deal with a trial on the PICC program among DM patients in 
Sarawak. The aim will be to examine the program's effectiveness versus control in 
improving medication adherence with underlying T2DM in the Sarawak State of 
Malaysia. The specific objectives of this study are: 
a) to measure the effectiveness of PICC in improving HbA1C, fasting blood 
glucose and understanding  

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b) to investigate the sustainability of the program.  
The third part will explore the satisfaction of joining the PICC program using a 
qualitative survey approach. The aim is to dive into the issues on context, 
implementation, mechanism and effectiveness.  
5. 
Methods 
 
Part 1: A Systematic Review on DM education in Malaysia 
 
5.1 
Search Strategy 
Metasearch of online literature will be conducted on electronic databases such as 
Pubmed, MEDLINE, EMBASE and other specialised journals (e.g. Journal of 
Diabetes and its Complications, International Journal of Diabetes and Clinical 
Research, and Journal of Diabetes). Unpublished trials will be identified by 
contacting the researchers.  
 
5.2  
Selection Criteria 
All observational studies on the DM education program in Malaysia will be 
considered for inclusion.    
 
5.3 
Data Extraction and Analysis 
 
All relevant data will be extracted using a standardised form. I will independently 
extract the data from the selected studies, and my supervisor will cross-validate at 
random the data extracted. The following data will be extracted: study 
identification, types of study, DM education approach, description of the subject, 
findings and conclusions.   
 
Part II: PICC Trials 

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Study Visits and Procedures 
 
Study Design 
The study's design will be a prospective, multicenter, and sequential-design 
randomized controlled trial with two treatment groups. The protocol follows the 
Standard Protocol Items from Recommendations for Interventional Trials (SPIRIT) 
checklist. The trial aims to evaluate the effectiveness of a PICC in improving HbA1c 
levels.  
Participants will be enrolled sequentially based on their arrival at the study sites 
and their eligibility for inclusion criteria. Sequential allocation will be carried out 
using a predetermined randomization sequence generated by a the Sarawak 
Pharmacy Service Division. The allocation sequence will be concealed until the 
participants are assigned to their respective treatment groups.  
The trial evaluates a PICC's effectiveness in improving HBA1C that involves four 
sessions of GBI of a two to three hours pharmacist-led program with follow-up 
evaluations, while the control arm will receive standard treatment from Diabetes 
Medication Therapy Adherence Clinic (DMTAC). The trial period will be from 1st 
May to 31st August 2023. 
Study Population and Setting 
The study population will be local people living in Sarawak from multiple racial 
backgrounds with underlying T2DM.  We recruit patients with underlying T2DM 
who obtain medication at the primary Government Health Clinic in each district and 
randomly assigned them to the treatment group PICC or the control group. The 
primary outcome of this study is HbA1C levels. The secondary outcomes are 
knowledge of the PICC Program. 
 

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Sample size 
This study involved a continuous response variable from control and experimental 
subjects with one control per experimental subject. In a previous study (31), each 
subject group's response was normally distributed with a standard deviation of 1.5. 
If the true difference between the experimental and control means is 1, 36 
experimental subjects and 36 control subjects would be required to reject the null 
hypothesis that the population means of the experimental and control groups are 
equal, with a probability (power) of 0.8.  By estimating 30% dropout or incomplete 
data, a minimum sample size of 94 (47 for each group) was pre-determined, as 
shown in Figure 2. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 2. Trial Flow accordance to Consolidated Standards of Reporting Trials 
(CONSORT) 
 
 
 
Screening for eligible respondent (n=?) 
Excluded (n=?) 
Reason(s) 
Randomization 
Consent Obtained (n=?) 
Intervention group (n=47) 
Control group (n=47) 
Control group (n=?) 
Intervention group (n=?) 
Intervention 
Post 4 month 
intervention 

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Inclusion Criteria  
 
A computer-generated list of participants will be allocated to the control and 
intervention groups (explained further in the randomisation section), as shown in 
Figure 2. The participants were recruited during their routine clinic visits at a 
government clinic that provides primary care in each division of Sarawak. 
Participants with T2DM were included if they: 
1. were non-pregnant adults >18 years of age regardless of gender or ethnicity; 
2. spoke and understood Bahasa Malaysia   
3. had a medical record showing haemoglobin A1c test (HbA1c) level of ≥6.3% (45 
mmol/mol) and fasting plasma glucose test (FPG) ≥7.0 mmol/L 
4.  Patients also need to be able to provide informed consent to participate in the 
study 
 
Exclusion Criteria  
 
Participants were excluded if they could not answer the quizzes independently or 
had a hearing or vision impairment. Patients unable to read, write and speak 
Malay, medically unstable or unable to provide informed consent will be excluded. 
Patients who are currently attending intensive psychological treatment, 
hospitalised and participating in other studies will also be excluded from the study. 
 
 
Extraneous Variable/ Confounding Variables 
Several extraneous variables would affect the outcome of this study based on the 
literature. A review classified the contributing factors of adhering to diabetic 
medications into five dimensions, namely (1) patient-related, (2) condition-related, 
(3) socioeconomic, (4) health system-related and (5) therapy-related (52). 
Furthermore, a more recent review (53) on the factors associated with diabetes 

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medication adherence are categorized into (1) patient factors, (2) prescription 
factors and (3) prescriber factors. 
Hence, extraneous variables included in this study will be (1) route of 
administration, oral only or oral and insulin injection; (2) numbers of medications, 
one or more than one (54); (3) frequency of the medications, a once-daily dose or 
more frequent (55); (4) age; (5) gender; (6) highest education level; (7) monthly 
household income; (8) employment status; (9) having complications; (10) taking 
traditional complementary and alternative medicines; (11) residential area, urban 
or rural; (12) living condition, having social support or stay individually; (13) 
undergone diabetic education by the diabetic nurse; (14) enrolled with diabetic 
MTAC. 
 
Recruitment  
In this study, we recruited prospective and eligible respondents consecutively from 
primary health clinics located in nine divisions. We approached them during their 
routine visits before intervention between 1st May and 31st May 2023. Potential 
subjects were introduced to the PICC concept and invited to participate in the 
program. Those who agreed to participate in the PICC group were informed about 
the program and asked to attend on a specific date. Meanwhile, participants in both 
arms were scheduled for appointments from 1st May to 31st August 2023. The 
allocation was concealed from the researcher until data analysis was completed. 
In order to maintain the confidentiality of respondents, all research materials 
containing patients' information were coded and kept by the principal investigator. 
 
 
Withdrawal Criteria 
Participants can choose to withdraw at any time. Participants may be withdrawn if 
the research team deems that it is detrimental or risky for them to continue; 

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arrangements will be made for their future care. Withdrawn participants will not be 
replaced and will be included in the intention-to-treat analysis. 
Although subjects may withdraw from the study at any time and for any reason (or 
may be withdrawn at the Investigator’s discretion), subject withdrawal should be 
avoided as much as reasonably possible. In any case, appropriate follow-up for 
endpoints should be continued. Subjects who prematurely discontinue are not to 
be replaced. For subjects considered lost to follow-up, the case report form (CRF) 
must be completed up to the last visit performed. 
If the researcher found that a participant is no longer eligible or suitable for this 
study and decide to terminate the participant, or a participant decides to withdraw 
from this study, the following steps of subject withdrawal will be executed. 
 
The principal investigator will ask the participant who is withdrawing or terminated 
whether the participant intends to provide subsequent follow-up and further data 
collection after withdrawal or termination from the study's interventional portion. If 
the participant agrees to continue with subsequent follow-up and data collection, a 
new informed consent form for limited participation in this study should be 
obtained. If the participant does not agree to continue with subsequent follow-up 
and data collection, no medical records or other confidential records requiring 
informed consent will be accessed by any investigator of this study. Meanwhile, 
only the data collected before the participant’s withdrawal or termination can be 
accessed, reviewed and remained as part of the study database. Notably, such 
data should not be removed and should be included for data analysis to avoid a 
situation called “informative censoring”, which could undermine this study's validity. 
Data analysis techniques, namely intention-to-treat analysis or data imputation, will 
be performed to overcome the participants' withdrawal or termination. Lastly, the 
timing and reason for the withdrawal or termination of any participant will be 
reported by the principal investigator. 
 

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Randomisation and Blinding 
The Sarawak Pharmacy Service Division has been selected to perform the 
sequential allocation to ensure unbiased and systematic participant assignment, 
and the researcher will not be informed. Sequential allocation involves assigning 
participants to different groups or conditions in the order they are enrolled or 
become available, without any specific allocation scheme or randomisation, 
thereby minimising the risk of selection bias. The recruiter will be provided with the 
allocation, and they will assign participants to their respective groups. Participants 
will receive appointment dates for either PICC or DMTAC. This randomisation 
method is single-blinded, which means the researcher will remain blinded.  
For the blinding of researchers, it will be continued towards the stage of publication. 
During the post-intervention follow up, the researchers still are blinded by the 
participants' allocation, as the Sarawak Pharmacy Service Division keeps the 
participant list with group allocation. None of the instruments distributed to the 
participants will disclose their name and group assignment to assure the blinding 
among researchers who do the data analyses. Only after this study's results are 
published, the blinding or the codes will be broken through the return of the 
participants’ list to the principal investigator. The Sarawak Pharmacy Service 
Division will maintain the randomisation codes throughout the study without 
disclosing them to the researchers or the participants. 
No breaking code procedure is necessary for this study as the intervention of this 
study is educational and does not involve the investigation of medicinal products 
(IMP). Thus, the risk of suspected unexpected severe adverse reaction (SUSAR) 
or serious adverse event (SAE) would be a minimum or none. However, should 
any SAE or SUSAR happen during the study, the principal investigator will  report 
to the MREC and the physicians of the health clinic to rule out the possibility of 
such condition is due to this study before proceeding breaking the code. 

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Intervention Design (study visit and Procedure) 
The structured group-based intervention (SGBI) adopted by this study was 
formulated and employed by the Pharmaceutical Services Division of Sarawak 
State Health Department in promoting medication adherence among T2DM Malay 
patients. The official name of the intervention is “Pharmacy Integrated Community 
Care”. This SGBI employed an understanding self-care approach. It was 
specifically designed to complement the individual approach in improving 
understanding of T2DM medication management because group-based 
intervention (GBI) can engage more patients at once and build the fundamental 
capability of patients to adhere to prescribed medications within a shorter period 
as compared to the individual approach. Nevertheless, SGBI has numerous 
irreplaceable benefits (57) that individual approach might not have, including (1) 
validation; (2) normalisation of experience; (3) reduction of isolation; (4) sense of 
belonging; (5) enhanced self-esteem. 
The PICC is conducted within two to three hours each session and facilitated by 
one leading facilitator and three assistant facilitators. It has four modules to 
delivered each month consecutively.  The control arm will have a three-hour lecture 
on the same syllabus, however, without SGBI. 
Facilitators 
As aforementioned, the structured group-based intervention of this study is 
adopted from Pharmaceutical Services Division, Sarawak State Health 
Department. Facilitators who have experience conducting at least five times of the 
intervention will be eligible as facilitators for this study. Apart from training the 
facilitators to be familiar and consistent in conducting the intervention, the training 
of the facilitators also includes:  

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(1) learning how to eliminate concerns and questions the patients come across 
pertinent to medication adherence with a mnemonic tool “ADHERE” adapted from 
(58). 
• Acknowledgement: Acknowledge the concerns of patients. 
• Discuss: Discuss with patients on their concerns. 
• Handle: Handle concerns of patients promptly. 
• Evaluate: Assess patients health literacy and identify possible barriers to 
adherence. 
• Recommend: Suggest an appropriate and feasible solution to the patient.  
• Empower: Elicit patients’ willingness to adhere to medications for the long 
term.  
(2) learning what are the Dos and Don’ts when communicating with 
participants with guidelines (59): 
• Adopt a friendly attitude and not a business-like attitude 
• Avoid medical jargon 
• Use short sentences 
• Give explicit instruction and repeat the instructions 
• Give specific and detailed information 
• Ensure the patients understand by asking them to repeat what had been said 
(3) learning patient-centred communication as advocated by (60). It encourages 
the facilitators to be active listeners and encourage them to think, understand the 
problems about medication adherence they face and decide to act. It also involves 
nonverbal communication skills such as nodding and making eye contact to show 
genuine interest and concern on participants' issues. 
 

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To ensure the consistency and correctness of facilitators in conducting the 
intervention according to the intervention content and applying the communication 
skills learned, three sessions of the interventions before the actual study will be 
observed and assessed by the researchers on their performance in terms of 
coverage of all learning topics, consistency in conducting the intervention, 
communication with participants and responsiveness to participants’ concerns. 
Besides, the facilitators will also be asked to evaluate their performance on the 
same aspects. All the aspects mentioned above are required to achieve 90%-
100% to qualify as facilitators for this study.  
As a whole, each session will require one (1) main facilitators and three (3) 
assistant facilitators to facilitate the program. The number of participants for each 
structured group-based intervention session is fixed between 6 to 10 participants. 
Notably, all the facilitators are the pharmacists who serve under the 
Pharmaceutical Services Division of the Sarawak State Health Department. The 
contents of it are depicted in Table 1:

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Table 1: Contents of structured PICC programme 
 MODUL1: INTRODUCTION TO DIABETES 
 
Number of participants: 10 people (minimum)  
 
 
 
 
 
 
 
      
Objective: 
1. Create a support group that helps increase patients’ self-motivation in controlling diabetes 
2. Recognize and understand diabetes 
3. Share the information learned among the participants 
 
Duration 
Objective 
Activity 
Person in-
charge 
Materials  
Procedure 
10 minutes 
Registration 
- 
- 
• Consent form 
• Patient 
• Patient’s Information 
record PICC 
• myPICC Activity Book 
• Write the name on the card (name 
card) 
• Distribute consent forms (2 copies) 
to participants, one copy PF keep, 
one copy participants, keep 
• Distribute “PICC Participant 
Information Record” & “MyPICC 
Activity Book” to participants 
• Ask them to fill in demographic data 
in both books 
5 minutes 
Briefing PICC 
Lecture 
Head 
facilitator 
- 
• Information about PICC (objective, 
etc.) 

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30 minutes 
Clinical impact 
monitoring 
Health 
screening 
Medical 
team 
• Health screening kit 
• Outsource medical team 
(MA / Nurse / etc.) to 
help do the health 
screening 
• Set up counters to do the 
health screening 
• Explain to participants why we need to 
do a health screening, what are the 
things or parameters we are going to 
measure 
• The medical team will conduct 
the following health screenings: 
• Body Mass Index (BMI) 
• Blood sugar levels (fasting blood 
sugar and HbA1c) 
• Blood pressure level 
15 minutes 
Ice-breaking 
Group 
activity 
Head 
facilitator 
• Cards for name tags 
• Participants are divided into 
groups (maximum five groups) 
• Each group will be given a card 
for participants to write their 
names. 
• The facilitator will start the ice-
breaking session by asking 
questions: 
1. Name 
2. Origin 
3. Who do you live with (alone / 
family or with non-family) 
4. o History of diabetes 
 
25 minutes 
Participants’ 
understanding 
of diabetes 
 
Brainstorm
ing & 
Clustering 
 
Facilitator 
• Card 
• Pen marker 
• Large paper (if any) 
• Sellotape 
• The facilitator gives out one card and 
one pen to 2 participants (2 
participants share one card and one 
pen, discuss) 
• The facilitator asks some questions: 
o Participants’ perceptions of 
diabetes 
      o Factors/causes of getting diabetes 

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      o Expectations or plans of 
participants  
         when joining PICC 
• Participants’ answers are recorded 
on the card. 
• Give participants 1 minute to write 
down the answer/idea on the card 
• After that, each facilitator arranges 
the ideas (clustering) by 
category/problem on Large paper or 
whiteboard or wall with stickers 
(sellotape) 
• The facilitator rectifies the 
“expectations or plans.” 
• Perceptions, factors, rectify later after 
the module 1 lecture 
20 minutes 
Module 1: 
Introduction to 
Diabetes 
Lecture 
Facilitator 
• Module 1 Slides: 
Introduction to Diabetes 
• myPICC Activity Book 
• Other teaching aids 
• Briefing and discussion sessions 
conducted by the facilitator using 
Module 1: Introduction to Diabetes 
(slides or checklists) 
• The facilitator guides the participants 
to complete the activities for Module 
1 in the myPICC Activity Book. 
• Assist the participants in doing the 
activities in the MyPICC Activity 
Book after almost every slide. (page 
4 – 7) 
• The facilitator should also comment 
on the participants ’understanding of 
diabetes based on the ideas on the 
cards that have been clustered. 

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• Representatives of participants from 
each group may be asked to provide 
additional comments. 
10 minutes 
Module 1: 
Introduction to 
Diabetes 
Group 
work 
Facilitator 
• Module 1 Slides: 
Introduction to Diabetes 
• myPICC Activity Book 
 
• The facilitator arranges the 
appropriate place as: 
1. Blood vessels (road) 
2. Cell (home) 
• The facilitator identifies the role of 
the participant in the role-play 
session: 
1. Glucose (passenger) – 8 
participants 
2. Insulin (car) – 2 participants 
• Perform role-play activities for two 
situations: normal individuals & 
diabetics. 
5 minutes 
Conclusion for 
session 1 
Lecture 
Facilitator 
• Module 1 Slides: 
Introduction to Diabetes 
• myPICC Activity Book 
• Record the date of session 2 in 
myPICC Activity Book 
• The facilitator reminded the 
participants to bring their medicine in 
session 2. 

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5 minutes 
Participant 
comprehensio
n test 
Pop quiz 
Facilitator 
• myPICC Activity Book 
• Each participant is asked to 
complete a quiz question (page 8) 
included in the myPICC Activity Book 
• The facilitator will check the answers 
given. 
• Scores obtained will be recorded on 
page 2 MyPICC Activity Book & 
Page 2 Participant Information 
Record book. 
 
 
 
 
 
 
MODULE 2: TAKING ANTIDIABETES MEDICINES 
Number of participants: 10 people (minimum) 
Target group: PICC participants 
Objective: 
1. Recognize and understand the indications of DM Medication 
2. Explain the concept of 5B in taking DM medication 
3. Share the information learned among the participants 
Duration 
Objective 
Activity 
Person in-
charge 
Materials  
Procedure 
30 minutes 
Clinical impact 
monitoring 
Health 
screening 
Medical 
team 
• Health screening kit 
• Outsource the medical 
team (MA / Nurse / etc.) to 
help do the health 
screening 
• The medical team will conduct the 
following health screenings: 
1. Body Mass Index (BMI) 
2. Fasting blood sugar (fasting blood 
sugar) 
3. Blood pressure level 

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• Set up counters to do the 
health screening 
15 minutes 
Recap for 
session 1 
Generate 
ideas 
Facilitator 
• Cards & Pens 
• The facilitator obtains feedback from 
participants on session 1. 
• Optional: Ask participants/patients to 
save the book (cannot refer to the 
book for answers) 
• 2 – 3 participants (patients) are given 
1 card & 1 pen 
• After that, the facilitator asks 
questions: 
1. How does diabetes occur? 
2. What causes diabetes? 
3. What is the target sugar level for 
diabetics? 
• Patients are given 1 minute to write 
the answer on the card. 
• Cards will be collected and clustered 
on a Large paper/wall/whiteboard. 
• The facilitator will comment based on 
the participants’ answers. 
 
10 minutes 
Participants’ 
understanding 
of diabetes 
medication 
intake 
 
Brainstormi
ng 
 
Facilitator 
• Card 
• Pen marker 
• Mahjong paper (if any) 
• Sellotape 
• The facilitator gives out one card and 
one pen to 2 participants (2 
participants share one card and one 
pen, discuss) 
• The facilitator asks some questions: 
1. How do you take diabetes 
medication? (before, during or 
after meals) 

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2.  Where do you store diabetes 
medicine? 
• Participants’ answers are recorded 
on the card. 
• Give participants 1 minute to write 
down the answer/idea on the card 
• After that, each facilitator arranges 
ideas (clustering) according to 
categories/answers on Large paper 
or whiteboard or wall with stickers 
(sellotape) 
• Rectify later after the module 2 talks 
30 minutes 
Module 2: 
Antidiabetic 
Medication 
Management 
and 
conclusions 
for session 2 
Lecture 
Facilitator 
• Module 2 Slide: Taking 
Antidiabetic Medications 
• myPICC Activity Book 
• Other teaching aids 
• Briefing and discussion sessions 
conducted by the facilitator using 
Module 2: Taking Diabetes 
Medication (slides or checklists) 
• The facilitator guides the participants 
to complete the activities for Module 
2 in the myPICC Activity Book. 
• Assist the participants in doing the 
activities in the MyPICC Activity Book 
after almost every slide. (pages 10 – 
15) 
• The facilitator should also comment 
on the participants’ understanding of 
taking diabetes medication based on 
the ideas on the cards that have 
been clustered. 
• Representatives of participants from 
each group may be asked to provide 
additional comments. 
• Optional: Brainstorming & clustering 
for factors causing hyperglycemia 

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and hypoglycemia can be done. 
• Dates for session three will be stated 
in the myPICC Activity Book. 
5 minutes 
Participant 
comprehensio
n test 
Pop quiz 
  Facilitator 
• myPICC Activity Book 
 
• Each participant is asked to 
complete the quiz (page 16) included 
in the myPICC Activity Book 
• The facilitator will check the answers 
given. 
• Scores obtained will be recorded on 
page 2 MyPICC Activity Book & 
Page 2 Participant Information 
Record book. 
MODULE 3: COMPLICATIONS OF DIABETES 
Number of participants: 10 people (minimum) 
Target group: PICC participants 
Objective: 
1. Recognize and understand the complications of diabetes 
2. How to prevent and control the complications of diabetes 
3. Share the information learned among the participants 
 
Duration 
Objective 
Activity 
Person in-
charge 
Materials  
Procedure 

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30 minutes 
Clinical impact 
monitoring 
Health 
screening 
Medical 
team 
• Health screening kit 
• Outsource the medical 
team (MA / Nurse / etc.) to 
help do the health 
screening 
• Set up counters to do the 
health screening 
• The medical team will conduct the 
following health screenings: 
1. Body Mass Index (BMI) 
2. Fasting blood sugar (fasting 
blood sugar) 
3. Blood pressure level 
15 minutes 
Recap for 
session 2 
Generate 
ideas 
Facilitator 
• Card 
 
• The facilitator gets feedback from the 
participants about session 2. 
• Optional: Ask participants/patients to 
save the book (cannot refer to the 
book for answers) 
• 2 – 3 participants (patients) are given 
1 card & 1 pen 
• The facilitator asks questions: 
1. Types of diabetes medications 
2. Time of insulin intake 
3. Symptoms of hypoglycemia and 
hyperglycemia 
• Patients are given 1 minute to write 
the answer on the card. 
• Cards will be collected and clustered 
on a Large paper/wall/whiteboard. 
• The facilitator will comment based on 
the participants’ answers. 
 
10 minutes 
Participants’ 
understanding 
of the 
complications 
of diabetes 
 
Brainstormi
ng 
 
Facilitator 
• Card 
• Pen marker 
• Mahjong paper (if any) 
• Sellotape 
• The facilitator gives out one card and 
one pen to 2 participants (2 
participants share one card and one 
pen, discuss) 
• The facilitator asks some questions: 
1. Why do complications of diabetes 
occur? 
2. What are the common 

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complications of diabetes you 
see in people with diabetes? 
• Participants’ answers are recorded 
on the card. 
• Give participants 1 minute to write 
down the answers/ideas on the card 
• After that, each Facilitator arranges 
ideas (clustering) by category/answer 
on Large paper or whiteboard or wall 
with stickers (sellotape) 
• Rectify later after the module 3 
Lecture 
30 minutes 
Module 3: 
Diabetes 
Complications: 
Description 
and 
conclusions 
for session 3 
Lecture 
Ketua Sesi / 
Facilitator 
• Module 3 Slide: 
Complications of Diabetes 
• myPICC Activity Book 
• Other teaching aids 
• Briefing and discussion sessions 
conducted by the facilitator with the 
help of Module 3: Diabetes 
Complications (slides or checklists) 
• The facilitator guides the participants 
to complete the activities for Module 
3 in the myPICC Activity Book. 
• Assist the participants in doing the 
activities in the MyPICC Activity Book 
after almost every slide. (pages 18 – 
20) 
• Emphasise the “information” on foot 
care on page 20 in the MyPICC 
Activity Book. (not in the slide) 
• The facilitator should also comment 
on the participants’ understanding of 
the complications of diabetes based 
on the ideas on the cards that have 
been clustered. 
• Representatives of participants from 
each group may be asked to provide 

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additional comments. 
• The date for session 4 will be stated 
in the myPICC Activity Book. 
5 minutes 
Participant 
comprehensio
n test 
Pop quiz 
  Facilitator • 
myPICC Activity Book 
 
• Each participant is asked to 
complete a quiz question (page 21) 
included in the myPICC Activity 
Book. 
• The facilitator will check the answers 
given. 
• Scores obtained will be recorded on 
page 2 MyPICC Activity Book & 
Page 2 Participant Information 
Record book. 
MODULE 4: PRACTICE A HEALTHY LIFESTYLE 
 
Number of participants: 10 people (minimum) 
Target group: PICC participants 
Objective: 
1. Provide exposure to the diet and healthy lifestyle of diabetics. 
2. Share the information learned among the participants. 
 
Duration 
Objective 
Activity 
Person in-
charge 
Materials  
Procedure 

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30 minutes 
Clinical impact 
monitoring 
Health 
screening 
Medical 
team 
• Health screening kit 
• Outsource the medical 
team (MA / Nurse / etc.) 
to help do the health 
screening 
• Set up counters to do 
the health screening 
• The medical team will conduct the 
following health screenings: 
1. Body Mass Index (BMI) 
2. Fasting blood sugar (HbA1c) 
3. Blood pressure level 
20 minutes 
Morning 
exercise 
Aerobic 
Physiot
herapist 
• Music 
• Each participant will participate in an 
exercise led by an aerobics 
instructor. 
5 minutes 
Recap for 
session 3 
Generate 
ideas 
Facilitator 
• Card 
• The facilitator gets feedback from the 
participants about session 3. 
• 2 – 3 participants (patients) are given 
1 card & 1 pen 
• The facilitator asks questions: 
1. How to reduce the risk of getting 
diabetes complications? 
• Patients are given 1 minute to write 
the answer on the card. 
• Cards will be collected and clustered 
on a Large paper/wall/whiteboard. 
• The facilitator will comment based on 
the participants’ answers. 
10 minutes 
Healthy 
lifestyle 
Lecture 
(Slide no. 
36 – 40) 
Physiothera
pist 
• Module 4 Slides: 
• Practice healthy lifestyle 
• myPICC Activity Book 
• Briefing and discussion sessions 
conducted by physiotherapists using 
Module 4: Practicing a Healthy 
Lifestyle (slides or checklists) 
• Participants complete the activities 
for Module 4 in the myPICC Activity 
Book. (pages 23 – 24) 

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35 minutes 
Diet for 
diabetics 
Lecture 
(Slide no. 
41 – 45)   
Dietician 
• Module 4 Slides: 
Practicing a Healthy 
Lifestyle 
• Teaching aids 
(example: bowl, plate 
or spoon to measure 
the quantity of food) 
• myPICC Activity Book 
• Information sessions and discussions 
conducted by nutrition science 
officers using Module 4: Practicing a 
Healthy Lifestyle (slides or checklists) 
• The facilitator guides the participants 
to complete the activities for Module 
4 in the myPICC Activity Book. (page 
24 – 26) 
• Demonstrations are shown to 
reinforce participants ’understanding. 
15 minutes PICC summary 
Generate 
ideas 
Facilitator 
• Card & pen 
• Large paper 
• Adhesive tape 
• Participants will be divided into small 
groups. 
• Each group will be given 3 pieces of 
cards, and the answer is written on 
the card. 
• The facilitator will ask questions: 
1. What causes diabetes? 
2. How to control diabetes? 
3. What is the targeted sugar level 
for diabetics? 
• Cards will be collected, and the 
facilitator will do clustering. 
• The facilitator will comment on the 
answers from the participants. 
• The facilitator will make a summary 
of the PICC and the performance of 
the participants throughout 
participating in the PICC. 

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5 minutes 
Participant 
comprehensio
n test 
Pop quiz 
Facilitator 
• myPICC Activity Book 
• Each participant is asked to 
complete the quiz questions included 
in myPICC Activity Book (page 27) 
• The answers given will be checked 
by the facilitator. 
• The marks obtained will be recorded 
in the PICC Participant Information 
Record and MyPICC Activity Book. 
5 minutes 
PICC Program 
Feedback 
Customer 
satisfactio
n survey 
Facilitator 
• Google Form  
• Each participant is asked to 
complete a customer satisfaction 
survey as in the link. (page 28 
MyPICC Activity Book) 
10 minutes 
Certificate of 
Participation 
Presentation 
Session 
- 
- 
• Certificate 
• Certificate of participation is given to 
all participants who successfully 
attend 3 of the 4 sessions of the 
PICC program. 
 
 
 
 
 
 

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Content of Control Group 
Participants who are assigned to the control group will received DMTAC sessions. 
Baseline HbA1C will be collected on the date of the talks, while an appointment 
given in August for the follow-up HbA1C.  After that, they will be dismissed and 
having usual care provided by the health clinic as before without any changes. 
 
Study Timeline and Procedure 
The researchers of this study will begin to screen and recruit respondents between 
1st May to 31st May 2023. The trials will be from 1st to 31st August 2023 for all 
facilities. The baseline measurement of HbA1C will be carried out from 1st to 31st  
May 2023 subsequently by until the fourth session complete. The study timeline is 
illustrated as in Figure 3 and the study procedure is illustrated in Figure 3. 
 
 
 
 
 
 
 
 
Figure 3: Study timeline 
 
Recruitment  
Intervention 
group (PICC) 
Control group 
(DMTAC) 
Randomization (sequential allocation) 
First Module 
PICC (pre 
HBA1C taken) 
First DMTAC 
appointment 
(pre HBA1C 
Subsequent module each 
month (post HbA1C on 
last module in August) 
Post HbA1C (in 
August) 
1st May -31st  May 2023 
1st June- 31st August 2023 

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Case report form (CRF) 
All the items in the case report form are originally in Malaysia national language, 
which is Bahasa Malaysia. There are two CRF which are MyPICC Activity Book 
that is for participants to fill the quizzes on each module, and the Record book 
PICC that contains patients details, HbA1C, marks for quizzes, medication history, 
pharmaceutical care issues and referral to other facilities. 
Treatment Fidelity 
Treatment fidelity of the SGBI will be evaluated using the concept and strategies 
developed by the Treatment Fidelity Workgroup of the National Institutes of Health 
Behavior Change Consortium (61). The framework of treatment fidelity strategies 
for this study is depicted in Table 2:

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Table 2: Framework of treatment fidelity strategies 
Components  
Goal 
Strategies 
Study design 
Ensure the same 
treatment dose within 
conditions and 
equivalent dose across 
conditions. 
 
 
(1) SGBI is designed to be completed within four sessions.  
(2) The use intervention manual will ensure all facilitators consistently conduct 
the intervention. 
(3) Observation on a mock intervention conducted by involved facilitators 
before researchers will do the actual study to assess the consistency and 
appropriateness in conducting the intervention. Feedback will be given to the 
facilitators by observers after the observation. The facilitators will also discuss 
the issues faced during the intervention with the researchers. 
(4) All facilitators must adhere to the time allocated for each activity throughout 
the intervention. 
Plan for 
implementation 
setbacks. 
Have extra four qualified and trained facilitators in case of unavailability of the 
involved facilitators. 
Provider training Standardise training. 
 
All the qualified and involved facilitators, together with four backup facilitators, 
will be trained to ensure consistency in conducting the intervention. All 
sessions of intervention will be observed while to ensure consistency and 
performance of the involved facilitators. 
Ensure provider skill 
acquisition. 
A scoring scale to assess the qualification and consistency of facilitators in 
conducting the intervention will be practised. 

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Minimise “drift” in 
provider skills. 
 
During the actual study, researchers will still observe the intervention 
conducted by facilitators and will be video recorded to ensure the consistency 
of the intervention. Should the researcher observe less than 90% of 
consistency compared to training sessions, the reasons that cause the 
inconsistency will be investigated and reported. 
Accommodate provider 
differences. 
 
All the facilitators are pharmacists who work in Pharmaceutical Services 
Division, Sarawak State Health Department. Hence, the facilitators have a 
similar knowledge background and are considered experts related to the study. 
Treatment 
delivery 
Control for provider 
differences. 
Facilitators having a similar background and having same training at the same 
time 
Reduce differences 
within treatment. 
Scripted intervention protocol is available and used by facilitators 
Ensure adherence to 
the treatment protocol. 
 
During the actual study, researchers will still observe the intervention 
conducted by facilitators and will be video recorded to ensure the consistency 
of the intervention. Should the researcher observe less than 90% of 
consistency compared to training sessions, the reasons that cause the 
inconsistency will be investigated and reported. 
Minimise 
contamination between 
conditions 
The patient allocated randomly while the researcher blinded throughout the 
trial. 
Ensure participant 
comprehension. 
(1) The participant understanding of the message will be evaluated with the 
scales developed to measure the intervention's impact on psychosocial 
variables of participants. Comparison between the intervention group and 

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Treatment 
receipt 
 
control group will show whether the improvement in the psychosocial variables 
is due to chance or is because of the intervention. 
(2) Qualitative interview after the intervention will enable the researchers to 
know how the intervention impact their medication-taking behaviour. 
Ensure participant 
ability to use cognitive 
skills. 
 
(1) Conduct structured interviews with 
participants;  
(2) Facilitators work with 
participants until they can demonstrate correct medication-taking skills. 
(3) Hypothetical situations that participants may face in real life will be 
addressed during group discussion and sharing their reasons for 
nonadherence and the method they will adopt to overcome the problem. 
Ensure participant 
ability to perform 
behaviourally 
skills. 
Facilitators work with participants until they can demonstrate correct 
medication-taking skills. 
 
Enactment 
of 
treatment skills 
Ensure participant use 
of cognitive skills. 
Quizzes and a workbook will navigate the participant to comprehend the 
medication-taking skills. 
Ensure participant use 
of behavioural skills 
HBA1c will be measured on the first and the last session of intervention to 
ensure the messages conveyed through the intervention are translated into 
action and such action is maintained. 
 

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Outcome measurement 
Primary outcome: 
Laboratory-analysed HbA1C will be the primary outcome. Data on glycaemic 
control will be collected from patient records while demographic details, 
comorbidities, duration and diabetes complications assessed by using a CRF 
once participants allocated to the treatment or control group. Facilitators will 
conduct the point of care before starting the module on the day of the program. 
Thus, the facilitators are not blinded. 
Secondary outcome: 
Knowledge and understanding of DM medication management will be 
evaluated by using the quizzes in the PICC program. The quiz will be evaluated 
in-situ thus allowing the facilitator to rectify patient’s misconception. After the 
programs ends, the marks of the quiz will be recorded in the CRF. Thus, the 
facilitators are not blinded. 
 
Statistical Analysis Plan 
 
Data will be computed by using SPSS. The case report form only collects 
descriptive data which the content validity will be examined before the actual 
study through three experts’ opinions. Differences between groups at baseline 
and assess the differences of DM knowledge and HbA1c in the intervention and 
control groups will be analysed using t-test and chi-square test. We will do an 
intention-to-treat analysis that includes all participants. In order to examine 
relationships between data, we will use Pearson’s or Spearman rho.    
 
Ethical Consideration 
All the data are restricted to the principal investigators and solely used for 
research purposes. The study will be conducted in compliance with ethical 
principles outlined in the Declaration of Helsinki and the Malaysian Good 
Clinical Practice Guideline. This trial will be registered with the Medical 
Research and Ethics Committee (MREC), National Institutes of Health 

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Malaysia, before the actual study. Besides, it will be registered with 
ClinicalTrials.gov following the approval from MREC. 
 
Informed Consent/Assent Process 
 
The informed consent forms will be first given, and the purpose of the study will 
be explained to the respondent to obtain permission to participate in the study. 
They will be informed that their participation is voluntary, and they have full right 
to stop or refused to continue the study at any point of the survey. No penalty 
or benefits would be given once they stopped or completed the study. All the 
information given is strictly for research purposes and accessible by principle 
and co-investigators only. Participants would be informed through a phone call 
if there were new information relevant to the consent. 
Risk and benefit to study participants 
As stated in the literature above, there are no severe side effects known to be 
caused by the PICC programmed. The study procedures are all routine 
procedures for the group based intervention studied. There is thus a minimal 
risk for subjects. 
This study does not present any direct benefit to the participants. However, the 
study does provide a better understanding of the disease/condition studied.  
Risk-Benefit Assessment 
As stated above, there is minimal risk from the investigational product and study 
procedures. Study findings shall potentially significantly improve treatment 
outcomes. The expected benefit outweighs the minimal risk to subjects, and 
thus this study should be supported. If any injuries do occur due to participating 
in the study, treatment for such injuries shall be provided or paid for by the 
sponsor. 
 
 
 

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Privacy and Confidentiality 
All participant information will be treated as strictly confidential. Participant have 
access to their personal information, however not study data. Personal 
information will be coded to ensure the confidentiality of the participants, and 
no individuals will be identifiable in any research material, reports or 
publications. No information collected will be shown to anyone apart from the 
research team. Data from the study will be stored securely in locked cabinets, 
and electronic data will be kept on password-protected drives accessible only 
by the research team. Permission to share information with appropriate health 
professionals will be sought if health concerns arise for participants. 
 
The dignity and privacy of the participants are always respected and upheld by 
the researchers of this study as both are the core elements of research ethics 
(62). Not only the participants will be explained about their rights throughout the 
study as mentioned above, but they also will be informed that they have the 
right to decide how much information which is required by this study to disclose. 
Such information includes their physical status, health, social network, thoughts 
and feelings.  
 
Nevertheless, all the participants’ names will be kept on a password-protected 
database and linked only with a study identification number for this research. 
The identification number instead of respondents’ identifiers will be used on 
subject datasheets. All data will be entered into a computer that is password 
protected. On completion of the study, data in the computer will be copied to 
CDs, and the data in the computer will be erased. The CDs is password-
protected, and any hardcopy data will be stored in a locked office of the 
investigators and maintained for a minimum of three years after completing the 
study. The CDs and data will be destroyed after that period of storage. 
Respondents will not be informed about the study’s exaggerated data 
individually, but this study's findings will be published. Subjects are given 
access to their personal information and study data. 
 
 

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Conflict of interest 
All the investigators declare that they have no conflict of interest. 
Notwithstanding, the principal investigator will take the responsibility to report 
any conflict of interest that emerges during the study. 
 
Publication Policy 
No personal information will be disclosed, and subjects will not be identified 
when the findings are published. 
Termination of Study 
This study may be temporarily suspended or prematurely terminated if there is 
sufficient reasonable cause. Written notification, documenting the reason for 
study suspension or termination, will be provided by the suspending or 
terminating party to the Investigator, the Sponsor and the Institutional Review 
Board (IRB), as appropriate.  If the study is prematurely terminated or 
suspended, the Investigator will promptly inform the IRB and provide the 
reason(s) for the termination or suspension. Circumstances that may warrant 
termination or suspension include, but are not limited to:  
• Determination of unexpected, significant, or unacceptable risk to participants  
• Demonstration of efficacy that would warrant stopping  
• Insufficient compliance to protocol requirements  
• Data that are not sufficiently complete or evaluable  
• Determination of futility  
The study may resume once concerns about safety, protocol compliance, data 
quality are addressed and satisfy the Sponsor and the IRB. 
The sponsor may decide to terminate the study at any time. Subjects will be 
informed if the study is terminated, and follow-up visits will be arranged if 
needed. 

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Part III: Qualitative Survey on PICC Program 
 
Study Design 
 
The qualitative interviews with patients with PICC will be semi-structured, 
audio-recorded, transcribed and thematically analysed using Excel to identify 
outcomes and determine the themes described. Ten selected participants 
conducted one month after the intervention and in-depth interviews with two 
main facilitators and two managerial officers in charge of the Program 12 
months after the intervention.  We will explain to all participants the study's 
objective and be given informed consent before the interviews. The literature 
review and patient interviews will be combined and prioritised to determine what 
the most important outcomes are in PICC to patients. 
 
We conduct this study at the study site of each division. Ten participants were 
purposively sampled to cover a maximum variation of sampling based on the 
following criteria: (1) able to speak Malay or English; (2) had a written diagnosis 
of T2DM for at least one year; and (3) had no cognitive or hearing impairments.  
 
An in-depth interview was chosen as the method for data collection as it allowed 
the researchers to explore participants’ personal experiences. A semi-
structured interview guide was developed with open-ended and some probing 
questions were asked to clarify specific issues raised by the participants. Pilot 
interviews were carried out first in the presence of a senior qualitative 
researcher to ensure the researcher’s interviewer technique was appropriate 
and to test the protocol guide. After the first two interviews, the protocol guide 
was revised.  
 
 
 
 
 
 

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The research questions addressed are: 
− RQ1: How did this program help you in improving your medication 
adherence? 
− RQ2: What is(are) the weakness(es) of the program, and what could be done 
to improve it? 
− RQ3: Is there anything else you would like to share with me about the 
program's impact on your medication-taking behaviour or any suggestions to 
improve the Program? 
In terms of process evaluation purposes, RQ1 is a positive experience about 
the impact of the program and RQs 2  is a negative case/experience and 
suggestions, and 3 is a closing question. 
All of the interviews took place in a private room at the clinic and were recorded 
with an audiotape recorder. The interviews were conducted either in Malay or 
English and lasted for about 35–50 minutes. A basic demographic profile was 
obtained before each interview. The audio recording will be anonymous, and 
there will be no mention of personal identifying information such as names, IC 
numbers, etc., during the interview. The audio recording is for transcription 
purposes and will not be copied/sent to any other individual or used for any 
other purpose. After transcription, the audio recording will be disposed of 
securely. 
 
We conduct the data analysis simultaneously with the data collection. At the 
end of each interview, the interviewer summarises what was understood by the 
participants and asked them to check for any missed or inaccurate information. 
After the interview session ended, a debriefing session held where the 
researcher wrote down a summary and reflections. The interview then 
transcribed and compared with the audio recording to ensure its accuracy. The 
text then transferred to Excel for analysis. Subsequently, the researcher heard 

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the audio recording and read the transcript to understand the whole data before 
beginning to code the text.  
 
Thematic analysis was applied, and coding was done in several steps. Initially, 
a descriptive level of coding was done to a segment of text, which was either a 
few phrases, one single or several sentences, or paragraphs. The research 
team then discussed the code labels, and some parts of the text were re-coded 
again. After several transcripts, an interpretative level of coding was performed; 
later, the codes with similar meanings were grouped. This process continued 
till subthemes and themes were developed. After the sixth interview, the 
preliminary themes and subthemes were reviewed and discussed among the 
research team. Some codes were re-categorized, and the subthemes, as well 
as themes, were further redefined. The data collection concluded at the tenth 
interview as the data reached a saturation point where no new themes 
emerged. 
 
  Analysis Plan 
 
The qualitative data collected through the semi-structured interview, the 
constant comparative method for qualitative analysis with the assistance of 
ATLAS.ti, will be used to identify the themes related to the questions. 
 
Ethical Consideration 
All the data are restricted to the principal investigators and solely used for 
research purposes. The study will be conducted in compliance with ethical 
principles outlined in the Declaration of Helsinki and the Malaysian Good 
Clinical Practice Guideline. This qualitative survey will be registered with the 
Medical Research and Ethics Committee (MREC), National Institutes of Health 
Malaysia, before the actual study.   
Informed Consent/Assent Process 

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The informed consent forms will be first given, and the purpose of the study will 
be explained to the respondent to obtain permission to participate in the study. 
They will be informed that their participation is voluntary, and they have full right 
to stop or refused to continue the study at any point of the survey. No penalty 
or benefits would be given once they stopped or completed the study. All the 
information given is strictly for research purposes and accessible by principle 
and co-investigators only. Participants would be informed through a phone call 
if there were new information relevant to the consent. 
Privacy and Confidentiality 
The dignity and privacy of the participants are always respected and upheld by 
the researchers of this study as both are the core elements of research ethics 
(62). Not only the participants will be explained about their rights throughout the 
study as mentioned above, but they also will be informed that they have the 
right to decide how much information which is required by this study to disclose. 
Such information includes their physical status, health, social network, thoughts 
and feelings.  
Nevertheless, all the participants’ names will be kept on a password-protected 
database and linked only with a study identification number for this research. 
The identification number instead of respondents’ identifiers will be used on 
subject datasheets. All data will be entered into a computer that is password 
protected. On completion of the study, data in the computer will be copied to 
CDs with password-protected, and the data in the computer will be erased. CDs 
and any hardcopy data will be stored in a locked office of the investigators and 
maintained for a minimum of three years after completing the study. The CDs 
and data will be destroyed after that period of storage. Respondents will not be 
informed about the study’s exaggerated data individually, but this study's 
findings will be published. Subjects are given access to their personal 
information and study data. 
 

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Publication Policy 
No personal information will be disclosed, and subjects will not be identified 
when the findings are published.

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6. 
Gantt Chart 
 
 
 
 

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7. 
Estimated Costs 
Items 
Quantity 
Cost (RM) 
Remarks 
White A4 Paper 
30 Rims 
(30 x RM10.00) 
300.00 
To print journal articles, 
questionnaires 
and 
reports. 
Printer Toner (HP LaserJet 
1300) 
Two units 
(2 x RM300.00) 
600.00 To 
print 
journals 
articles and reports. 
Flash Drives 4G (Kingston/ 
Apacer) 
Two units 
(2 x RM100.00) 
200.00 
To save journal articles. 
For the preparation of 
report writing. 
Travelling Expenses: 
- 
Conducting 
face-to-
face survey and PICC 
program 
 
- 
15, 000.00 - 
Enumerators for trials 
9 sites (Total 
payment per 
enumerator-
Rm200) 
5,200.00 
4 
session 
each, 
2 
enumerator 
per 
session. 
 
26 
trained 
facilitators/enumerators 
will be involved. 
The 
enumerator 
for 
the 
qualitative survey 
12 interviews (RM 
200 per interview) 
2,400.00  
Translation job 
- 
500.00 
To translate journals 
(other 
than 
English 
language articles) 
 
Transcriber for qualitative 
survey 
12 transcriptions 
(RM 100 each) 
1200.00  
Publication 
 
Proofreading 
 
 
4 research papers 
(RM 1000 each) 
 
 
4,000.00 
 
Laboratory-analysed HbA1C 9 reagent for 9 
site 
4,550.00  

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Lancet 
52 box (20’s) 
520.00  
Alcohol swab 
4 box (100’s) 
20.00  
TOTAL (RM) 
34,490.00  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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9. 
References 
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Organization WH. World Health Organization Global Report on Diabetes. Geneva: World Health 
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2. 
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Diabetes–Global Burden of Disease and Forecasted Trends. Journal of epidemiology and global health. 
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3. 
Cockram CS. Diabetes mellitus: perspective from the Asia–Pacific region. Diabetes research and 
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4. 
Zheng Y, Ley SH, Hu FB. Global aetiology and epidemiology of type 2 diabetes mellitus and its 
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Chuang LM, Tsai S, Huang B, Tai T. The status of diabetes control in Asia—a cross‐sectional survey 
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Harding JL, Pavkov ME, Magliano DJ, Shaw JE, Gregg EW. Global trends in diabetes complications: 
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Vermeire E, Van Royen P, Coenen S, Wens J, Denekens J. The adherence of type 2 diabetes 
patients to their therapeutic regimens: a qualitative study from the patient's perspective. Practical 
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8. 
Cramer JA. A systematic review of adherence with medications for diabetes. Diabetes care. 
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Misra A, Gopalan H, Jayawardena R, Hills AP, Soares M, Reza‐Albarrán AA, et al. Diabetes in 
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Cheng LJ, Wang W, Lim ST, Wu VX. Factors associated with glycaemic control in patients with 
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Nurumal MS, Jamaludin TSS, Mohammad NM, Hasan MKC, Win KK. A Review on Knowledge of 
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Tay JHT, Jiang Y, Hong J, He H, Wang W. Effectiveness of lay-led, group-based self-management 
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adults with type 2 diabetes: A systematic review and meta-analysis. International Journal of Nursing 
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Zare S, Ostovarfar J, Kaveh MH, Vali M. Effectiveness of theory-based diabetes self-care training 
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Health IfP. National Health and Morbidity Survey 2011 (NHMS 2011). Vol II: Non-Communicable 
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Appendix 1 
 
Data extraction form for Systematic Review 
  
Study design 
 
Trial characteristics 
 
Intervention details 
 
Participant characteristics 
 
outcome measures 
 
results 
 
random sequence generation 
 
allocation concealment 
 
blinding of participants and personnel 
 
blinding of outcome assessment 
 
incomplete outcome data 
 
selective reporting 
 
other bias 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 2 
Data Collection form during the trials 
 
 
 

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INFORMATION SHEET 
Study Title: 
Effectiveness of Pharmacy Integrated Community Care (PICC) improving 
Hemoglobin A1c (HBA1C) and Knowledge in diabetes mellitus (DM) 
education program 
Protocol No.: 
 
Sponsor:  
Pharmaceutical Service Division, Sarawak State Health Department 
Investigator Name: 
Kamarudin Bin Ahmad 
Investigator Contact No. 
0128789869 
 
Consumer Information: 
Name:  
 
Telephone No.: 
 
Address: 
 
Identity Card Number: 
 
 
 
Introduction  
 
You have been invited to participate in a research study to examine the effectiveness of a group-based 
intervention in improving knowledge and self-care in diabetes with underlying Type 2 Diabetes Mellitus in 
the Sarawak State of Malaysia. 
The Ministry of Health Malaysia designs an education program for diabetes mellitus under the “Know Your 
Medicine” campaign. The program called  Pharmacy Integrated Community Care (PICC) hopes to improve 
knowledge and self-care for diabetes mellitus patients. PICC contains four modules that will provide 
knowledge on diabetes mellitus in an interactive, easy understand and fun program. We are interested in 
evaluating the effectiveness of the program in order to see its relevance to Malaysian. 
 
This information sheet gives you a detailed description of this study and will help you to decide if you 
would like to participate. Please read this sheet thoroughly and ask any questions that may occur to you. 
Participation in this research is voluntary. 
 
This study has been approved by the Medical Research and Ethics Committee of Malaysia.  
RESPONDENT COPY 

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Q1: What about this study? 
 
PICC is an education program to give knowledge on diabetes mellitus to the patients. It intended to improve 
self-care knowledge to patients with underlying Type 2 Diabetes Mellitus conducted to whole Malaysia. 
However, in Sarawak, we interested in conducting it together with this is an experimental study, which aims 
to examine the effectiveness of PICC. The study is being conducted in the nine Sarawak Division. A 
minimum of 94 respondents will be participating in this study. Your profile details will be taken with strict 
confidentiality.   
 
Q2: What will happen when you agree to participate? 
 
Your responsibility: 
1. We need you to fast at 10 pm the day before the program to take fasting blood glucose levels. The 
program will start at 8 am, with a health check-up, and breakfast will be provided. 
2. We need you to be punctual in order to run the program smoothly. You do not have to bring 
anything as all materials will be provided. 
 
Before the program: 
If you agree to take part in this study, the researcher will obtain written consent from you. After that, you 
will be invited to attend a program held at Health Clinic near your area from 1st May 2023 to 31st May 2023. 
You may choose the date that you prefer to attend, and you are acquired to present on the date that you had 
chosen. However, any change of your preference before the program must be informed to the investigators. 
Should there be a change or new information relevant to consent, we will inform you and request consent 
from you again. 
 
You will be "randomised" into one of the study groups described below. Randomisation means that you are 
put into a group by chance. A computer program will place you in one of the study groups, similar to 
flipping a coin.  Neither you nor your investigator can choose the group you will be in.  Only participants 
assigned to the intervention group will have to attend a program for four-session with free health check-ups 
for each session. Participants who are assigned to a controlled group will only have one session, with two 
free health check-up which is on the day of sign up and the day of the session. Free health check-ups consist 
of blood pressure, fasting blood glucose and HbA1C.   
During the program: 
On the day of the program, you will need to register yourself at the outpatient pharmacy department of the 
health clinic near you that we tell on the phone. After registration, you will be informed about the actual 
location of the program that you will attend. One of the locations will be the intervention group's venue, 
while the other one for the controlled group. Participants assigned to the intervention group will attend the 
PICC program, which will take four-month and each session 2.5 hours. Participants assigned to the 

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controlled group will have 2 hours lecture and spend approximately 30 minutes answering quizzes related 
to this study.  
During the program, we will introduce the content of the education module. You required to: 
1. To do basic health check-ups with us 
2. Participate in the light activity in the intervention group while in the control group to listen to a 
lecture. 
3. At the end of the program, a short written quiz is given. 
 
After the program: 
After four (4) months of the program finished, participants from both groups will be interviewed for 
approximately 5 minutes through phone call. 
During the interview, we ask: 
1. Your consent for the recorded interview 
2. To share your experience and comment freely will help to improve the program 
 
Q3: Are there any risks? 
 
The module of this study only consists of education that may involve light to minimal physical 
activities. The program is designed to engage the mind and, in the process, will ease the learning 
of diabetes mellitus knowledge. Since there is no clinical intervention or invasive procedure 
involved in this study, thus no risks to your health would arise.  
 
If you are injured by being in this study, treatment is available. Your insurance will be billed for 
the cost of treatment. The sponsor will pay for any necessary medical costs related to the treatment 
of your injury due to your taking part in the study and not paid by your insurance or any other 
payor. If you are injured, there is no money set aside for lost wages, discomfort, disability, etc. 
You do not give up your legal rights by signing this form. However, if you think you have a study-
related injury, please contact us, and we will assist. 
 
Q4: Are there any benefits? 
 
If you participate in this research, you will have the following benefits: the health check-up is free that 
consist of blood pressure, fasting blood glucose and HbA1C that we will share with the participants. There 
may not be any benefit for you, but your participation is likely to help find the answer to the research 
question.  There may not be any benefit to society at this stage of the research, but future generations are 
likely to benefit. 
The outcome of this study will be used to evaluate the effectiveness of the PICC in improving knowledge 
in self-care to apply the intervention to a larger population with underlying Type 2 Diabetes Mellitus. 
However, this study's results will not be informed to you individually as it only aimed to be translated into 
practical implications.  

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Q5: What if you do not want to participate, and when can you leave the study? 
Your participation in this study is voluntary, and it is entirely your decision. You can choose to leave the 
study at any time. Having agreed to participate and have signed the informed consent form, if you change 
your mind, your choice will be respected. However, you should inform the researcher about the reason 
behind your decision to withdraw. Those that are not consenting to participate as well as withdrawal of 
consent and with or without continuation of this program will not affect the medical services entitled.  
Q6: What if this study terminated? 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable cause. 
Written notification, documenting the reason for study suspension or termination, will be provided by the 
suspending or terminating party to the Investigator and Medical Research & Ethics Committee (MREC), 
Ministry of Health Malaysia, as appropriate.  If the study is prematurely terminated or suspended, the 
Investigator will promptly inform the MREC and provide the reason(s) for the termination or suspension. 
Circumstances that may warrant termination or suspension include, but are not limited to:  
• Determination of unexpected, significant, or unacceptable risk to participants  
• Demonstration of efficacy that would warrant stopping  
• Insufficient compliance to protocol requirements  
• Data that are not sufficiently complete and evaluable  
• Determination of futility  
The study may resume once concerns about safety, protocol compliance, data quality are addressed and 
satisfy the MREC. The sponsor may decide to terminate the study at any time. You will be informed if the 
study is terminated, and follow-up visits will be arranged if needed. 
Q7: What is the cost of the study? 
 
You do not need to pay and will not be paid for taking part in this study. This study is sponsored by 
Pharmaceutical Service Division, Sarawak State Health Department.   
Q8: Will the information and your identity remain confidential? 
 
The information that we collect from this research project will be kept confidential. Information 
about you collected during the research will be put away, and no one but the researchers will see 
it. Any information about you will have a number on it instead of your name. Only the researchers 
will know what your number is, and we will lock that information up with a lock and key. It will 
not be shared with or given to anyone except by the study investigators of the Pharmaceutical 
Service Division, Sarawak State Health Department. On completion of the study, data in the 
computer will be copied to CDs, and the data in the computer will be erased. The CDs is password-
protected, and any hardcopy data will be stored in a locked office of the investigators and 
maintained for a minimum of three years after completing the study. The CDs and data will be 
destroyed after that period of storage. The confidentiality of your identification and information 
will always be protected. Your identification and information will not be used for other purposes 
or by other parties without your consent.   

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All the results of this study will be treated in complete confidence to the extent permitted by law. 
All the data are restricted to the principal investigators and solely used for research purposes and 
publication. The participant will be informed after the data is published. 
 
 
 Q9: How will my data be used? 
 
All your information obtained in this study will be kept and handled confidentially, under 
applicable laws and regulations. When publishing or presenting the study results, your identity will 
not be revealed without your expressed consent. Individuals involved in this study and your 
medical care, qualified monitors and auditors, the sponsor or its affiliates and governmental or 
regulatory authorities may inspect your medical records and study data where appropriate and 
necessary 
\Q10: What if you have more questions or do not understand something? 
If you have any questions about the study or if you think you have a study-related injury and you want 
information about this study, please contact : 
Mr Kamarudin Bin Ahmad  
at 0128789869 or kamarudin_a@moh.gov.my  
 
If you have any questions about your rights as a participant in this study, please contact The Secretary, 
Medical Research & Ethics Committee, Ministry of Health Malaysia, at telephone number 03-3362 
8407/8205/8888. 
 
 
 
 
 
 
 
 
 
 

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INFORMED CONSENT FORM 
 
 
STUDY TITLE 
Effectiveness of Pharmacy Integrated Community Care (PICC) improving Hemoglobin A1c (HBA1C) and 
Knowledge in diabetes mellitus (DM) education program  
 
(Protocol Number: 958       7) 
 
 
 
 
 
 
 
 
 
 
_______________ 
 
CERTIFICATION BY INVESTIGATOR 
I, being the researcher, confirm that I have fully explained the nature, purpose and reasonably 
foreseeable risks of taking part in this study to the participants or legal representative. He/she has 
read and kept a copy of the Information Sheet and signed the Informed Consent Form. He/she 
has freely agreed to participate in the study.  
 
Signature: 
 
I.C number: 
 
 
 
 
 
Name: 
 
Date: 
 
 
 
 
 
 
 
 
 
 
 
_______________ 
 
CONSENT BY PARTICIPANT 
I have read and understood the Information Sheet about this research and have been given a 
chance to ask any questions. I understand and accept the answers that have been given.  
 
I confirm that I have been given enough time to think about and have freely agreed to take part in 
this research and know that I can at any time, ask for more information from the pharmacist and 
doctor, and cease to participate in the research without affecting my health status in any way.  
 
I also understand that should I decide to stop taking part in this study, I do not need to explain 
why. In this case, I must report the details to the pharmacist. 
 
          PARTICIPANT COPY 

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Finally, I agree to participate in the research and to follow the instructions I am given closely.   I 
have received a copy of the Information Sheet and Informed Consent Form. 
 
 
Signature: 
 
I.C number: 
 
 
 
 
 
Name: 
 
Date: 
 
 
 
 
 
 
 
 
 
 
 
______________ 
 
IF REQUIRED IMPARTIAL WITNESS 
 
 
Signature: 
 
I.C number: 
 
 
 
 
 
Name: 
 
Date: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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INFORMED CONSENT FORM 
 
FACILITY COPY 
STUDY TITLE 
Effectiveness of Pharmacy Integrated Community Care (PICC) improving Hemoglobin A1c (HBA1C) and 
Knowledge in diabetes mellitus (DM) education program  
 
(Protocol Number: 958       7) 
 
 
 
 
 
 
 
 
 
 
_______________ 
 
CERTIFICATION BY INVESTIGATOR 
I, being the researcher, confirm that I have fully explained the nature, purpose and reasonably 
foreseeable risks of taking part in this study to the participants or legal representative. He/she has 
read and kept a copy of the Information Sheet and signed the Informed Consent Form. He/she 
has freely agreed to participate in the study.  
 
Signature: 
 
I.C number: 
 
 
 
 
 
Name: 
 
Date: 
 
 
 
 
 
 
 
 
 
 
 
_______________ 
 
CONSENT BY PARTICIPANT 
I have read and understood the Information Sheet about this research and have been given a 
chance to ask any questions. I understand and accept the answers that have been given.  
 
I confirm that I have been given enough time to think about and have freely agreed to take part in 
this research and know that I can at any time, ask for more information from the pharmacist and 
doctor, and cease to participate in the research without affecting my health status in any way.  
 
I also understand that should I decide to stop taking part in this study, I do not need to explain 
why. In this case, I must report the details to the pharmacist. 
 

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Finally, I agree to participate in the research and to follow the instructions I am given closely.   I 
have received a copy of the Information Sheet and Informed Consent Form. 
 
 
Signature: 
 
I.C number: 
 
 
 
 
 
Name: 
 
Date: 
 
 
 
 
 
 
 
 
 
 
 
______________ 
 
IF REQUIRED IMPARTIAL WITNESS 
 
 
Signature: 
 
I.C number: 
 
 
 
 
 
Name: 
 
Date: