A current systematic review by Odgers-Jewell et al (2017) revealed that little had been done to investigate the effectiveness of group based education in improving medication adherence among T2DM patients. This concur with the comprehensive review on interventions to improve medication adherence by Conn \& Ruppar (2017), as the researchers conclude that there is an urgent need in evaluating the interventions to improve medication adherence that employs group-based approach.
The evidence on the effectiveness of the KYM-TIFH in promoting medication adherence among T2DM patients remain lacking. Furthermore, the current measurement on the effectiveness of the campaign is the increment of the awareness level of public towards proper use of medicines (PSD 2013) without measuring the impact of the campaign on actual behavior change.
Besides aforementioned, Malay ethnic was found to be the main contributor to the prevalence of poor MA (PSD 2013) due to forgetfulness (75.3%) and reluctant to take prescribed medications (43.8%). Facing the high prevalence of poor MA among Malay patients, an effective and efficient approach which could engage more patients within a shorter period of times to improve the medication adherence problems is highly preferred (Odgers-Jewell 2017). Hence, all the problem statements addressed above lead to the necessity of conducting this study, which aims to investigate the effectiveness of the SGBI "KYM-TIFH" in improving MA among Malay patients with T2DM.
Based on the problems stated above, this study aims (1) to measure the effectiveness of MEDIHEALTH in improving the medication adherence level and the component of the extended TPB, (2) to identify the component of the extended TPB that predicts medication adherence after participating in MEDIHEALTH, and (3) to investigate the sustainability of the program.
Based on the first specific objective, ten hypotheses are to be tested:
H1a: Increase in intention to adhere would be mediated by improvements in attitude towards adherence after baseline, which is achieved by participating in MEDIHEALTH.
H1b: Increase in intention to adhere would be mediated by improvements in subjective norm towards adherence after baseline, which is achieved by participating in MEDIHEALTH.
H1c: Increase in medication adherence would be mediated by improvements in intention to adhere after baseline, which is achieved by participating in MEDIHEALTH.
H1d: Increase in intention to adhere would be mediated by improvements in perceived behavioural control towards adherence after baseline, which is achieved by participating in MEDIHEALTH.
H1e: Increase in intention to adhere would be mediated by improvements in adherence information after baseline, which is achieved by participating in MEDIHEALTH.
H1f: Before the intervention, there are no significant differences of medication adherence level and the psychosocial variables related to it among the participants between the intervention group and the control group.
H1g: After 3, 6 and 12 months of the program, the medication adherence levels among the participants in the intervention group are significantly greater than the medication adherence levels before the intervention.
H1h: After 3, 6 and 12 months of the program, the medication adherence levels among the participants in the intervention group are significantly greater than the medication adherence levels of the participants in the control group.
H1i: After 3, 6 and 12 months of the program, the HbA1c levels among the participants in the intervention group are significantly greater than the HbA1c before the intervention.
H1j: After 3, 6 and 12 months of the program, the HbA1c levels among the participants in the intervention group are significantly greater than the HbA1c levels of the participants in the control group.
For the second specific objective, eight hypotheses are to be tested:
H2a: Improvement in attitude towards adherence will contribute to the increase in intention to adhere.
H2b: Improvement in subjective norm towards adherence will contribute to the increase in intention to adhere.
H2c: Improvement in perceived behavioural control towards adherence will contribute to the increase in intention to adhere.
H2d: Improvement in perceived behavioural control towards adherence will contribute to the increase in medication adherence.
H2e: Improvement in intention to adhere will contribute to the increase in medication adherence.
H2f: Improvement in adherence information will contribute to the increase in perceived behavioural control towards adherence.
H2g: Improvement in adherence information will contribute to the increase in medication adherence.
H2i: Improvement in medication adherence level will contribute to the decrease in HbA1c level.
Operational definitions:
1. Medication adherence: Medication adherence is defined as the level of patients in complying with the medications prescribed by healthcare providers. Such level of compliance is measured through 13 items self-efficacy for appropriate medication use scale (Risser et al., 2007) which had been validated among chronic patients with low literacy.
2. T2DM Malay patients: Type 2 Diabetes Mellitus Malay patients of this study refers to all the patients who are prescribed with oral anti-hyperglycaemic agents (OHA) and obtain their medications supply from the pharmacy department of Kota Samarahan Health Clinic (KS-HC) and Petra Jaya Health Clinic (PJ-HC) during the study period. Such T2DM patients whose identity card show their religion as Islam, will be considered as Malay T2DM patients for this study.
3. Structured group based intervention: The structured group based intervention of this study refers to the program "Know Your Medicine - Take it for Health" which was formulated and employed by the Pharmaceutical Services Division of Sarawak State Health Department in late 2016 under the national campaign "Know Your Medicine" to promote medication adherence among T2DM Malay patients. The official name of the intervention is "Kenali Ubat Anda - Ambillah untuk Kesihatan" in Malay language or "Know Your Medicine - Take it for Health" in English with abbreviation KYM-TIFH.
4. Effectiveness: The effectiveness of this study refers to the improvement of HbA1c and medication adherence level among T2DM Malay patients before and after the SGBI with such improvement having a significant difference as compared to the results in control group. Furthermore, the effectiveness of the SGBI will be complemented by the qualitative data through focus group discussion and a semi-structured interview.
5. Complications: The complications in this study refers to the diabetes-related complications including retinopathy, nephropathy, diabetic foot problems, ischemic heart disease and stroke that had been diagnosed by doctors and were documented in patients' medical records during the period of study.