Clinical trial NCT03228706: Effectiveness of an Intervention in Improving Medication Adherence Among Malay Patients With Underlying Type 2 Diabetes Mellitus in Malaysia
Official title: Effectiveness of a Structured Group-Based Intervention "Know Your Medicine - Take It For Health" (KYM-TIFH) in Improving Medication Adherence Among Malay Patients With Underlying Type 2 Diabetes Mellitus in the Sarawak State of Malaysia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Medication Adherence
Malay patients
Structured Group-Based Intervention
Randomised controlled trial
Lead sponsor: Clinical Research Centre, Malaysia
Sponsor class: OTHER
Collaborators: name: University Malaysia Sarawak
First posted: 2017-07-25
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To achieve the objectives, positivist approach with experimental study design will be employed. In specific, it is a double blinded, randomized controlled trial (RCT) which involve two study sites. Nonetheless, the reporting of the SGBI will be in accordance with the checklist recommended by Borek et al. (2015).
Primary purpose: OTHER

Brief summary: Poor medication adherence (MA) among Type 2 Diabetes Mellitus (T2DM) patients had found to be gnarly and devastating (Krass et al 2015; Sharma et al 2014). It was estimated that more than half of the patients failed to achieve recommended glycaemic goals due to nonadherence (García-Pérez 2013; World Health Organization 2003). Furthermore, greater adherence rate was significantly associated with better glycemic control, fewer hospital visits and admissions, and lower medical costs. On the other hand, lower adherence rate was significantly associated with poor medication tolerance, the frequency of medication intake (\> 2 times a day), having concomitant depression and negative belief about the medications. Consequently, patients who poorly adhere to medications would take more medications due to the poor glycemic control and development of micro- and macrovascular complications (American Diabetes Association 2013). Such condition would further worsen their adherence due to more complex medications and a greater chance of experiencing drug-related side effects (García-Pérez 2013). This inevitably increases the economic burden and wastage to the healthcare system (Meng et al 2017). Hence breaking the vicious cycle is an urgent call to all stakeholders.

Notably, Ministry of Health Malaysia (MOH) had initiated several interventions in curbing the MA problems at national level. One of those which has been perpetuated and led by pharmacists is "Know Your Medicine" (KYM) Campaign since 2007. The national KYM campaign aims to promote the quality use of medicines through mass communication and group-based approach. The messages conveyed include information on their medication management such as why, how and when to take medicines, reporting adverse drug events, awareness on the rational use of medicines and medications that need special precautions. In specific, assuring and improving medication adherence among patients is one of the important components of the campaign (PSD 2008).

In term of improving medication adherence among Malay T2DM patients, a structured group-based intervention (SGBI) called "Know Your Medicine - Take It For Health" with abbreviation KYM-TIGF, was created by the researchers of this study who work at Sarawak Pharmaceutical Services Division in 2016 under the KYM campaign. The KYM-TIGF is a theoretical based, patient empowerment, culturally appropriate and a combination of psychosocial, educational and behavioral intervention. It is a one-off SGBI that aims to improve the medication adherence through the message specially designed with a cross-theoretical framework as recommended by Slater (1999). The model to measure the effectiveness of the SGBI is an integrated model with Theory of Planned Behaviour (Ajzen 1991) as main theory and Information-Motivation-Behavioural Skills Model (Fisher et al. 2006) as supporting theory. The primary outcome of this study is the HbA1c. The secondary outcomes of this study are the medication adherence level as well as the psychosocial variables of the integrated model which include attitude to medication adhere, the subjective norm to medication adherence, perceived behavioral control towards medication adherence, adherence information, adherence skill and intention to adhere.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* HbA1c \> 7 %
* Malay T2DM patients \> 18 years old
* Poor medication adherence (self-efficacy for appropriate medication use scale scoring \< 26)

Exclusion Criteria:

* Pregnant Women
* Patients less than 18 years old
* Patients who had severe and enduring mental health problems
* Patients who can't listen or read due to inherited disabilities or malfunction
* Patients who unable to communicate in the Malay language
* Patients who are participating in other studies
* Patients who decline the consent to participate
* Hospitalized

Primary outcomes:
measure: Change of HbA1c level at baseline, and at 3, 6 and 12 months after intervention.
timeFrame: Measured during the recruitment of participants and after 3, 6 and 12 months of the intervention.
measure: Change of medication adherence at baseline, and at 3, 6 and 12 months after intervention.
timeFrame: Intervention group: measured right before and 3,6 and 12 months after the program. Control group: measured measured right before and 3,6 and 12 months after the program
Secondary outcomes:
measure: Change of adherence information at baseline, and at 3, 6 and 12 months after intervention.
timeFrame: Intervention group: measured right before and 3,6 and 12 months after the program. Control group: measured measured right before and 3,6 and 12 months after the program
measure: Change of attitude towards medication adherence at baseline, and at 3, 6 and 12 months after intervention.
timeFrame: Intervention group: measured right before and 3,6 and 12 months after the program. Control group: measured measured right before and 3,6 and 12 months after the program
measure: Change of subjective norms towards medication adherence at baseline, and at 3, 6 and 12 months after intervention.
timeFrame: Intervention group: measured right before and 3,6 and 12 months after the program. Control group: measured measured right before and 3,6 and 12 months after the program
measure: Change of perceived behavioural control towards medication adherence at baseline, and at 3, 6 and 12 months after intervention.
timeFrame: Intervention group: measured right before and 3,6 and 12 months after the program. Control group: measured measured right before and 3,6 and 12 months after the program
measure: Change of intention to adhere at baseline, and at 3, 6 and 12 months after intervention.
timeFrame: Intervention group: measured right before and 3,6 and 12 months after the program. Control group: measured measured right before and 3,6 and 12 months after the program
Other outcomes:
measure: Qualitative evaluation on the effectiveness of the program
timeFrame: The selected participants will be interviewed upon 1 month after the program
measure: Sustainability of the Program
timeFrame: Two main facilitators and the two managerial officers will be interviewed at 12 months after the program
Locations:
city: Kota Samarahan
country: Malaysia
facility: Kota Samarahan Health Clinic
state: Sarawak
city: Kuching
country: Malaysia
facility: Petra Jaya Health Clinic
state: Sarawak
Study officials:
affiliation: Sarawak Pharmacy Enforcement Division, Sarawak State Health Department
name: Ting Chuo Yew, MPhil
role: PRINCIPAL_INVESTIGATOR
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