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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Change of HbA1c level at baseline, and at 3, 6 and 12 months after intervention.
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
A person who is independent of this study and invited by principal investigator will carry out the randomization based on the list of participants who are eligible and agreed to participate. The list of participants with their randomization information will be kept by the committee member without informing any of the researchers including principal investigator or respondents to assure the blinding of both parties throughout the study. On the day of the intervention, that person will register the attendance of respondents and inform them about the actual venue of the program without informing the researchers or the facilitators of the KYM-TIFH. Each HCKS and HCKS will have two venues prepared and available during the period of the study with one venue allocated for intervention group and the other one with for control group. None of the respondents were aware of the difference between the with assigned.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HbA1c > 7 %
- •Malay T2DM patients > 18 years old
- •Poor medication adherence (self-efficacy for appropriate medication use scale scoring < 26)
排除标准
- •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
研究组 & 干预措施
Intervention Group
All the participants who are randomly assigned to the intervention group will be undergoing the Know Your Medicine-Take it for Health (KYM-TIFH) program, which is a one-off structured group-based intervention (SGBI).
干预措施: Know Your Medicine - Take It For Health (KYM-TIFH) (Behavioral)
Control Group
All the participants who are randomly assigned to the control group will not be given any information related to KYM-TIFH. However, they will be assigned to the venue for the control group and will be asked to fill in questionnaires with the assistance of four facilitators. A briefing on how to answer the questionnaire will be given by the main facilitator and all facilitators are allowed to answer any questions raised by respondents related to the questionnaire. However, they are not allowed to answer on behalf of the respondents. After the completion of the questionnaire, they will be informed about the subsequent follow-up measurement after three, six and twelve months. After that, they will be dismissed and having usual care provided by the health clinic as before without any changes.
结局指标
主要结局
Change of HbA1c level at baseline, and at 3, 6 and 12 months after intervention.
时间窗: Measured during the recruitment of participants and after 3, 6 and 12 months of the intervention.
The HbA1c level before the intervention and after three, six and twelve months of the intervention.
Change of medication adherence at baseline, and at 3, 6 and 12 months after intervention.
时间窗: 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
The medication adherence is measured by self-efficacy for appropriate medication use scale (Risser et al., 2007).
次要结局
- Change of intention to adhere at baseline, and at 3, 6 and 12 months after intervention.(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)
- Change of adherence information at baseline, and at 3, 6 and 12 months after intervention.(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)
- Change of attitude towards medication adherence at baseline, and at 3, 6 and 12 months after intervention.(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)
- Change of subjective norms towards medication adherence at baseline, and at 3, 6 and 12 months after intervention.(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)
- Change of perceived behavioural control towards medication adherence at baseline, and at 3, 6 and 12 months after intervention.(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)
研究者
Ting Chuo Yew
Principal Assistant Director (Pharmacy Enforcement)
Clinical Research Centre, Malaysia