NCT03228706: MedAdh-RCT

Effectiveness of an Intervention in Improving Medication Adherence Among Malay Patients With Underlying Type 2 Diabetes Mellitus in Malaysia

Completed NA Last updated 26 March 2020

What this trial tests

NA trial testing Know Your Medicine - Take It For Health (KYM-TIFH) in Medication Adherence in 142 participants. Completed in 30 June 2019.

Timeline

1 August 2017

Primary endpoint
30 June 2019

30 June 2019

Quick facts

Lead sponsor	Clinical Research Centre, Malaysia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	other
Enrollment	142
Start date	1 August 2017
Primary completion	30 June 2019
Estimated completion	30 June 2019
Sites	2 locations across Malaysia

Drugs / interventions tested

• Know Your Medicine - Take It For Health (KYM-TIFH)

Conditions studied

• Medication Adherence — all drugs for Medication Adherence →
• Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →

Sponsor

Clinical Research Centre, Malaysia

Who can join

18 and older, any sex, with Medication Adherence or Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effectiveness and sustainability of a structured group-based educational program (MEDIHEALTH) in improving medication adherence among Malay patients with underlying type 2 diabetes mellitus in Sarawak State of Malaysia: study protocol of a randomized controlled trial.
   Ting CY, Ahmad Zaidi Adruce S, Hassali MA, Ting H, et al · · 2018 · cited 6× · PMID 29871651 · DOI 10.1186/s13063-018-2649-9