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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

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

Authors: Chuo Yew Ting, Shahren Ahmad Zaidi Adruce, Mohamed Azmi Hassali, Hiram Ting, Chien Joo Lim, Rachel Sing-Kiat Ting, Abu Hassan Alshaari Abd Jabar, Nor Anizah Osman, Izzul Syazwan Shuib, Shing Chyi Loo, Sui Theng Sim, Su Ee Lim, Donald E. Morisky

Published in: Trials | Issue 1/2018

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Abstract

Background

Amidst the high disease burden, non-adherence to medications among patients with type 2 diabetes mellitus (T2DM) has been reported to be common and devastating. Sarawak Pharmaceutical Services Division has formulated a pharmacist-led, multiple-theoretical-grounding, culturally sensitive and structured group-based program, namely “Know Your Medicine – Take if for Health” (MEDIHEALTH), to improve medication adherence among Malay patients with T2DM. However, to date, little is known about the effectiveness and sustainability of the Program.

Methods/design

This is a prospective, parallel-design, two-treatment-group randomized controlled trial to evaluate the effectiveness and sustainability of MEDIHEALTH in improving medication adherence. Malay patients who have underlying T2DM, who obtain medication therapy at Petra Jaya Health Clinic and Kota Samarahan Health Clinic, and who have a moderate to low adherence level (8-item Morisky Medication Adherence Scale, Malaysian specific, score <6) were randomly assigned to the treatment group (MEDIHEALTH) or the control group. The primary outcome of this study is medication adherence level at baseline and 1, 3, 6 and 12 months post-intervention. The secondary outcomes are attitude, subjective norms, perceived behavioural control, intention and knowledge related to medication adherence measured at baseline and 1, 6 and 12 months post-intervention. The effectiveness and sustainability of the Program will be triangulated by findings from semi-structured interviews with five selected participants conducted 1 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. Statistical analyses of quantitative data were conducted using SPSS version 22 and Stata version 14. Thematic analysis for qualitative data were conducted with the assistance of ATLAS.ti 8.

Discussion

This study provides evidence on the effectiveness and sustainability of a structured group-based educational program that employs multiple theoretical grounding and a culturally sensitive approach in promoting medication adherence among Malays with underlying T2DM. Both the quantitative and qualitative findings of this study could assist in the future development of the Program.

Trial registration

National Medical Research Register, NMRR-17-925-35875 (IIR). Registered on 19 May 2017. ClinicalTrials.gov, NCT03228706. Registered on 25 July 2017.
Appendix
Available only for authorised users
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Metadata
Title
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
Authors
Chuo Yew Ting
Shahren Ahmad Zaidi Adruce
Mohamed Azmi Hassali
Hiram Ting
Chien Joo Lim
Rachel Sing-Kiat Ting
Abu Hassan Alshaari Abd Jabar
Nor Anizah Osman
Izzul Syazwan Shuib
Shing Chyi Loo
Sui Theng Sim
Su Ee Lim
Donald E. Morisky
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2649-9

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