Diabetes Mellitus Clinical Trial
Official title:
A Smartphone Application to Improve Medication Adherence Among People With Type 2 Diabetes Mellitus in Singapore: A Randomized Controlled Trial
Background: Diabetes mellitus (DM) is a major cause of morbidity and mortality worldwide.
Long-term glycemic control is important to prevent or delay the onset of DM related
complications. Patients often fail to achieve optimal glycemic control from pharmacotherapy
due to non-adherence. With the high prevalence of smartphone usage locally and among the
developed countries, there has been a growing interest to deliver interventions through
mobile applications. In this study, a mobile application targeted at improving medication
adherence among people with Type 2 DM will be developed and evaluated.
Aims: This study aims to (i) design a smartphone application to improve medication adherence
and (ii) evaluate its impact on clinical outcomes, health-related quality of life (HRQoL)
and health status among patients with Type 2 DM.
Hypothesis: The use of a smartphone application can improve medication adherence among
patients with Type 2 DM, as well as clinical outcomes, HRQoL and health status.
Methods: This is a randomized, open-label controlled trial involving patients with Type 2 DM
managed at Singapore General Hospital. Patients seen at the institution's Diabetes Centre
and those referred to the pharmacist-led Medication Therapy Management service are eligible
to participate. Patients in the intervention group will have the mobile application
downloaded onto their smartphones, while those in the control group will receive the usual
standard of care. The primary outcome will be change in self-reported medication adherence,
determined using the 8-item Morisky Medication Adherence Scale. Secondary outcomes include
change in HbA1c, blood glucose, frequency of dose titrations, addition or removal of oral
hypoglycemic agents, HRQoL (measured using the Audit of Diabetes Dependent Quality of Life)
and health status (measured using the EuroQol-5D-5L and EuroQol Visual Analogue Scale). All
outcomes will be measured at baseline and at the end of the 6-month study period (± 4
weeks).
Significance: The development and evaluation of a mobile application to improve adherence
among patients with Type 2 DM in Singapore is the first of its kind, and the findings of
this study will provide the much-needed evidence to demonstrate the effectiveness of this
intervention.
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