An interventional study of Mobile application in Diabetes Mellitus, sponsored by Singapore General Hospital. Withdrawn at 1 site in Singapore. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2017-02-10.
Sponsored by Singapore General Hospital · Not applicable, Interventional, and Health services research
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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Exclusion Criteria:
Other: Mobile application
The intervention in this study is a mobile application which will be downloaded into the participant's smartphone.
Change in self-reported medication adherence
Self-reported medication adherence will be assessed using the 8-item Morisky Medication Adherence Scale.
Time frame: Baseline (at recruitment) and 6 months (+/- 4 weeks)
Change in HbA1c
Part of routine monitoring during doctor's appointment
Time frame: Baseline (at recruitment) and 6 months (+/- 4 weeks)
Change in blood glucose
Part of routine monitoring during doctor's appointment
Time frame: Baseline (at recruitment) and 6 months (+/- 4 weeks)
Frequency of dose titrations of oral hypoglycemic agents and insulin
Time frame: 6 months (+/- 4 weeks) after recruitment
Addition or removal of oral hypoglycemic agents and insulin
Time frame: 6 months (+/- 4 weeks) after recruitment
Change in health-related quality of life
Measured using Audit of Diabetes Dependent Quality of Life - 19 (ADDQoL-19) questionnaire
Time frame: Baseline (at recruitment) and 6 months (+/- 4 weeks)
Change in health status
Measured using EuroQol-5D-5L and EuroQol Visual Analogue Scale.
Time frame: Baseline (at recruitment) and 6 months (+/- 4 weeks)
This study is withdrawn, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Singapore General Hospital