A Smartphone Application to Improve Medication Adherence Among People With Type 2 Diabetes Mellitus in Singapore
NCT ID: NCT02105597
Last Updated: 2017-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2014-08-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Mobile application
Mobile application
The intervention in this study is a mobile application which will be downloaded into the participant's smartphone.
Standard care
No interventions assigned to this group
Interventions
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Mobile application
The intervention in this study is a mobile application which will be downloaded into the participant's smartphone.
Eligibility Criteria
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Inclusion Criteria
* Age≥ 40 years
* HbA1c≥ 8.0
* Suspected non-adherence (e.g. admitted to have missed doses, HbA1c not at target despite frequent dose titrations, recent DM related hospitalization/ emergency visit)
* Owns a iOS smartphone with Wi-Fi or data plan
Exclusion Criteria
* Unable to read and comprehend English
* Physical impairment that precludes the use of smart phone functions (e.g. deformed finger joints, amputation)
40 Years
ALL
No
Sponsors
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National University of Singapore
OTHER
Singapore General Hospital
OTHER
Responsible Party
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Principal Investigators
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Hua Heng McVin Cheen, B.Sc (Pharm)
Role: PRINCIPAL_INVESTIGATOR
Singapore General Hospital
Locations
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Singapore General Hospital
Singapore, , Singapore
Countries
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Other Identifiers
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iADHERE-01
Identifier Type: -
Identifier Source: org_study_id
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