Clinical trial NCT02105597: A Smartphone Application to Improve Medication Adherence Among People With Type 2 Diabetes Mellitus in Singapore
Official title: A Smartphone Application to Improve Medication Adherence Among People With Type 2 Diabetes Mellitus in Singapore: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes mellitus
Medication adherence
Compliance
Mobile health
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: National University of Singapore
First posted: 2014-04-07
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Existing Type 2 DM managed at SGH Diabetes Centre and those referred to the pharmacist-led MTM service
* 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 manage own medications (e.g. taken care of by caregiver, nursing home patients, cognitive impairment)
* Unable to read and comprehend English
* Physical impairment that precludes the use of smart phone functions (e.g. deformed finger joints, amputation)

Primary outcomes:
measure: Change in self-reported medication adherence
timeFrame: Baseline (at recruitment) and 6 months (+/- 4 weeks)
Secondary outcomes:
measure: Change in HbA1c
timeFrame: Baseline (at recruitment) and 6 months (+/- 4 weeks)
measure: Change in blood glucose
timeFrame: Baseline (at recruitment) and 6 months (+/- 4 weeks)
measure: Frequency of dose titrations of oral hypoglycemic agents and insulin
timeFrame: 6 months (+/- 4 weeks) after recruitment
measure: Addition or removal of oral hypoglycemic agents and insulin
timeFrame: 6 months (+/- 4 weeks) after recruitment
measure: Change in health-related quality of life
timeFrame: Baseline (at recruitment) and 6 months (+/- 4 weeks)
measure: Change in health status
timeFrame: Baseline (at recruitment) and 6 months (+/- 4 weeks)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Hua Heng McVin Cheen, B.Sc (Pharm)
role: PRINCIPAL_INVESTIGATOR
References: