A Smartphone Application to Improve Medication Adherence Among People With Type 2 Diabetes Mellitus in Singapore

Diabetes Mellitus Clinical Trial

— iADHERE  

Official title:

A Smartphone Application to Improve Medication Adherence Among People With Type 2 Diabetes Mellitus in Singapore: A Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02105597
• Other study ID #: iADHERE-01
• Status: Withdrawn
• Phase: N/A
• First received: March 28, 2014
• Last updated: February 9, 2017
• Start date: August 2014

Study information

• Verified date: February 2017
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• Mobile application
The intervention in this study is a mobile application which will be downloaded into the participant's smartphone.

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Singapore General Hospital	National University, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in self-reported medication adherence	Self-reported medication adherence will be assessed using the 8-item Morisky Medication Adherence Scale.	Baseline (at recruitment) and 6 months (+/- 4 weeks)
Secondary	Change in HbA1c	Part of routine monitoring during doctor's appointment	Baseline (at recruitment) and 6 months (+/- 4 weeks)
Secondary	Change in blood glucose	Part of routine monitoring during doctor's appointment	Baseline (at recruitment) and 6 months (+/- 4 weeks)
Secondary	Frequency of dose titrations of oral hypoglycemic agents and insulin		6 months (+/- 4 weeks) after recruitment
Secondary	Addition or removal of oral hypoglycemic agents and insulin		6 months (+/- 4 weeks) after recruitment
Secondary	Change in health-related quality of life	Measured using Audit of Diabetes Dependent Quality of Life - 19 (ADDQoL-19) questionnaire	Baseline (at recruitment) and 6 months (+/- 4 weeks)
Secondary	Change in health status	Measured using EuroQol-5D-5L and EuroQol Visual Analogue Scale.	Baseline (at recruitment) and 6 months (+/- 4 weeks)