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

February 9, 2017 updated by: Singapore General Hospital

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Singapore, Singapore, 169608
        • Singapore General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard care
Experimental: Mobile application
The intervention in this study is a mobile application which will be downloaded into the participant's smartphone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self-reported medication adherence
Time Frame: Baseline (at recruitment) and 6 months (+/- 4 weeks)
Self-reported medication adherence will be assessed using the 8-item Morisky Medication Adherence Scale.
Baseline (at recruitment) and 6 months (+/- 4 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c
Time Frame: Baseline (at recruitment) and 6 months (+/- 4 weeks)
Part of routine monitoring during doctor's appointment
Baseline (at recruitment) and 6 months (+/- 4 weeks)
Change in blood glucose
Time Frame: Baseline (at recruitment) and 6 months (+/- 4 weeks)
Part of routine monitoring during doctor's appointment
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
6 months (+/- 4 weeks) after recruitment
Addition or removal of oral hypoglycemic agents and insulin
Time Frame: 6 months (+/- 4 weeks) after recruitment
6 months (+/- 4 weeks) after recruitment
Change in health-related quality of life
Time Frame: Baseline (at recruitment) and 6 months (+/- 4 weeks)
Measured using Audit of Diabetes Dependent Quality of Life - 19 (ADDQoL-19) questionnaire
Baseline (at recruitment) and 6 months (+/- 4 weeks)
Change in health status
Time Frame: Baseline (at recruitment) and 6 months (+/- 4 weeks)
Measured using EuroQol-5D-5L and EuroQol Visual Analogue Scale.
Baseline (at recruitment) and 6 months (+/- 4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hua Heng McVin Cheen, B.Sc (Pharm), Singapore General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

March 28, 2014

First Submitted That Met QC Criteria

April 2, 2014

First Posted (Estimate)

April 7, 2014

Study Record Updates

Last Update Posted (Actual)

February 10, 2017

Last Update Submitted That Met QC Criteria

February 9, 2017

Last Verified

February 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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