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

Primary Purpose

Diabetes Mellitus

Status
Withdrawn
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Mobile application
Sponsored by
Singapore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus focused on measuring Diabetes mellitus, Medication adherence, Compliance, Mobile health

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Singapore General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mobile application

Standard care

Arm Description

Outcomes

Primary Outcome Measures

Change in self-reported medication adherence
Self-reported medication adherence will be assessed using the 8-item Morisky Medication Adherence Scale.

Secondary Outcome Measures

Change in HbA1c
Part of routine monitoring during doctor's appointment
Change in blood glucose
Part of routine monitoring during doctor's appointment
Frequency of dose titrations of oral hypoglycemic agents and insulin
Addition or removal of oral hypoglycemic agents and insulin
Change in health-related quality of life
Measured using Audit of Diabetes Dependent Quality of Life - 19 (ADDQoL-19) questionnaire
Change in health status
Measured using EuroQol-5D-5L and EuroQol Visual Analogue Scale.

Full Information

First Posted
March 28, 2014
Last Updated
February 9, 2017
Sponsor
Singapore General Hospital
Collaborators
National University of Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT02105597
Brief Title
A Smartphone Application to Improve Medication Adherence Among People With Type 2 Diabetes Mellitus in Singapore
Acronym
iADHERE
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Poor patient recruitment
Study Start Date
August 2014 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
Collaborators
National University of Singapore

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
Keywords
Diabetes mellitus, Medication adherence, Compliance, Mobile health

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile application
Arm Type
Experimental
Arm Title
Standard care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Mobile application
Intervention Description
The intervention in this study is a mobile application which will be downloaded into the participant's smartphone.
Primary Outcome Measure Information:
Title
Change in self-reported medication adherence
Description
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)
Secondary Outcome Measure Information:
Title
Change in HbA1c
Description
Part of routine monitoring during doctor's appointment
Time Frame
Baseline (at recruitment) and 6 months (+/- 4 weeks)
Title
Change in blood glucose
Description
Part of routine monitoring during doctor's appointment
Time Frame
Baseline (at recruitment) and 6 months (+/- 4 weeks)
Title
Frequency of dose titrations of oral hypoglycemic agents and insulin
Time Frame
6 months (+/- 4 weeks) after recruitment
Title
Addition or removal of oral hypoglycemic agents and insulin
Time Frame
6 months (+/- 4 weeks) after recruitment
Title
Change in health-related quality of life
Description
Measured using Audit of Diabetes Dependent Quality of Life - 19 (ADDQoL-19) questionnaire
Time Frame
Baseline (at recruitment) and 6 months (+/- 4 weeks)
Title
Change in health status
Description
Measured using EuroQol-5D-5L and EuroQol Visual Analogue Scale.
Time Frame
Baseline (at recruitment) and 6 months (+/- 4 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hua Heng McVin Cheen, B.Sc (Pharm)
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore

12. IPD Sharing Statement

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

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