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

NCT02105597 | Withdrawn

• 1 other identifier: iADHERE-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

Diabetes mellitus; Medication adherence; Compliance; Mobile health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in HbA1c

  Baseline (at recruitment) and 6 months (+/- 4 weeks)

• Change in blood glucose

  Baseline (at recruitment) and 6 months (+/- 4 weeks)

• Frequency of dose titrations of oral hypoglycemic agents and insulin

  6 months (+/- 4 weeks) after recruitment

• Addition or removal of oral hypoglycemic agents and insulin

  6 months (+/- 4 weeks) after recruitment

• Change in health-related quality of life

  Baseline (at recruitment) and 6 months (+/- 4 weeks)

Study Arms (2)

Mobile application

EXPERIMENTAL

Other: Mobile application

Standard care

NO INTERVENTION

Interventions

Mobile application OTHER

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

Mobile application

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Singapore General Hospital: lead
• National University of Singapore: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus; Medication Adherence; Patient Compliance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Hua Heng McVin Cheen, B.Sc (Pharm)

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 7, 2014
• Study Start: August 1, 2014
• Primary Completion: March 1, 2015
• Last Updated: February 10, 2017

Record last verified: 2017-02

Locations

SG (1)