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

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ClinicalTrials.gov Identifier: NCT02105597
Recruitment Status : Withdrawn (Poor patient recruitment)
First Posted : April 7, 2014
Last Update Posted : February 10, 2017
Sponsor:
Collaborator:
National University, Singapore
Information provided by (Responsible Party):
Singapore General Hospital

Tracking Information
First Submitted Date  ICMJE March 28, 2014
First Posted Date  ICMJE April 7, 2014
Last Update Posted Date February 10, 2017
Study Start Date  ICMJE August 2014
Estimated Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02105597 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2014)
  • Change in HbA1c [ Time Frame: Baseline (at recruitment) and 6 months (+/- 4 weeks) ]
    Part of routine monitoring during doctor's appointment
  • Change in blood glucose [ Time Frame: Baseline (at recruitment) and 6 months (+/- 4 weeks) ]
    Part of routine monitoring during doctor's appointment
  • Frequency of dose titrations of oral hypoglycemic agents and insulin [ Time Frame: 6 months (+/- 4 weeks) after recruitment ]
  • Addition or removal of oral hypoglycemic agents and insulin [ Time Frame: 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
  • Change in health status [ Time Frame: Baseline (at recruitment) and 6 months (+/- 4 weeks) ]
    Measured using EuroQol-5D-5L and EuroQol Visual Analogue Scale.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Smartphone Application to Improve Medication Adherence Among People With Type 2 Diabetes Mellitus in Singapore
Official Title  ICMJE A Smartphone Application to Improve Medication Adherence Among People With Type 2 Diabetes Mellitus in Singapore: A Randomized Controlled Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE Other: Mobile application
The intervention in this study is a mobile application which will be downloaded into the participant's smartphone.
Study Arms  ICMJE
  • Experimental: Mobile application
    Intervention: Other: Mobile application
  • No Intervention: Standard care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 18, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 2, 2014)
210
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02105597
Other Study ID Numbers  ICMJE iADHERE-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Singapore General Hospital
Study Sponsor  ICMJE Singapore General Hospital
Collaborators  ICMJE National University, Singapore
Investigators  ICMJE
Principal Investigator: Hua Heng McVin Cheen, B.Sc (Pharm) Singapore General Hospital
PRS Account Singapore General Hospital
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP