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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Recruitment Status : Withdrawn (Poor patient recruitment)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

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Other: Mobile application Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Smartphone Application to Improve Medication Adherence Among People With Type 2 Diabetes Mellitus in Singapore: A Randomized Controlled Trial
Study Start Date : August 2014
Estimated Primary Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mobile application Other: Mobile application
The intervention in this study is a mobile application which will be downloaded into the participant's smartphone.

No Intervention: Standard care



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in HbA1c [ Time Frame: Baseline (at recruitment) and 6 months (+/- 4 weeks) ]
    Part of routine monitoring during doctor's appointment

  2. Change in blood glucose [ Time Frame: Baseline (at recruitment) and 6 months (+/- 4 weeks) ]
    Part of routine monitoring during doctor's appointment

  3. Frequency of dose titrations of oral hypoglycemic agents and insulin [ Time Frame: 6 months (+/- 4 weeks) after recruitment ]
  4. Addition or removal of oral hypoglycemic agents and insulin [ Time Frame: 6 months (+/- 4 weeks) after recruitment ]
  5. 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

  6. Change in health status [ Time Frame: Baseline (at recruitment) and 6 months (+/- 4 weeks) ]
    Measured using EuroQol-5D-5L and EuroQol Visual Analogue Scale.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105597


Locations
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Singapore
Singapore General Hospital
Singapore, Singapore, 169608
Sponsors and Collaborators
Singapore General Hospital
National University, Singapore
Investigators
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Principal Investigator: Hua Heng McVin Cheen, B.Sc (Pharm) Singapore General Hospital

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Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT02105597     History of Changes
Other Study ID Numbers: iADHERE-01
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017

Keywords provided by Singapore General Hospital:
Diabetes mellitus
Medication adherence
Compliance
Mobile health

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases