Diabetes MellitusiADHERENCT02105597
A Smartphone Application to Improve Medication Adherence Among People With Type 2 Diabetes Mellitus in Singapore
A study testing Mobile application in people with Diabetes Mellitus, run by Singapore General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Mobile application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Mobile application
- Keywords
- Diabetes mellitus, Medication adherence, Compliance, Mobile health
- Medical subject headings
- Diabetes Mellitus, Medication Adherence, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile applicationOther
The intervention in this study is a mobile application which will be downloaded into the participant's smartphone.
| Study group | Role | What they receive |
|---|---|---|
| Mobile application | Experimental | Not described Receives: Other: Mobile application |
| Standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported medication adherence
Self-reported medication adherence will be assessed using the 8-item Morisky Medication Adherence Scale.
Measured: Baseline (at recruitment) and 6 months (+/- 4 weeks)
Secondary outcomes (6)
Change in HbA1c
Part of routine monitoring during doctor's appointment
Measured: Baseline (at recruitment) and 6 months (+/- 4 weeks)
Change in blood glucose
Part of routine monitoring during doctor's appointment
Measured: Baseline (at recruitment) and 6 months (+/- 4 weeks)
Frequency of dose titrations of oral hypoglycemic agents and insulin
Measured: 6 months (+/- 4 weeks) after recruitment
Addition or removal of oral hypoglycemic agents and insulin
Measured: 6 months (+/- 4 weeks) after recruitment
Change in health-related quality of life
Measured using Audit of Diabetes Dependent Quality of Life - 19 (ADDQoL-19) questionnaire
Measured: Baseline (at recruitment) and 6 months (+/- 4 weeks)
Change in health status
Measured using EuroQol-5D-5L and EuroQol Visual Analogue Scale.
Measured: Baseline (at recruitment) and 6 months (+/- 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2015 (estimated)
Why it stopped: Poor patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Sponsor
- Investigators
- Hua Heng McVin Cheen, B.Sc (Pharm), Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105597
- Sponsor's protocol ID
- iADHERE-01
- Acronym
- iADHERE
- Status last verified
- Feb 2017
- First submitted
- 28 Mar 2014
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Smartphone Application to Improve Medication Adherence Among People With Type 2 Diabetes Mellitus in Singapore: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02105597
- Acronym / sponsor ID
- iADHERE / iADHERE-01
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes mellitus, Medication adherence, Compliance, Mobile health
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Poor patient recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- Aug 2014
- Primary completion
- Mar 2015 (estimated)
- First posted
- 7 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile application | Experimental | Other: Mobile application |
| Standard care | No intervention | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile applicationThe intervention in this study is a mobile application which will be downloaded into the participant's smartphone. | Other | Mobile application |
Primary outcome
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.
6 secondary outcomes
Change in HbA1c
Time frame: Baseline (at recruitment) and 6 months (+/- 4 weeks)
Change in blood glucose
Time frame: 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
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)
Change in health status
Time frame: Baseline (at recruitment) and 6 months (+/- 4 weeks)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hua Heng McVin Cheen, B.Sc (Pharm) principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile application in people with Diabetes Mellitus, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported medication adherence (time frame: Baseline (at recruitment) and 6 months (+/- 4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017.