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Trial to Incentivise Adherence for Diabetes (TRIAD)

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ClinicalTrials.gov Identifier: NCT02224417
Recruitment Status : Completed
First Posted : August 25, 2014
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Marcel Bilger, Duke-NUS Graduate Medical School

Brief Summary:
Type II diabetes is associated with a host of adverse and costly complications, including heart attacks, strokes, blindness, kidney failure, and severe neuropathy that may result in amputations. For those with diabetes, glycemic control is essential to minimize complications but many fail at being sufficiently adherent to their treatment. The investigators propose to test two incentive-based intervention strategies aimed at improving diabetes outcomes amongst patients with uncontrolled glycemic levels. The incentives are tied either to processes aimed at improving blood sugar levels (glucose testing, physical activity and medication adherence) or directly to the intermediary outcome (blood glucose in the acceptable range). While process incentives are likely to provide more motivation for treatment adherence, as these goals may be comparably easier to meet, these incentives only reward intermediary outcomes and it might be more effective to reward successfully achieving a health outcome directly.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Behavioral: Diabetes Educational Program (DEP) Behavioral: DEP + Process Incentive Behavioral: DEP + Outcome Incentive Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Randomized Controlled Trial to Improve Diabetes Outcomes Through Financial Incentives
Study Start Date : March 2015
Actual Primary Completion Date : October 25, 2018
Actual Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Diabetes Educational Program (DEP) only
Participants will receive the Diabetes Educational Program, as required, which is part of usual care at the Polyclinic. They will receive the Fitbit ™, the eCAP, and a glucometer (if they do not already have one).
Behavioral: Diabetes Educational Program (DEP)

Participants in this Arm will receive the Diabetes Educational Program (DEP), as required, which is part of usual care at the Polyclinic. It is delivered by a Health Counsellor at the point of diagnosis and focused education is provided during doctor visits for medication. The program at the Polyclinic comprises information on a series of diabetes-related issues.

The participant will receive the 2 or 3 study devices (patients will receive a glucometer if they do not already have one). The Site Study Coordinator will provide education on the use of the Fitbit Zip™ and the eCAP™. As part of usual care, patients who have difficulties with their glucometer will be referred to a Health Counsellor at the Polyclinic.


DEP + Process Incentive Arm
Participants will receive the Diabetes Educational Program, as required. They will receive the Fitbit ™, the eCAP, and a glucometer (if they do not already have one). They will also have the opportunity to earn financial incentives for meeting specified process goals.
Behavioral: Diabetes Educational Program (DEP)

Participants in this Arm will receive the Diabetes Educational Program (DEP), as required, which is part of usual care at the Polyclinic. It is delivered by a Health Counsellor at the point of diagnosis and focused education is provided during doctor visits for medication. The program at the Polyclinic comprises information on a series of diabetes-related issues.

The participant will receive the 2 or 3 study devices (patients will receive a glucometer if they do not already have one). The Site Study Coordinator will provide education on the use of the Fitbit Zip™ and the eCAP™. As part of usual care, patients who have difficulties with their glucometer will be referred to a Health Counsellor at the Polyclinic.


Behavioral: DEP + Process Incentive

Participants will receive the DEP as required. In addition, participants will have the opportunity to earn financial incentives (in vouchers) for meeting specified goals:

  • SGD3.50 weekly for meeting Glucose testing goals: measuring blood glucose on three non-consecutive days each week.
  • SGD0.50 daily for Medication adherence: taking medications daily as prescribed, monitored by eCAP device. Assessed based on medication-taking times within specified time windows. Participants should be adherent at all specified mealtimes to be fully adherent for the day.
  • SGD1.00 daily for Regular Physical activity: taking 8,000 steps during the day as recorded by Fitbit.

DEP + Outcome Incentive Arm
Participants will receive the Diabetes Educational Program, as required. They will receive the Fitbit ™, the eCAP, and a glucometer (if they do not already have one). They will also have the opportunity to earn financial incentives for meeting specified outcome goals.
Behavioral: Diabetes Educational Program (DEP)

Participants in this Arm will receive the Diabetes Educational Program (DEP), as required, which is part of usual care at the Polyclinic. It is delivered by a Health Counsellor at the point of diagnosis and focused education is provided during doctor visits for medication. The program at the Polyclinic comprises information on a series of diabetes-related issues.

The participant will receive the 2 or 3 study devices (patients will receive a glucometer if they do not already have one). The Site Study Coordinator will provide education on the use of the Fitbit Zip™ and the eCAP™. As part of usual care, patients who have difficulties with their glucometer will be referred to a Health Counsellor at the Polyclinic.


Behavioral: DEP + Outcome Incentive

Participants will receive the DEP as required. In addition, participants will have the opportunity to earn financial incentives (in vouchers) for recording glucose readings within the normal range (i.e. between 4 to 7mmols/L two before a meal) on 3 non-consecutive days within the week using the glucometer.

  • SGD 2 weekly if one glucose readings falls within the normal range,
  • SGD 7 weekly if two glucose readings fall within the normal range,
  • SGD 14 weekly if all three glucose readings fall within the normal range.




Primary Outcome Measures :
  1. HbA1c levels [ Time Frame: Baseline, Week 12 and Week 24 ]
    HbA1c levels will be the health outcome variable. HbA1c measures the metabolic control of diabetes, with normal values (well controlled blood glucose levels) below 7%. We hypothesise that participants with high adherence levels will have lower HbA1c levels and be more likely to have healthy (below 7%) HbA1c levels compared to less adherent participants, all being equal.


Secondary Outcome Measures :
  1. Physical activity [ Time Frame: Months 1 to 6 ]
    Fitbit data will be analysed to determine whether the average number of days that participants achieved the daily activity goal (8,000 or more steps per day) differs by intervention arm. Data will be reviewed for all time points, however the focus will be on physical activity in the final month of the study, which will provide the greatest evidence of potential long term behaviour change.

  2. Medication Adherence [ Time Frame: Months 1 to 6 ]
    Dose-rate adherence percentage for the last month of the study, as measured by the eCAP device. The dose-rate adherence percentage measures the proportion of times the participant took the medication within all specified pre-established dosing schedule. (Data will be reviewed for all time points, however the focus will be on the last month of the study).

  3. Glucose testing rates [ Time Frame: Months 1 to 6 ]
    Glucose testing rates measure the proportion of days within the month that the participant tested their blood glucose levels where the denominator is the level of testing recommended by the clinician.

  4. Glucose testing within range [ Time Frame: Months 1 to 6 ]
    The proportion of days within the month that the participant tested their blood glucose levels and the test results were within specified ranges.



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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants need to be uncontrolled diabetics at Baseline. Uncontrolled diabetes is defined by a HbA1c level 8.0 or greater. Participants will be required to have at least 1 of 2 HbA1c readings 8.0 or greater in the past 6 months.
  • Be prescribed at least one diabetic medication for at least three months and be willing to have this verified by a physician.
  • Be Singaporean citizens or Permanent Residents.
  • Be able to converse in English or Mandarin.

Exclusion Criteria:

  • Individuals on inject-able insulin therapy.
  • Individuals with significant co-morbid conditions such that they are unlikely to be able to take their medications without assistance from a third party.
  • Individuals who are pregnant.
  • Individuals who fail the PARQ and do not obtain doctor's consent.

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): NCT02224417


Locations
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Singapore
SingHealth Polyclinics (Geylang)
Singapore, Singapore, 389707
SingHealth Polyclinic (Bedok)
Singapore, Singapore, 469662
Sponsors and Collaborators
Duke-NUS Graduate Medical School
Investigators
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Principal Investigator: Marcel Bilger Duke-NUS Graduate Medical School
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marcel Bilger, Assistant Professor, Duke-NUS Graduate Medical School
ClinicalTrials.gov Identifier: NCT02224417    
Other Study ID Numbers: NIHA-2013-1-005
First Posted: August 25, 2014    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Keywords provided by Marcel Bilger, Duke-NUS Graduate Medical School:
Diabetes
Treatment medication adherence
Physical activity
Financial incentives
Outcome incentives
Process incentives
HbA1c
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases