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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02224417 |
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Date of registration:
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22/08/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Trial to Incentivise Adherence for Diabetes
TRIAD |
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Scientific title:
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A Randomized Controlled Trial to Improve Diabetes Outcomes Through Financial Incentives |
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Date of first enrolment:
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March 2015 |
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Target sample size:
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240 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02224417 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Singapore
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Contacts
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Name:
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Marcel Bilger |
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Address:
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Telephone:
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Email:
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Affiliation:
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Duke-NUS Graduate Medical School |
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Key inclusion & exclusion criteria
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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.
Age minimum:
21 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes Mellitus
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Intervention(s)
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Behavioral: Diabetes Educational Program (DEP)
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Behavioral: DEP + Outcome Incentive
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Behavioral: DEP + Process Incentive
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Primary Outcome(s)
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HbA1c levels
[Time Frame: Baseline, Week 12 and Week 24]
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Secondary Outcome(s)
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Glucose testing rates
[Time Frame: Months 1 to 6]
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Glucose testing within range
[Time Frame: Months 1 to 6]
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Physical activity
[Time Frame: Months 1 to 6]
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Medication Adherence
[Time Frame: Months 1 to 6]
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Secondary ID(s)
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NIHA-2013-1-005
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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