- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03283657
Diabetes Risk Education and Communication Trial (DiRECT)
Diabetes Risk Education and Communication Trial (DiRECT)
Study Overview
Status
Intervention / Treatment
Detailed Description
Landmark clinical trials have found that intensive lifestyle interventions (ILI) and metformin are safe and effective treatment options for preventing diabetes among adults with prediabetes and overweight/obesity. Despite being included in expert clinical guidelines, these treatments are rarely used in practice and little existing research has focused on approaches for promoting their use.
This novel intervention, delivered by medical assistants before patients' routinely scheduled office visits, consists of the following 3 components intended to promote initiation of ILI and metformin: 1) a prediabetes decision aid focused on diabetes risk and treatment options for preventing diabetes; 2) a "think aloud" exercise; and 3) formulating a preliminary treatment plan. Previous studies report that medical assistants can improve uptake of some preventive health services in primary care, which may also be true for ILI and metformin.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Overweight or obesity
- documentation of prediabetes in medical chart or
- A1c 5.7-6.4
Exclusion Criteria:
- Age < 18; individuals who are not yet adults (infants, children, teenagers)
- Patient's primary care physician did not provide permission to participate in the study
- Pregnancy status: current or planned pregnancy during study period
- Serum creatinine >1.4mg/dL in women and >1.5mg/dL in men
- Patients that are blind, deaf, or otherwise unable to review study materials
- Prior diagnosis of diabetes mellitus type 1 or type 2 or on antidiabetic medication
- Diagnosis of post-surgical hypoinsulinemia
- Diagnosis of dementia
- Uncontrolled hypertension (≥160/100 mm Hg)
- No office visit in past 12 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: DiRECT
DiRECT consists of the following components that will be delivered by medical assistants before patients' routinely scheduled office visits: 1) a prediabetes decision aid focused on type 2 diabetes (T2D) risk and treatment options for preventing T2D; 2) a 'think aloud' exercise; and 3) formulating a preliminary treatment plan for T2D prevention.
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DiRECT participants will meet with a medical assistant (MA) before a routinely scheduled office and formulate a preliminary treatment plan for T2D prevention.
Participants will attend their scheduled physician visit, during which they may make a definitive treatment plan to initiate metformin and/or ILI.
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Active Comparator: Usual Care (UC)
Participants randomized to standard care will receive routine medical care without the medical assistant delivered DiRECT intervention.
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Standard care with routine medical care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intent to treat questionnaire: Participant initiation of treatment to intensive lifestyle (ILI) or Metformin
Time Frame: 3 months
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The number of participants that initiate ILI, Metformin, or both treatments at follow-up is the primary outcome of the pilot trial, which will be assessed in the following ways.
Because initiation of metformin requires a provider prescription, this will be assessed pragmatically using the electronic health record (EHR) and confirmed by participant self-report of taking at least 1 dose.
Attendance logs will be used to confirm whether participants attended at least 1 ILI session.
Those who received a prescription for metformin but do not take any doses will not be considered to have initiated treatment.
Similarly, those who are referred to ILI but do not attend any sessions will not be classified as initiating treatment.
Receiving a provider's prescription for metformin or referral for ILI without initiating treatment will be an exploratory outcome.
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3 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Matthew J O'Brien, Assistant professor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00204220
- R34DK113541 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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