Diabetes Risk Education and Communication Trial
DiRECT
2 other identifiers
interventional
53
1 country
1
Brief Summary
A large body of research has demonstrated that intensive lifestyle interventions and metformin are effective treatments to prevent or delay diabetes among high-risk adults, yet neither treatment is routinely used in practice. This pilot study will develop and evaluate the Diabetes Risk Education and Communication Trial (DiRECT) intervention, which communicates information about diabetes risk and treatment options for preventing diabetes among primary care patients with prediabetes. Given that 38% of U.S. adults have prediabetes, this project has large potential to impact public health by developing a scalable intervention to promote the use of evidence-based treatments that lower diabetes risk in this population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2017
CompletedFirst Posted
Study publicly available on registry
September 14, 2017
CompletedStudy Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2019
CompletedMarch 7, 2022
March 1, 2022
1.4 years
August 22, 2017
March 3, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Intent to treat questionnaire: Participant initiation of treatment to intensive lifestyle (ILI) or Metformin
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.
3 months
Study Arms (2)
DiRECT
EXPERIMENTALDiRECT 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.
Usual Care (UC)
ACTIVE COMPARATORParticipants randomized to standard care will receive routine medical care without the medical assistant delivered DiRECT intervention.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Overweight or obesity
- documentation of prediabetes in medical chart or
- A1c 5.7-6.4
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern University
Chicago, Illinois, 60611, United States
Related Publications (1)
O'Brien MJ, Cameron KA, Vargas MC, Mohr L, Williams GC, Fagerlin A, Kandula NR. Evaluation of a Prediabetes Decision Aid on Patient-Reported Outcomes in Primary Care: a Pilot Study. J Gen Intern Med. 2021 Mar;36(3):824-826. doi: 10.1007/s11606-020-05936-6. Epub 2020 Jun 15. No abstract available.
PMID: 32542497DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew J O'Brien
Assistant Professor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 22, 2017
First Posted
September 14, 2017
Study Start
November 1, 2017
Primary Completion
March 17, 2019
Study Completion
March 17, 2019
Last Updated
March 7, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share