Diabetes Risk Education and Communication Trial

Diabetes Mellitus, Type 2 Clinical Trial

— DiRECT  

Official title:

Diabetes Risk Education and Communication Trial (DiRECT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03283657
• Other study ID #: STU00204220
• Secondary ID: R34DK113541
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: March 17, 2019

Study information

• Verified date: March 2022
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: March 17, 2019
• Est. primary completion date: March 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• PreDiabetes

Intervention

Behavioral:
• DiRECT
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.
• Usual care (UC)
Standard care with routine medical care.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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