Risk-informed Shared-decision Making Engagement Strategy for Patients With Prediabetes

Part of paid clinical trials in Frederick, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07553325
Status
Not Yet Recruiting

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Conditions

  • Prediabetes
  • Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Risk Informed Shared Decision-Making Strategy (RISE) — OTHER
    Single visit with health care team member to discuss diabetes risk and choosing next steps
  • Low Touch Messaging Strategy (LTM) — OTHER
    Single message delivered via patient portal system describing diabetes risk and tips to lower risk

Study Details

The goal of this clinical trial is to learn if knowing risk for diabetes can help adult patients with prediabetes take steps to get care and prevent diabetes. The main questions it aims to answer are: * Does a shared-decision making visit with a health care team member to talk about the participant's diabetes risk increase participants' taking steps to prevent diabetes? * Does a simple message in the patient portal about the participant's diabetes risk increase participants' taking steps to prevent diabetes? Researchers will compare the visit with usual care at the clinic to see if the visit increases participants' taking steps to prevent diabetes. Separately, the researchers will compare the patient message with usual care at the clinic to see if the message increases participants' taking steps to prevent diabetes. Participants will: * Complete surveys at the beginning of the study and up to 2 additional surveys * If the participant falls into the shared decision-making group, the participant will have one 30-minute visit with a healthcare team member to talk about risk of diabetes and how to lower it.

Key Dates

Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Sep 1, 2027
Completion
Apr 1, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Risk-Informed Shared Decision-Making Engagement Strategy
    Participants will have one visit with a healthcare team member to talk about the participant's risk of diabetes and how to lower it.
  • Active Comparator: Low Touch Messaging Strategy
    Participants receive a simple message in the patient portal describing the participant's level of risk of diabetes and tips on how to lower the risk
  • No Intervention: Usual Care
    Participants will continue with usual care at the clinic

Primary Outcome Measure

Presence of a DPP referral or new metformin prescription [ Time Frame: From randomization to 3 months after randomization ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Community Physicians FrederickFrederickMaryland21702
Eva Tseng, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
Johns Hopkins Community Physicians Frederick· Frederick, MD

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