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NCT Number: NCT07553325

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

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.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Prediabetes (Insulin Resistance, Impaired Glucose Tolerance) Prediabetic State

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Community Physicians Frederick

Frederick, Maryland, 21702, United States

Location contact

Eva Tseng, MD, MPH

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • prediabetes based on most recent HbA1c (5.7-6.4%) or fasting plasma glucose (100-125 mg/dL) in prior 12 months
  • active patient portal account (MyChart)
  • patient receiving primary care at Johns Hopkins Community Physicians in Frederick
  • have overweight or obesity (BMI ≥ 25 kg/m2)

Exclusion criteria

  • have diabetes (HbA1c > 6.4% in prior 6 months or on diabetes registry)
  • have dementia
  • previously participated in the Diabetes Prevention Program (DPP)

Treatment and study plan

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

Primary outcomes

  1. Presence of a DPP referral or new metformin prescription

    Time frame: From randomization to 3 months after randomization

    Prediabetes treatment uptake - Presence of a DPP referral or new metformin prescription based on electronic health record data

Secondary outcomes

  1. Proportion of patients enrolled in the DPP

    Time frame: Referral to 6 months after DPP referral

    DPP enrollment- Proportion of patients enrolled in the DPP -

  2. Proportion of patients who complete ≥ 9 months of the DPP

    Time frame: From enrollment to 12 months of follow-up

    DPP completion- Proportion of patients who complete ≥ 9 months of the DPP

  3. Weight change (kg)

    Time frame: From enrollment to 12 months

    Change in body weight

  4. Metformin adherence

    Time frame: From enrollment to 12 months

    Proportion of participants with a new metformin prescription who have a proportion-of-days covered (PDC) value of ≥0.80 (calculated as the sum of days' supply of metformin divided by the number of days between the first fill and end of follow-up period).

  5. Hemoglobin A1c change

    Time frame: From enrollment to 12 months

    Absolute change in hemoglobin A1c

  6. Patient Activation Measure

    Time frame: From enrollment to 3 months and from enrollment to 12 months

    Patient Activation Measure (PAM) scored as Level 1(disengaged) - 4 (proactive)

Study contacts

Contact information is provided by the study sponsor or research team.

Eva Tseng, MD, MPH

CONTACT

[email protected]

Research Study Coordinator

CONTACT

[email protected]

410-614-4396

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • American Diabetes Association

Registry information

Official study title

Pilot Trial of a Risk-informed Shared-decision Engagement Strategy

Acronym: RISE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 28, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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