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

August 27, 2026 updated by: Johns Hopkins University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Frederick, Maryland, United States, 21702
        • Recruiting
        • Johns Hopkins Community Physicians Frederick
        • Principal Investigator:
          • Eva Tseng, MD, MPH
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Risk Informed Shared Decision-Making Strategy (RISE)
Single visit with health care team member to discuss diabetes risk and choosing next steps
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
Other: Low Touch Messaging Strategy (LTM)
Single message delivered via patient portal system describing diabetes risk and tips to lower risk
No Intervention: Usual Care
Participants will continue with usual care at the clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From randomization to 3 months after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 -
Referral to 6 months after DPP referral
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
From enrollment to 12 months of follow-up
Weight change (kg)
Time Frame: From enrollment to 12 months
Change in body weight
From enrollment to 12 months
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).
From enrollment to 12 months
Hemoglobin A1c change
Time Frame: From enrollment to 12 months
Absolute change in hemoglobin A1c
From enrollment to 12 months
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)
From enrollment to 3 months and from enrollment to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

American Diabetes Association

Investigators

  • Principal Investigator: Eva Tseng, MD, MPH, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

April 20, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 28, 2026

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00538220

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Only de-identified IPD used in the results publication will be shared

IPD Sharing Time Frame

Beginning 1 year after publication with no end date

IPD Sharing Access Criteria

All de-identified datasets that can be shared will be deposited in figshare, an open access ADA-approved repository.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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