ClinicalTrials.gg
Enrolling by invitationNCT06358261Updated Sep 3, 2026

Study of a Diabetes Prevention Patient Activation Clinical Decision Support Tool

An interventional study of Diabetes Prevention Patient Activation Clinical Decision Support Tool in PreDiabetes, Lifestyle, Healthy and Activation, Patient, sponsored by Johns Hopkins University. Enrolling by invitation at 1 site in United States. Open to participants aged 25 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by Johns Hopkins University · Not applicable, Interventional, and Prevention

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Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
25 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 12 studies in Prediabetic State by Johns Hopkins University — 4 open to participants now, 4 under way, none of them phase 3. Prediabetic State · Johns Hopkins University.

Planned enrollment
4th of 12
100 · median 65
Started
2024
the only one that year
No phase
11 of 12
4 open now
Registered
10th of 12
by date

Among the 12 studies in Prediabetic State by Johns Hopkins University, this one is the 4th largest by planned enrollment, is the only one that started in 2024, is one of 11 with no phase, and was the 10th registered.

Prediabetic State

918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.

Browse Prediabetic State studies →

Open to participants now

4 of the 12 studies in Prediabetic State by Johns Hopkins University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Where they have run

Who these studies take

Of the 145 Prediabetic State studies recruiting now, 51 (35%) set no upper age limit and 84 (58%) stop at 75 or younger; 12 take children under 18; 54 take healthy volunteers.

This study: 25 Years to 75 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 12 studies in Prediabetic State by Johns Hopkins University, or all of them as a file.
02

Study summary

The investigators overarching goal is to increase the percentage of patients engaging in diabetes prevention activities to reduce the incidence of diabetes. The investigators objective is to design and pilot test a prediabetes clinical decision support (CDS) tool in the electronic health record (EHR) that will assess the patient's activation level based on responses to a questionnaire. Based on the patient's assessed level of activation, the tool will generate several communication recommendations to guide clinicians in conversations related to prediabetes/lifestyle change and tailor recommendations about available resources (e.g., care manager, health coach, DPP) to support patient activation.

Read the detailed description

Patient activation, which incorporates elements of self-efficacy and readiness to change, is particularly important in managing conditions like pre-diabetes, where the mainstay of treatment is behavioral lifestyle change and self-management. Unfortunately, Primary Care Physicians (PCPs) often do not have adequate training on how to promote patient activation. Traditionally, patient decision aids are used in shared decision-making to help elicit patient preferences and guide treatment options. However, the guides primarily focus on reviewing treatment options rather than increasing patient activation, which is key to successful and efficient behavioral counseling. The Patient Activation Measure (PAM) is a widely used and validated patient-reported outcome measure for assessing patient activation. Studies have demonstrated that using PAM to tailor care to a patient's activation level decreased health service utilization while improving clinical outcomes like blood pressure and self-management behaviors.

The investigators overarching goal is to increase the percentage of patients engaging in diabetes prevention activities to reduce the incidence of diabetes. The investigators objective is to design and pilot test a pre-diabetes clinical decision support (CDS) tool in the electronic health record (EHR) that will assess the patient's activation level based on responses to a questionnaire. Based on the patient's assessed level of activation, the tool will generate several communication recommendations to guide clinicians in conversations related to pre-diabetes/lifestyle change and tailor recommendations about available resources (e.g., care manager, health coach, DPP) to support patient activation.

03

Conditions studied

  • PreDiabetes
  • Lifestyle, Healthy
  • Activation, Patient
04

Who can participate

Ages eligible
25 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • prediabetes
  • patient at Johns Hopkins General Internal Medicine clinic at Green Spring Station
  • MyChart account

Exclusion criteria

Exclusion Criteria:

  • history of diabetes
  • non-English speaker
  • severe intellectual disability or psychiatric comorbidities
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Intervention Arm (DPACT)

    In this arm, patients will have at least 2 visits with the participants primary care doctor. Before each visit, participants will complete a patient activation survey. Results of the survey will be shared with the primary care doctor and entered into the medical record so that the Diabetes Prevention Patient Activation Clinical Decision Support Tool can be used by the participants doctor during the visit to discuss lifestyle management.

    Behavioral: Diabetes Prevention Patient Activation Clinical Decision Support Tool

  • No intervention
    Control Arm (Usual Care)

    Patients in the control arm will follow the same visit schedule as the intervention arm. At the beginning of the study, participants will receive a handout on pre-diabetes which will include information on lifestyle changes and the benefits of joining a Diabetes Prevention Program. Before each visit, participants will complete a patient activation survey but the results will not be shared with the participants primary care doctor

Interventions

  • BehavioralDiabetes Prevention Patient Activation Clinical Decision Support Tool

    Diabetes Prevention Patient Activation Clinical Decision Support Tool will be used by the doctor during the visit to discuss lifestyle management

06

What researchers measure

Primary outcomes

  1. patient activation as assessed by the Patient Activation Measure Survey (PAM)

    measured by Patient Activation Measure (PAM) survey, a 13-item scale with 4 Likert response,s and scores ranging from 0 to 100 (higher score means higher activation level)

    Time frame: baseline, 6 months

Secondary outcomes

  1. number of participants referred to Diabetes Prevention Program

    measured using electronic health record data

    Time frame: baseline, 6 months

  2. number of participants prescribed metformin

    measured using electronic health record data

    Time frame: baseline, 6 months

  3. percent of participants who make diet changes

    measured using survey developed by study team will assess what diet changes participants have made

    Time frame: baseline, 6 months

  4. change in amount and frequency of physical activity

    measured using survey developed by study team will assess the change in amount and frequency of physical activity that participants have made

    Time frame: baseline, 6 months

07

Study locations

1 site
  • Johns Hopkins Internal Medicine at Green Spring Station
    Lutherville, Maryland 21093, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for Jan 2027, 30 months after the start.

Of 378 non-industry interventional studies with no phase under Prediabetic State, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 39. This study's planned 30 months is above that.

Counting every sponsor, half of 424 studies reached it within 23 months; a quarter within 11 and three quarters within 37.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 5, 2024
First posted
Apr 10, 2024
StartActual
Jul 1, 2024
Primary completionEst.
Jan 1, 2027
CompletionEst.
Feb 1, 2027
Last update
Sep 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06358261
Responsible party
Sponsor
First posted
Apr 10, 2024
Start date
Jul 1, 2024
Primary completion
Jan 1, 2027 (estimated)
Completion
Feb 1, 2027 (estimated)
Last update
Sep 3, 2026

Study contacts

Eva Tseng, MD
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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