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NCT02324036 · ClinicalTrials.gov registry record · Early Phase 1

The EMPATHy Toolkit: Helping Diabetes Patients Overcome Barriers to Medication Adherence

A Early Phase 1 study, sponsored by University of California, Irvine.

Completed
Registry status
Early Phase 1
Development phase
190
Enrollment target

NCT02324036: Completed Early Phase 1 study, sponsored by University of California, Irvine.

NCT02324036 is a Early Phase 1 study that has completed, run by University of California, Irvine. The registered enrollment target is 190 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (258% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02324036, a Early Phase 1 study, has completed, sponsored by University of California, Irvine.

COMPLETED
Registry status
Early Phase 1
Development phase
190 participants
Enrollment target

Study Summary

The proposed study is a pilot study to gather data on the effectiveness and feasibility of a software tool (EMPATHy) to help patients communicate effectively with doctors about problems they face with their medication regimens. EMPATHy will be incorporated into an existing clinic-based intervention called Coached Care, in which community health workers (CHWs, non-professional community members) work as a "Coach" to patients to help them improve engagement and communication during the medical visit.

Primary Outcome

Development of a contextualized plan of care will be assessed by analyzing an audio recording of the medical visit, using a previously developed coding scheme (see Research Methodology). If the coder concludes that the plan of care discussed in the visit adequately addresses a contextual factor raised during the visit, it will be determined that a contextualized plan of care was developed.

Interventions

  • BEHAVIORAL Coached Care
  • DEVICE EMPATHy Toolkit

Trial Details

FieldValue
Enrollment Target 190 participants
Start Date 2014-12
Est. Completion 2015-08
Phase Early Phase 1
University of California, Irvine

368 total trials

What the finished NCT02324036 record still lists

NCT02324036 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (258% higher).

The record links to 0 conditions, and to 2 interventions - of which Coached Care is the first listed.

NCT02324036 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02324036 about?

NCT02324036 is a clinical study titled "The EMPATHy Toolkit: Helping Diabetes Patients Overcome Barriers to Medication Adherence". The proposed study is a pilot study to gather data on the effectiveness and feasibility of a software tool (EMPATHy) to help patients communicate effectively with doctors about problems they face with their medication regimens. EMPATHy will be incorporated into an existing clinic-based intervention ...

What is the current status of trial NCT02324036?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 190 participants. The study started on 2014-12. Estimated completion is 2015-08.

What interventions are being tested in trial NCT02324036?

The interventions under investigation include: Coached Care (BEHAVIORAL), EMPATHy Toolkit (DEVICE).

Who is sponsoring clinical trial NCT02324036?

This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02324036's enrollment target sits among peer trials

190 71st of 2000 higher than 1,928 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02324036, the US trial registry maintained by the National Library of Medicine. NCT02324036 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.