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NCT02834923 · ClinicalTrials.gov registry record · NA

Enhancing Self-Management Support in Diabetes Through Patient Engagement

A NA study of Diabetes Mellitus, Type 2, sponsored by University of California, San Francisco.

Completed
Registry status
NA
Development phase
725
Enrollment target
1
Study location

NCT02834923 is a NA study of Diabetes Mellitus, Type 2 that has completed, run by University of California, San Francisco. The registered enrollment target is 725 participants, below the 4,483-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02834923, a NA study of Diabetes Mellitus, Type 2, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
NA
Development phase
725 participants
Enrollment target
1
Study location

Study Summary

The Patient Centered Medical Home (PCMH) and the Chronic Care Model (CCM) are complementary clinical intervention frameworks that are commonly invoked to support better type 2 diabetes (T2DM) outcomes in primary care. Self-management Support (SMS) is a core component of both the PCMH and CCM, and focuses on the central role of patients in managing their illness by engaging with and adopting healthy behaviors that promote optimal clinical outcomes. Despite its recognized importance, SMS programs for diabetes continue to demonstrate limited effectiveness in the real-world of primary care. SMS is comprised of two complementary and interactive components: (1) patient engagement (e.g., the process of eliciting and responding to patients emotions and motivations related to health behaviors), and (2) behavioral change tools (e.g., selecting specific goals, creating action plans). While several sophisticated SMS programs have been developed for T2DM, the vast majority are designed with a narrow focus on behavioral change tools, largely ignoring unique aspects of the patient context that drive and maintain health behavior. Considerable clinical research suggests that the addition of a structured, evidenced-based program of patient engagement can maximize the effectiveness of SMS programs for patients with T2DM in primary care. To date there has been no systematic study of the degree to which fully integrating enhanced patient engagement as part of SMS will increase the initiation and maintenance of behavior change over time, and for which kinds of patients enhanced patient engagement is essential. To address this gap, the investigators will compare a state-of-the-art, evidence-based SMS behavior change tool program, called Connection to Health (CTH), with an enhanced CTH program that includes a practical, time-efficient patient engagement protocol, to create a program with an integrated and comprehensive approach to SMS, called "Enhanced Engagement CTH" (EE-CTH). The curre

Conditions Studied

Interventions

  • BEHAVIORAL Enhanced Engagement Protocol for CTH (EE-CTH)
  • BEHAVIORAL Connection to Health (CTH)

Study Locations (1)

California

  • University of California, San Francisco - San Francisco

Trial Details

FieldValue
Enrollment Target 725 participants
Start Date 2016-10
Est. Completion 2020-12-20
Phase NA

What the Registry Record Tells You About NCT02834923

The ClinicalTrials.gov registry entry for NCT02834923 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 725 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,483-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (84% lower). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Enhanced Engagement Protocol for CTH (EE-CTH) is the first listed.

NCT02834923 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT02834923 about?

NCT02834923 is a clinical study titled "Enhancing Self-Management Support in Diabetes Through Patient Engagement". The Patient Centered Medical Home (PCMH) and the Chronic Care Model (CCM) are complementary clinical intervention frameworks that are commonly invoked to support better type 2 diabetes (T2DM) outcomes in primary care. Self-management Support (SMS) is a core component of both the PCMH and CCM, and fo...

What is the current status of trial NCT02834923?

This trial is currently completed. It is a NA study. The enrollment target is 725 participants. The study started on 2016-10. Estimated completion is 2020-12-20.

What conditions does trial NCT02834923 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.

What interventions are being tested in trial NCT02834923?

The interventions under investigation include: Enhanced Engagement Protocol for CTH (EE-CTH) (BEHAVIORAL), Connection to Health (CTH) (BEHAVIORAL).

Who is sponsoring clinical trial NCT02834923?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02834923 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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