Evaluating Outcomes for Ethnically Diverse Patients With Type 2 Diabetes Participating in a Diabetes Education Program (DSMES)

January 10, 2020 updated by: Hoag Memorial Hospital Presbyterian

Evaluating Patient Engagement and Other Outcomes for Ethnically Diverse Patients With Type 2 Diabetes Participating in a Structured, Physician Supported, Patient-centered Diabetes Education Program

The proposed study has been developed to evaluate patient, physician, and provider (educator) centered barriers to and facilitators for engaging in the Diabetes Self Management Education and Support (DSMES) and developing a patient-centered, physician supported DSMES program that could potentially address barriers shared by the patients and their healthcare professionals (Phase 1). The feasibility and efficacy of the newly developed program will be evaluated with an ethnically diverse cohort of 90 patients with type 2 diabetes (30 Caucasians, Asians, and Hispanics each) (Phase 2). A variety of outcomes including clinical, behavioral and psycho-social measures will be used to assess program acceptability and effectiveness.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Diabetes is a chronic and a progressive metabolic disorder which necessitates active patient involvement to effectively manage nutrition, physical activity, and medication for optimal outcomes. Self-management is a critical aspect of diabetes care and a variety of studies have established the need for people with diabetes to be knowledgeable about their condition and be actively involved in its management to effectively reduce the risk of future health complications and improve other outcomes. Diabetes self-management education and support (DSMES) can help patients effectively engage in and perform their diabetes-related self-care activities. However, only a small number of patients with diabetes participate in DSMES. A few studies in this area have highlighted both physician and patient-related factors that could affect the receipt of DSMES. Patients' involvement in a DSMES program continues to be largely prompted by a physician referral and it has been suggested that improving physician involvement in the DSMES process could enhance overall patient engagement and adherence to such programs.

As part of the proposed mixed methods study, in Phase 1, in-depth surveys (or interviews) will be undertaken with: (a) physicians caring for people with type 2 diabetes, (b) DSMES providers (e.g., certified diabetes educators, diabetes nurses, dietitians), and (b) patients with type 2 diabetes regarding their perception of diabetes education programs, barriers, and facilitators to engagement. Findings from Phase 1 will be shared with the education team at a diabetes center in a community hospital in Orange County, California to inform changes to their currently existing diabetes education curriculum to make it more patient-centered and improve physician engagement and support. As part of Phase 2, the newly developed program will be implemented with a diverse cohort of 90 patients with type 2 diabetes. Patient participation (attendance) in the DSMES process will be documented as a primary marker of patient engagement while their clinical and psycho-social outcomes will serve as secondary indicators. Among other outcomes, physician, educator, and patient satisfaction with the newly developed referral process will also be assessed as a measure of intervention acceptability and success.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • United States
    • California
      • Newport Beach, California, United States, 92663
        • Mary & Dick Allen Diabetes Center, Hoag Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients of White, Asian, or Hispanic origin (30 in each group) Fluent in English (for the White and Asian group) Fluent in Spanish (for the Hispanic group) Age > 18 years Physician referral for DSME/S Formal diagnosis of type 2 diabetes

Exclusion Criteria:

Current or planned pregnancy. Any medical or other condition that the investigator feels would interfere with study participation.

Mental incapacity precluding adequate understanding or cooperation. Potential participants who are imprisoned or hospitalized

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: DSMES Group
Patients with type 2 diabetes will undergo a diabetes education program (DSMES) and evaluated for outcomes before and after completing the program.
Behavioral: DSMES
It is primarily an educational intervention that is focused on assisting patients improve their management and coping with type 2 diabetes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Program completion
Time Frame: Approximately at 4 months from the start of the study.
Evaluate the rate of program completion in study participants
Approximately at 4 months from the start of the study.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: At baseline and repeated after approximately 4 months
Evaluated using HbA1c (blood test)
At baseline and repeated after approximately 4 months
Diabetes-specific quality of life
Time Frame: At baseline and repeated after approximately 4 months
Measure assessing diabetes-specific quality of life
At baseline and repeated after approximately 4 months
Diabetes-related distress
Time Frame: At baseline and repeated after approximately 4 months
Measure assessing diabetes-related distress or problem areas in diabetes
At baseline and repeated after approximately 4 months
Diabetes self-care
Time Frame: At baseline and repeated after approximately 4 months
Measure assessing diabetes-related self-care
At baseline and repeated after approximately 4 months
Diabetes-related self efficacy
Time Frame: At baseline and repeated after approximately 4 months
Measure assessing diabetes-related self-efficacy
At baseline and repeated after approximately 4 months
Patient and referring provider satisfaction
Time Frame: Approximately at 4 months from the start of the study.
Measures to assess patient and referring provider related satisfaction with the program.
Approximately at 4 months from the start of the study.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoag Memorial Hospital Presbyterian

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Harsimran Harsimran, PhD, Hoag Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 4, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 5, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 5, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RADC2018_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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