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

Primary Purpose

Type2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DSMES
Sponsored by
Hoag Memorial Hospital Presbyterian
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type2 Diabetes focused on measuring Diabetes education, Psychosocial management of diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mary & Dick Allen Diabetes Center, Hoag Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

DSMES Group

Arm Description

Patients with type 2 diabetes will undergo a diabetes education program (DSMES) and evaluated for outcomes before and after completing the program.

Outcomes

Primary Outcome Measures

Program completion
Evaluate the rate of program completion in study participants

Secondary Outcome Measures

Glycemic control
Evaluated using HbA1c (blood test)
Diabetes-specific quality of life
Measure assessing diabetes-specific quality of life
Diabetes-related distress
Measure assessing diabetes-related distress or problem areas in diabetes
Diabetes self-care
Measure assessing diabetes-related self-care
Diabetes-related self efficacy
Measure assessing diabetes-related self-efficacy
Patient and referring provider satisfaction
Measures to assess patient and referring provider related satisfaction with the program.

Full Information

First Posted
March 2, 2018
Last Updated
January 10, 2020
Sponsor
Hoag Memorial Hospital Presbyterian
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1. Study Identification

Unique Protocol Identification Number
NCT03464812
Brief Title
Evaluating Outcomes for Ethnically Diverse Patients With Type 2 Diabetes Participating in a Diabetes Education Program
Acronym
DSMES
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 4, 2017 (Actual)
Primary Completion Date
August 5, 2019 (Actual)
Study Completion Date
August 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoag Memorial Hospital Presbyterian

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes
Keywords
Diabetes education, Psychosocial management of diabetes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DSMES Group
Arm Type
Other
Arm Description
Patients with type 2 diabetes will undergo a diabetes education program (DSMES) and evaluated for outcomes before and after completing the program.
Intervention Type
Behavioral
Intervention Name(s)
DSMES
Intervention Description
It is primarily an educational intervention that is focused on assisting patients improve their management and coping with type 2 diabetes.
Primary Outcome Measure Information:
Title
Program completion
Description
Evaluate the rate of program completion in study participants
Time Frame
Approximately at 4 months from the start of the study.
Secondary Outcome Measure Information:
Title
Glycemic control
Description
Evaluated using HbA1c (blood test)
Time Frame
At baseline and repeated after approximately 4 months
Title
Diabetes-specific quality of life
Description
Measure assessing diabetes-specific quality of life
Time Frame
At baseline and repeated after approximately 4 months
Title
Diabetes-related distress
Description
Measure assessing diabetes-related distress or problem areas in diabetes
Time Frame
At baseline and repeated after approximately 4 months
Title
Diabetes self-care
Description
Measure assessing diabetes-related self-care
Time Frame
At baseline and repeated after approximately 4 months
Title
Diabetes-related self efficacy
Description
Measure assessing diabetes-related self-efficacy
Time Frame
At baseline and repeated after approximately 4 months
Title
Patient and referring provider satisfaction
Description
Measures to assess patient and referring provider related satisfaction with the program.
Time Frame
Approximately at 4 months from the start of the study.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harsimran Harsimran, PhD
Organizational Affiliation
Hoag Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mary & Dick Allen Diabetes Center, Hoag Hospital
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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