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

Sponsor
Hoag Memorial Hospital Presbyterian (Other)
Overall Status
Completed
CT.gov ID
NCT03464812
Collaborator
(none)
48
1
1
24
2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: DSMES
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Aug 4, 2017
Actual Primary Completion Date :
Aug 5, 2019
Actual Study Completion Date :
Aug 5, 2019

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Program completion [Approximately at 4 months from the start of the study.]

    Evaluate the rate of program completion in study participants

Secondary Outcome Measures

  1. Glycemic control [At baseline and repeated after approximately 4 months]

    Evaluated using HbA1c (blood test)

  2. Diabetes-specific quality of life [At baseline and repeated after approximately 4 months]

    Measure assessing diabetes-specific quality of life

  3. Diabetes-related distress [At baseline and repeated after approximately 4 months]

    Measure assessing diabetes-related distress or problem areas in diabetes

  4. Diabetes self-care [At baseline and repeated after approximately 4 months]

    Measure assessing diabetes-related self-care

  5. Diabetes-related self efficacy [At baseline and repeated after approximately 4 months]

    Measure assessing diabetes-related self-efficacy

  6. Patient and referring provider satisfaction [Approximately at 4 months from the start of the study.]

    Measures to assess patient and referring provider related satisfaction with the program.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mary & Dick Allen Diabetes Center, Hoag Hospital Newport Beach California United States 92663

Sponsors and Collaborators

  • Hoag Memorial Hospital Presbyterian

Investigators

  • Principal Investigator: Harsimran Harsimran, PhD, Hoag Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoag Memorial Hospital Presbyterian
ClinicalTrials.gov Identifier:
NCT03464812
Other Study ID Numbers:
  • RADC2018_1
First Posted:
Mar 14, 2018
Last Update Posted:
Jan 14, 2020
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hoag Memorial Hospital Presbyterian
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 14, 2020