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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03464812
Acronym
DSMES
Enrollment
48
Registered
2018-03-14
Start date
2017-08-04
Completion date
2019-08-05
Last updated
2020-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type2 Diabetes

Keywords

Diabetes education, Psychosocial management of diabetes

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.

Interventions

BEHAVIORALDSMES

It is primarily an educational intervention that is focused on assisting patients improve their management and coping with type 2 diabetes.

Sponsors

Hoag Memorial Hospital Presbyterian
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Program completionApproximately at 4 months from the start of the study.Evaluate the rate of program completion in study participants

Secondary

MeasureTime frameDescription
Diabetes-specific quality of lifeAt baseline and repeated after approximately 4 monthsMeasure assessing diabetes-specific quality of life
Diabetes-related distressAt baseline and repeated after approximately 4 monthsMeasure assessing diabetes-related distress or problem areas in diabetes
Glycemic controlAt baseline and repeated after approximately 4 monthsEvaluated using HbA1c (blood test)
Diabetes-related self efficacyAt baseline and repeated after approximately 4 monthsMeasure assessing diabetes-related self-efficacy
Patient and referring provider satisfactionApproximately at 4 months from the start of the study.Measures to assess patient and referring provider related satisfaction with the program.
Diabetes self-careAt baseline and repeated after approximately 4 monthsMeasure assessing diabetes-related self-care

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026