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Clinical Trials/NCT03464812
NCT03464812
Completed
Not Applicable

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

Hoag Memorial Hospital Presbyterian1 site in 1 country48 target enrollmentAugust 4, 2017
ConditionsType2 Diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type2 Diabetes
Sponsor
Hoag Memorial Hospital Presbyterian
Enrollment
48
Locations
1
Primary Endpoint
Program completion
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 4, 2017
End Date
August 5, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Program completion

Time Frame: Approximately at 4 months from the start of the study.

Evaluate the rate of program completion in study participants

Secondary Outcomes

  • Diabetes-related self efficacy(At baseline and repeated after approximately 4 months)
  • Glycemic control(At baseline and repeated after approximately 4 months)
  • Diabetes-specific quality of life(At baseline and repeated after approximately 4 months)
  • Diabetes-related distress(At baseline and repeated after approximately 4 months)
  • Diabetes self-care(At baseline and repeated after approximately 4 months)
  • Patient and referring provider satisfaction(Approximately at 4 months from the start of the study.)

Study Sites (1)

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