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

NCT03464812 | Completed

• 1 other identifier: RADC2018_1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes

Keywords

Diabetes education; Psychosocial management of diabetes

Outcome Measures

Primary Outcomes (1)

• Program completion

  Evaluate the rate of program completion in study participants

  Approximately at 4 months from the start of the study.

Secondary Outcomes (6)

• 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

• Diabetes-related self efficacy

  At baseline and repeated after approximately 4 months

Study Arms (1)

DSMES Group

OTHER

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

Behavioral: DSMES

Interventions

DSMES BEHAVIORAL

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

DSMES Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoag Memorial Hospital Presbyterian: lead

Study Sites (1)

Mary & Dick Allen Diabetes Center, Hoag Hospital

Newport Beach, California, 92663, United States

Location

Study Officials

• Harsimran Harsimran, PhD

  Hoag Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 14, 2018
• Study Start: August 4, 2017
• Primary Completion: August 5, 2019
• Study Completion: August 5, 2019
• Last Updated: January 14, 2020

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)