Type2 Diabetes Clinical Trial
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
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03239366 -
A Study to Evaluate the Effect of BioK+ 50B® on Glycemic Control in a Type 2 Diabetes Population
|
Phase 2 | |
Completed |
NCT04597229 -
Efficacy of Multigrain Supplementation in Type II Diabetes Mellitus
|
N/A | |
Completed |
NCT03623139 -
Effects of Basic Carbohydrate Counting Versus Standard Outpatient Nutritional Education in Type 2 Diabetes
|
N/A | |
Active, not recruiting |
NCT04599920 -
Effects of Replacing Red Meat With Legumes on Biomarkers of Chronic Diseases in Healthy Men (Leg4Life)
|
N/A | |
Active, not recruiting |
NCT03422471 -
Hypoglycemia and Autonomic Nervous System Function- B2
|
N/A | |
Completed |
NCT04382521 -
A Text Message Intervention to Promote Health Behaviors in Cardiac Risk Conditions
|
N/A | |
Recruiting |
NCT04564391 -
Whey or Casein - Liver Fat Reduction and Metabolic Improvement by Fast vs. Slow Proteins
|
N/A | |
Recruiting |
NCT03458715 -
The Efficacy of Sodium-glucose Co-transporter 2 Inhibitor or Dipeptidyl Peptidase-4 Inhibitor in Type 2 Diabetes Patients With Premix Insulin
|
Phase 4 | |
Terminated |
NCT03278236 -
Does Time Restricted Feeding Improve Glycaemic Control in Overweight Men?
|
N/A | |
Completed |
NCT02974504 -
Phase IV Clinical Trial to Investigate the Effect on Blood Glucose of Evogliptin in Patients With Type 2 Diabetes(EVERGREEN)
|
Phase 4 | |
Completed |
NCT05053828 -
Type 2 Diabetes With Antiplatelet Drugs
|
||
Not yet recruiting |
NCT03659383 -
The Exploration of Optimal Treatment Scheme in Patients With Type 2 Diabetes Inadequately Controlled With Glargine
|
Phase 4 | |
Completed |
NCT03542240 -
Effects of Curcumin Supplementation on Gut Barrier Function in Patients With Metabolic Syndrome
|
N/A | |
Completed |
NCT03657537 -
Effects of Ketone Bodies on Cognition in Type 2 Diabetes
|
Phase 1 | |
Completed |
NCT03979768 -
Risk Assessment of Type 2 Diabetes in Pharmacies
|
N/A | |
Completed |
NCT03614039 -
Effect of Probiotic and Smectite Gel on NAFLD
|
N/A | |
Active, not recruiting |
NCT04994288 -
A Study of Efficacy and Safety of Supaglutide in Type 2 Diabetes Patients
|
Phase 2/Phase 3 | |
Completed |
NCT03290768 -
Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics - (Protocol 3)
|
N/A | |
Enrolling by invitation |
NCT04088851 -
"The Role of the Liver for Interorgan Metabolic Crosstalk in Type 2 Diabetes"
|
N/A | |
Completed |
NCT03643783 -
Impact of Plasma Soluble Prorenin Receptor in Obese and Type 2 Diabetic Patients
|