Controlling Hyperglycemia Among Minority Population (CHAMP): A Randomized Controlled Trial of Two Diabetes Interventions for Underserved Communities
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- Sinai Health System
- Enrollment
- 272
- Locations
- 1
- Primary Endpoint
- Difference in Hemoglobin A1C (CHW vs. Control)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to compare the efficacy of three approaches in diabetes management: (1) community health worker (CHW) education; (2) text messaging; and (3) usual hospital-based care. The goal is to determine the most cost-effective method of diabetes management among an economically-disadvantaged, minority population.
Detailed Description
The CHAMP study will test the efficacy of two interventions designed to decrease uncontrolled hyperglycemia (defined as Hemoglobin-A1C (A1C) at or above 9%) among adults with diabetes. Patients from a safety-net hospital will be randomized into three groups: 1) a control group, 2) an intervention providing diabetes self-care text messages, or 3) an intervention using community health workers to provide diabetes education and linkage to care. Secondary objectives include increasing diabetes knowledge, improving diabetes self-management, and increasing use of primary care (i.e., make one visit to the physician in 6 months) among the intervention participants. A cost-effectiveness analysis will determine the most appropriate way to reduce the burden of uncontrolled diabetes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\*Hyperglycemia with A1C ≥9%
Exclusion Criteria
- •Lives greater than 20 miles driving distance from Mount Sinai Hospital
- •Pregnant women with gestational diabetes
- •Advanced end-organ complications due to diabetes that include: end-stage renal disease, stroke with paresis, Congestive Heart Failure (NYHA class III or IV), or other major end-organ complication of diabetes
- •Receiving treatment for a major psychiatric disorder (i.e. schizophrenia)
- •Unable to understand and give informed consent in either English or Spanish
- •Currently or previously participated in a diabetes research study
- •Family member currently enrolled in a diabetes research study
- •Previously received diabetes care related cell phone text messages
- •Unable to receive text messages 3-4 times per week
- •Living in a homeless shelter or temporary housing
Outcomes
Primary Outcomes
Difference in Hemoglobin A1C (CHW vs. Control)
Time Frame: 6 months
To assess whether there is a statistically significant difference in HbA1C level between CHW and control groups at 6 months follow-up.
Difference in Hemoglobin A1C (Text Message vs. Control)
Time Frame: 6 months
To assess whether there is a statistically significant difference in HbA1C level between text message and control groups at 6 months follow-up.
Secondary Outcomes
- Mean change in diabetes distress scores(6 months)
- Mean change in participants' beliefs about using insulin scores(6 months)
- Mean changes in diabetes self-care activities(6 months)
- Percentage of participants who visited a physician due to a diabetes related follow-up(6 months)
- Percentage change in diabetes knowledge test scores(6 months)
- Mean change in diabetes self-efficacy scores(6 months)