Controlling Hyperglycemia Among Minority Population
- Conditions
- Diabetes
- Registration Number
- NCT02681718
- Lead Sponsor
- Sinai Health System
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 272
*Hyperglycemia with A1C ≥9%
- 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
- Plans to travel outside of the United States for more than 3 months in next year
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Difference in Hemoglobin A1C (CHW vs. Control) 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) 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 Outcome Measures
Name Time Method Mean change in diabetes distress scores 6 months Problem areas in diabetes (PAID-5) scale
Mean change in participants' beliefs about using insulin scores 6 months Insulin treatment appraisal (ITAS) scale
Mean changes in diabetes self-care activities 6 months Diabetes self-care activities include: diet, physical activity, self-monitoring of blood glucose, foot-care, and smoking
Percentage of participants who visited a physician due to a diabetes related follow-up 6 months Self- reported
Percentage change in diabetes knowledge test scores 6 months Michigan Diabetes and Research Center Knowledge test
Mean change in diabetes self-efficacy scores 6 months Perceived competence in diabetes scale
Trial Locations
- Locations (1)
Mount Sinai Hospital
🇺🇸Chicago, Illinois, United States
Mount Sinai Hospital🇺🇸Chicago, Illinois, United States