Controlling Hyperglycemia Among Minority Population

Sinai Health System272 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

272

Conditions

Diabetes

Interventions

Community health worker educationBEHAVIORAL

Diabetes self-management education by community health workers

Cell phone text messagingBEHAVIORAL

Diabetes self-management education through cell phone text messaging

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 * Plans to travel outside of the United States for more than 3 months in next year

Locations (1)

Mount Sinai Hospital

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Difference in Hemoglobin A1C (CHW vs. Control)

To assess whether there is a statistically significant difference in HbA1C level between CHW and control groups at 6 months follow-up.

Time frame: 6 months

Difference in Hemoglobin A1C (Text Message vs. Control)

To assess whether there is a statistically significant difference in HbA1C level between text message and control groups at 6 months follow-up.

Time frame: 6 months

Secondary Outcomes

Percentage change in diabetes knowledge test scores

Michigan Diabetes and Research Center Knowledge test

Time frame: 6 months

Mean change in diabetes self-efficacy scores

Perceived competence in diabetes scale

Time frame: 6 months

Mean change in diabetes distress scores

Problem areas in diabetes (PAID-5) scale

Time frame: 6 months

Mean change in participants' beliefs about using insulin scores

Insulin treatment appraisal (ITAS) scale

Time frame: 6 months

Mean changes in diabetes self-care activities

Diabetes self-care activities include: diet, physical activity, self-monitoring of blood glucose, foot-care, and smoking

Time frame: 6 months

Percentage of participants who visited a physician due to a diabetes related follow-up

Data from ClinicalTrials.gov

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