Controlling Hyperglycemia Among Minority Population (CHAMP)

Sinai Health System

Status: Completed

Conditions: Diabetes

Treatments: Behavioral: Community health worker education; Behavioral: Cell phone text messaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02681718

MSH15-46

Details and patient eligibility

About

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.

Full 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.

Enrollment: 272 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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272 participants in 3 patient groups

Community Health Worker education

Experimental group

Description:

During a six-month intervention period, the CHWs will conduct six home-based visitations and provide individualized diabetes education using an intensive diabetes lifestyle curriculum called Diabetes Learning Circle (DLC), developed and used by the Sinai Diabetes Education Program. At each visit, lasting for approximately one hour, the participants will be motivated to set SMART behavioral goals for diabetes self-management. At each visit after the initial visit, CHWs will follow-up with each participant to check their progress on their behavioral SMART goals. In addition, the CHWs will conduct intermittent phone calls (at least one monthly) and home visits as needed.

Treatment:

Behavioral: Community health worker education

Cell phone text messaging

Experimental group

Description:

The participants in the text messaging group will receive weekly text messages through CareMessage. Each participant will receive 3-4 text messages per week for 6 months.

Treatment:

Behavioral: Cell phone text messaging

Control

No Intervention group

Description:

The participants in the control group will receive education as determined by the hospital's diabetes educator, dietitian, physician, or the participant's managed care provider. No additional education will be provided by the research team.