Controlling Hyperglycemia Among Minority Population (CHAMP)

Controlling Hyperglycemia Among Minority Population (CHAMP): A Randomized Controlled Trial of Two Diabetes Interventions for Underserved Communities

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Behavioral: Community health worker education; Behavioral: Cell phone text messaging

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.

• Study Type: Interventional
• Enrollment (Actual): 272
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60608
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Community Health Worker education; 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.	Behavioral: Community health worker education; Diabetes self-management education by community health workers
Experimental: Cell phone text messaging; 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.	Behavioral: Cell phone text messaging; Diabetes self-management education through cell phone text messaging
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change in diabetes knowledge test scores	Michigan Diabetes and Research Center Knowledge test	6 months
Mean change in diabetes self-efficacy scores	Perceived competence in diabetes scale	6 months
Mean change in diabetes distress scores	Problem areas in diabetes (PAID-5) scale	6 months
Mean change in participants' beliefs about using insulin scores	Insulin treatment appraisal (ITAS) scale	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	6 months
Percentage of participants who visited a physician due to a diabetes related follow-up	Self- reported	6 months

Collaborators and Investigators

• Sponsor: Sinai Health System
• Collaborators: Blue Cross Blue Shield

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: February 3, 2016
• First Submitted That Met QC Criteria: February 11, 2016
• First Posted (Estimate): February 12, 2016

Study Record Updates

• Last Update Posted (Actual): January 26, 2018
• Last Update Submitted That Met QC Criteria: January 24, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: minorities; A1C≥9%; economically disadvantaged
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: MSH15-46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO