Controlling Hyperglycemia Among Minority Population

Diabetes Clinical Trial

— CHAMP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02681718
• Other study ID #: MSH15-46
• Status: Completed
• Phase: N/A
• First received: February 3, 2016
• Last updated: January 24, 2018
• Start date: January 2016
• Est. completion date: September 2017

Study information

• Verified date: January 2018
• Source: Sinai Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Hyperglycemia

Intervention

Behavioral:
• Community health worker education
Diabetes self-management education by community health workers
• Cell phone text messaging
Diabetes self-management education through cell phone text messaging

Locations

Country	Name	City	State
United States	Mount Sinai Hospital	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Sinai Health System	Blue Cross Blue Shield

Country where clinical trial is conducted

United States, 

Outcome

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