Clinical trial NCT02681718: Controlling Hyperglycemia Among Minority Population
Official title: Controlling Hyperglycemia Among Minority Population (CHAMP): A Randomized Controlled Trial of Two Diabetes Interventions for Underserved Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: A1C≥9%
minorities
economically disadvantaged
Lead sponsor: Sinai Health System
Sponsor class: OTHER
Collaborators: name: Blue Cross Blue Shield
First posted: 2016-02-12
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in Hemoglobin A1C (CHW vs. Control)
timeFrame: 6 months
measure: Difference in Hemoglobin A1C (Text Message vs. Control)
timeFrame: 6 months
Secondary outcomes:
measure: Percentage change in diabetes knowledge test scores
timeFrame: 6 months
measure: Mean change in diabetes self-efficacy scores
timeFrame: 6 months
measure: Mean change in diabetes distress scores
timeFrame: 6 months
measure: Mean change in participants' beliefs about using insulin scores
timeFrame: 6 months
measure: Mean changes in diabetes self-care activities
timeFrame: 6 months
measure: Percentage of participants who visited a physician due to a diabetes related follow-up
timeFrame: 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Mount Sinai Hospital
state: Illinois
Study officials:
References: