Clinical Trials Directory

Trials / Completed

CompletedNCT02681718

Controlling Hyperglycemia Among Minority Population

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
272 (actual)
Sponsor
Sinai Health System · Academic / Other
Sex
All
Age
18 Years – 64 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCommunity health worker educationDiabetes self-management education by community health workers
BEHAVIORALCell phone text messagingDiabetes self-management education through cell phone text messaging

Timeline

Start date
2016-01-01
Primary completion
2017-09-01
Completion
2017-09-01
First posted
2016-02-12
Last updated
2018-01-26

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02681718. Inclusion in this directory is not an endorsement.