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Controlling Hyperglycemia Among Minority Population (CHAMP)

Primary Purpose

Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Community health worker education
Cell phone text messaging
Sponsored by
Sinai Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes focused on measuring A1C≥9%, minorities, economically disadvantaged

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Community Health Worker education

Cell phone text messaging

Control

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Percentage change in diabetes knowledge test scores
Michigan Diabetes and Research Center Knowledge test
Mean change in diabetes self-efficacy scores
Perceived competence in diabetes scale
Mean change in diabetes distress scores
Problem areas in diabetes (PAID-5) scale
Mean change in participants' beliefs about using insulin scores
Insulin treatment appraisal (ITAS) scale
Mean changes in diabetes self-care activities
Diabetes self-care activities include: diet, physical activity, self-monitoring of blood glucose, foot-care, and smoking
Percentage of participants who visited a physician due to a diabetes related follow-up
Self- reported

Full Information

First Posted
February 3, 2016
Last Updated
January 24, 2018
Sponsor
Sinai Health System
Collaborators
Blue Cross Blue Shield
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1. Study Identification

Unique Protocol Identification Number
NCT02681718
Brief Title
Controlling Hyperglycemia Among Minority Population
Acronym
CHAMP
Official Title
Controlling Hyperglycemia Among Minority Population (CHAMP): A Randomized Controlled Trial of Two Diabetes Interventions for Underserved Communities
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinai Health System
Collaborators
Blue Cross Blue Shield

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes
Keywords
A1C≥9%, minorities, economically disadvantaged

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
272 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Community Health Worker education
Arm Type
Experimental
Arm 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.
Arm Title
Cell phone text messaging
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Community health worker education
Intervention Description
Diabetes self-management education by community health workers
Intervention Type
Behavioral
Intervention Name(s)
Cell phone text messaging
Intervention Description
Diabetes self-management education through cell phone text messaging
Primary Outcome Measure Information:
Title
Difference in Hemoglobin A1C (CHW vs. Control)
Description
To assess whether there is a statistically significant difference in HbA1C level between CHW and control groups at 6 months follow-up.
Time Frame
6 months
Title
Difference in Hemoglobin A1C (Text Message vs. Control)
Description
To assess whether there is a statistically significant difference in HbA1C level between text message and control groups at 6 months follow-up.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percentage change in diabetes knowledge test scores
Description
Michigan Diabetes and Research Center Knowledge test
Time Frame
6 months
Title
Mean change in diabetes self-efficacy scores
Description
Perceived competence in diabetes scale
Time Frame
6 months
Title
Mean change in diabetes distress scores
Description
Problem areas in diabetes (PAID-5) scale
Time Frame
6 months
Title
Mean change in participants' beliefs about using insulin scores
Description
Insulin treatment appraisal (ITAS) scale
Time Frame
6 months
Title
Mean changes in diabetes self-care activities
Description
Diabetes self-care activities include: diet, physical activity, self-monitoring of blood glucose, foot-care, and smoking
Time Frame
6 months
Title
Percentage of participants who visited a physician due to a diabetes related follow-up
Description
Self- reported
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Mount Sinai Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Controlling Hyperglycemia Among Minority Population

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