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Completed

NCT Number: NCT02681718

Controlling Hyperglycemia Among Minority Population

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

Chicago, Illinois, 60608, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Community health worker education

Behavioral

Diabetes self-management education by community health workers

Cell phone text messaging

Behavioral

Diabetes self-management education through cell phone text messaging

Primary outcomes

  1. Difference in Hemoglobin A1C (CHW vs. Control)

    Time frame: 6 months

    To assess whether there is a statistically significant difference in HbA1C level between CHW and control groups at 6 months follow-up.

  2. Difference in Hemoglobin A1C (Text Message vs. Control)

    Time frame: 6 months

    To assess whether there is a statistically significant difference in HbA1C level between text message and control groups at 6 months follow-up.

Secondary outcomes

  1. Percentage change in diabetes knowledge test scores

    Time frame: 6 months

    Michigan Diabetes and Research Center Knowledge test

  2. Mean change in diabetes self-efficacy scores

    Time frame: 6 months

    Perceived competence in diabetes scale

  3. Mean change in diabetes distress scores

    Time frame: 6 months

    Problem areas in diabetes (PAID-5) scale

  4. Mean change in participants' beliefs about using insulin scores

    Time frame: 6 months

    Insulin treatment appraisal (ITAS) scale

  5. Mean changes in diabetes self-care activities

    Time frame: 6 months

    Diabetes self-care activities include: diet, physical activity, self-monitoring of blood glucose, foot-care, and smoking

  6. Percentage of participants who visited a physician due to a diabetes related follow-up

    Time frame: 6 months

    Self- reported

Sponsors and collaborators

Lead sponsor

Sinai Health System

Other

Collaborators

  • Blue Cross Blue Shield

Registry information

Official study title

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

Acronym: CHAMP

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 12, 2016
Registry last updated
Jan 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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