Diabetes
Conditions
Keywords
A1C≥9%, minorities, economically disadvantaged
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.
Interventions
BEHAVIORALCommunity health worker education
Diabetes self-management education by community health workers
BEHAVIORALCell phone text messaging
Diabetes self-management education through cell phone text messaging
Sponsors
Blue Cross Blue Shield
Sinai Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Hemoglobin A1C (CHW vs. Control) | 6 months | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean change in diabetes distress scores | 6 months | Problem areas in diabetes (PAID-5) scale |
| Mean change in participants' beliefs about using insulin scores | 6 months | Insulin treatment appraisal (ITAS) scale |
| Percentage change in diabetes knowledge test scores | 6 months | Michigan Diabetes and Research Center Knowledge test |
| Percentage of participants who visited a physician due to a diabetes related follow-up | 6 months | Self- reported |
| Mean changes in diabetes self-care activities | 6 months | Diabetes self-care activities include: diet, physical activity, self-monitoring of blood glucose, foot-care, and smoking |
| Mean change in diabetes self-efficacy scores | 6 months | Perceived competence in diabetes scale |
Countries
United States
Outcome results
None listed