The Management of Diabetes in Everyday Life Program
Status unconfirmed · Not applicable
Conditions studied: Diabetes Mellitus, Chronic Disease
In brief
The overall goal of this study is to compare how well motivational messages (text messages from the doctor's office), diabetes health coaches, and enhanced usual care with diabetes education materials (provided at the doctor's office) work to help African-American adults with uncontrolled diabetes improve their diabetes self-care decisions. Self-care is difficult when you have diabetes, especially when patients have other medical conditions, their diabetes is uncontrolled, and when they live in an area without many primary care doctors. Many studies have show that encouraging text messages from the doctor's office and health coaches can help people take better care of themselves. But before primary care clinics around the country start trying to send texts, hire health coaches, or provide additional educational materials it is critical for them to know which approach is more likely to help. This study will assign African-American diabetics to either text messages, health coaches, or enhanced care to find out which one works better. The investigators especially want to find out if one works better for people at highest risk. Lastly, the investigators want to find out if messages or coaches help people improve their blood sugar, quality of life, and their feelings about primary care. The study will test messages, coaches, and enhanced care side by side in primary care doctors' offices. The messaging and coaching programs will give patients pretty much the same information, but in different ways. The text messages will be written carefully based on each patient's needs and interests. The coaches will be trained in how to help people get motivated and work to reach their health goals. This study will include 646 African-American adults, ages 18 and above, with uncontrolled diabetes and one or more additional chronic condition, living in medically underserved communities. People will have to have a cell phone or smart phone with texting capability and be able to use it to participate. 258 participants will get messages, 258 will get coaches, and 130 will receive enhanced care. The investigators will be able to tell if messages and coaches work by seeing if people improve their diabetes self-care decisions, and if their blood sugar, quality of life, and feelings about primary care get better. The long-term study goal is to get primary care clinics all over the country to start using motivational messages or health coaches if they work well.
Key facts
- Study ID
- NCT02957513
- Run by
- University of Tennessee
- People needed
- 646
- Starts
- 2016-11-01
- Expected to finish
- 2020-12-31
- Last updated by the study team
- 2019-10-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- self-identified African-American adults
- diagnosis of uncontrolled diabetes (HbA1C > 8)
- have at least one other of 13 chronic health conditions (hypertension, congestive heart failure, coronary artery disease, cardiac arrhythmias, hyperlipidemia, stroke, arthritis, asthma, cancer, chronic kidney disease, chronic obstructive pulmonary disease, depression, and osteoporosis and excluding dementia)) using the CMS ICD-9-CM-based definitions
- is receiving or will receive care at one of our identified clinical sites
- has a cell phone or smart phone with texting and voicemail capabilities
- is not planning to move from the area in the next year
- is able to provide informed consent
- is English speaking
- completes a two-week run-in period for text message and voice message use
You may not qualify if…
- inability to understand consent procedures
- Pregnant
- presence of an unstable psychiatric condition or dementia
- perceived unwillingness or inability to participate
- inability to successfully complete the text message and voice message screening test
- Plans to move from the area and change primary care physicians in the next year.
- Diagnosis of severe depression in the last six months
- Individuals with cognitive impairment will be excluded if they experience difficulty either understanding, following directions, or communicating clearly with program staff. Individuals will be excluded if they exhibit uncontrolled psychiatric symptoms and/or behaviors that may present a danger to program staff or to the study participants themselves.
Where it is running
- Christ Community Health Center - Raleigh Health Center — Memphis, Tennessee, United States (enrolling)
- Whitney Slade Internal Medicine, Methodist Le Bonheur Healthcare — Memphis, Tennessee, United States (enrolling)
- Regional One Health — Memphis, Tennessee, United States (enrolling)
- University of Tennessee Family Practice Center — Jackson, Tennessee, United States (enrolling)
- Eastmoreland Internal Medicine — Memphis, Tennessee, United States (enrolling)
- Midtown Internal Medicine, Methodist Le Bonheur Healthcare — Memphis, Tennessee, United States (enrolling)
- Peabody Family Care, Methodist Le Bonheur Healthcare — Memphis, Tennessee, United States (enrolling)
- UT Methodist Physicians, Eastmoreland Endocrinology — Memphis, Tennessee, United States (enrolling)
- Christ Community Health Services - Third Street Health Center — Memphis, Tennessee, United States (enrolling)
- Covington Pike Primary Care, Methodist Le Bonheur Healthcare — Bartlett, Tennessee, United States (enrolling)
- Motley Internal Medicine, Methodist Le Bonheur Healthcare — Memphis, Tennessee, United States (enrolling)
- South Internal Medicine, Methodist Le Bonheur Healthcare — Memphis, Tennessee, United States (enrolling)
- UT Methodist Physicians, South Endocrinology — Memphis, Tennessee, United States (enrolling)
- PennMarc Internal Medicine, Methodist Le Bonheur Healthcare — Memphis, Tennessee, United States (enrolling)
- Christ Community Health Services, Broad Avenue Health Center — Memphis, Tennessee, United States (enrolling)
- Memphis Health Center — Memphis, Tennessee, United States (enrolling)
- TriState Medical Group PLLC — Memphis, Tennessee, United States
- Tipton Family Medicine Center — Covington, Tennessee, United States
- Hawkins Family Medicine — Holly Springs, Mississippi, United States
Full record on ClinicalTrials.gov
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