The Management of Diabetes in Everyday Life Program
The Management of Diabetes in Everyday Life Program
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.
Background and Significance: There is a critical need to determine the comparative
 effectiveness of text messaging (TM) and health coaching (HC) among African-Americans with
 uncontrolled diabetes and multiple chronic conditions living in medically underserved areas
 (MUA) and to identify which modality yields greater improvement in diabetes self-care at-risk
 urban and rural subpopulations. Although numerous recent studies demonstrate the
 effectiveness of either TM or HC in improving diabetes and other chronic disease self-care
 behaviors, and to the knowledge of the investigators no information is available regarding
 comparative effectiveness of these modalities in urban and rural subgroups. Prevalence of
 diabetes, related comorbidities, poverty, obesity, food insecurity, and tobacco use is higher
 in rural areas as compared with urban. Moreover, rural areas struggle to address these needs
 because of lower access to transportation, primary care, specialty care, diabetes education,
 and mental health resources. However, urban living has its own unique set of
 problems-including increased stress and fear for one's physical safety-that may impact the
 comparative effectiveness of HC and TM. Although there are HC studies that show effectiveness
 in interventions either in rural or urban areas, there are no HC studies of which the
 investigators are aware that specifically examine the differences in U.S. rural and urban
 participants in regards to engagement rates and clinical outcomes from a health coaching
 intervention. Similarly, telemedicine and mobile health approaches have been particularly
 advocated for rural populations yet little evidence supports their comparative benefit. The
 lack of comparative effectiveness of text messaging and health coaching for diabetes
 self-care in vulnerable urban and rural subgroups represents a critical gap in research that
 the study is designed to directly address. The study will compare both strategies with
 enhanced usual care (EC) with diabetes educational materials.

 Study Aims: As a result, this research will use a pragmatic randomized trial to determine the
 comparative effectiveness of patient-driven TM versus HC versus EC for African-American
 adults with uncontrolled diabetes and multiple chronic conditions in MUA with an emphasis on
 identifying and quantifying important interactions between key baseline characteristics and
 treatment arm. Specific aims include: Aim 1-Quantify the effectiveness of TM, HC, and EC in
 improving the primary outcome measures (diabetes self-care activities related to general
 diet, exercise and medication adherence); Aim 2-Determine the contributions of six key,
 baseline patient characteristics: 1) urban vs. rural residence, 2) health literacy, 3)
 medical complexity, 4) social complexity, 5) smart vs. cell phone ownership, and 6) age, to
 the comparative effectiveness of TM, HC, and EC; and Aim 3-Quantify the effectiveness of TM,
 HC, and EC in improving secondary outcomes of average blood sugar, quality of life, and
 primary care engagement. The long-term objectives are to disseminate and foster
 implementation of the results of this research in MUA nationwide to improve critical
 self-care supports in primary care for our most vulnerable populations.

 Overall study design: Pragmatic randomized clinical trial.

 Main components of the intervention and comparator(s): The study will test two critical
 strategies for patient engagement that may lead to substantive improvements in the quality of
 care and outcomes most important to vulnerable patients with diabetes: 1) patient-driven TM,
 and 2) patient-driven HC. The two parallel primary care-based and patient-driven study
 interventions (i.e. TM and HC) have been designed to provide approximately the same content,
 but with two alternative delivery mechanisms. TM will incorporate supportive cognitive
 behavioral strategies to encourage improved diabetes self-care decisions and will be tailored
 based on participant demographics, health literacy, preferences, treatment self-regulation,
 perceived competency and reported barriers to self-care. Motivational interviewing focused HC
 will aim to meet with participants for individual HC sessions bi-monthly the first 2 months
 (Intensive Phase-4 sessions following randomization) followed by monthly for remaining 8
 months (12 sessions total) to provide support regarding diet/weight loss, physical activity,
 and medication adherence tailored according to patient-identified health goals. Both
 strategies will be compared with EC with diabetes educational materials.

 Study population: For the main comparative effectiveness analysis (Aim 1) the total sample
 size (after dropouts) is N=800 with 40% randomized to the TM arm (N1=320), 40% to the HC arm
 (N2=320), and 20% to the EC arm (N3 = 160). Participants include African-American adults,
 ages 35-75, with uncontrolled diabetes and multiple chronic conditions, living in medically
 underserved communities in the MidSouth who have a cell phone or smart phone with texting
 capability and complete a two-week run-in period demonstrating responsiveness to TM.

 Primary/secondary outcomes: The primary outcome measures assessing effectiveness include:
 three (out of six total) subscales of the revised Summary of Diabetes Self-Care Activities
 questionnaire assessing general diet, exercise, and medication adherence. Secondary outcomes
 include: diabetes-specific quality of life using the Diabetes-39, primary care engagement
 using National Health Interview Survey questions regarding delayed needed care, and average
 blood sugar (A1c) obtained from medical records and reported in the DWPC-R.

 Analytic methods: For Aim 1, in the context of repeated measures ANOVA, using t-tests within
 arm to detect change from baseline to 12-months (Follow-up 3), power exceeds 0.9 for all
 primary outcomes. For Aim 2, six analyses will assess heterogeneity of treatment effects by
 evaluating the interaction of each key, dichotomized, baseline characteristic with treatment
 arm, estimating means and standard errors of six subclasses, and within each characteristic
 (e.g. low or high health literacy) testing for differences between TM and HC, TM and EC, and
 HC and TM. Analyses for Aim 3 will be conducted as described above for Aim 1.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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.