Clinical trial NCT02957513: The Management of Diabetes in Everyday Life Program
Official title: Improving Self-Care Decisions of Medically Underserved African-Americans With Uncontrolled Diabetes: Effectiveness of Patient-Driven Text Messaging Versus Health Coaching
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Chronic Disease
Keywords: Diabetes
Uncontrolled
Chronic Disease
Chronic Conditions
Medically Underserved Areas
African Americans
Health Coaching
Health Education
Text Messaging
Text Messages
Mobile Health
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2016-11-06
Enrollment: 646
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diabetes Self-Care Activities
timeFrame: 1 year
Secondary outcomes:
measure: Diabetes-Specific Quality of Life
timeFrame: 1 year
measure: Primary Care Engagement
timeFrame: 1 year
measure: Quality of Care
timeFrame: 1 year
measure: Average Blood Sugar (A1c)
timeFrame: 1 year
Other outcomes:
Locations:
city: Holly Springs
country: United States
facility: Hawkins Family Medicine
state: Mississippi
city: Bartlett
country: United States
facility: Covington Pike Primary Care, Methodist Le Bonheur Healthcare
state: Tennessee
city: Covington
country: United States
facility: Tipton Family Medicine Center
state: Tennessee
city: Jackson
country: United States
facility: University of Tennessee Family Practice Center
state: Tennessee
city: Memphis
country: United States
facility: Eastmoreland Internal Medicine
state: Tennessee
city: Memphis
country: United States
facility: Midtown Internal Medicine, Methodist Le Bonheur Healthcare
state: Tennessee
city: Memphis
country: United States
facility: Peabody Family Care, Methodist Le Bonheur Healthcare
state: Tennessee
city: Memphis
country: United States
facility: UT Methodist Physicians, Eastmoreland Endocrinology
state: Tennessee
city: Memphis
country: United States
facility: Christ Community Health Services - Third Street Health Center
state: Tennessee
city: Memphis
country: United States
facility: TriState Medical Group PLLC
state: Tennessee
city: Memphis
country: United States
facility: Motley Internal Medicine, Methodist Le Bonheur Healthcare
state: Tennessee
city: Memphis
country: United States
facility: South Internal Medicine, Methodist Le Bonheur Healthcare
state: Tennessee
city: Memphis
country: United States
facility: UT Methodist Physicians, South Endocrinology
state: Tennessee
city: Memphis
country: United States
facility: PennMarc Internal Medicine, Methodist Le Bonheur Healthcare
state: Tennessee
city: Memphis
country: United States
facility: Christ Community Health Services, Broad Avenue Health Center
state: Tennessee
city: Memphis
country: United States
facility: Memphis Health Center
state: Tennessee
city: Memphis
country: United States
facility: Christ Community Health Center - Raleigh Health Center
state: Tennessee
city: Memphis
country: United States
facility: Whitney Slade Internal Medicine, Methodist Le Bonheur Healthcare
state: Tennessee
city: Memphis
country: United States
facility: Regional One Health
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: James E Bailey, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tolley EA, Surbhi S, Bailey JE. Using preliminary data and prospective power analyses for mid-stream revision of projected group and subgroup sizes in pragmatic patient-centered outcomes research. Data Brief. 2020 Nov 17;33:106529. doi: 10.1016/j.dib.2020.106529. eCollection 2020 Dec.
citation: Bailey JE, Surbhi S, Gatwood J, Butterworth S, Coday M, Shuvo SA, Dashputre AA, Brooks IM, Binkley BL, Riordan CJ, Steinberg HO, Gutierrez ML, Haley LE, Leak CL, Tolley EA. The management of diabetes in everyday life study: Design and methods for a pragmatic randomized controlled trial comparing the effectiveness of text messaging versus health coaching. Contemp Clin Trials. 2020 Sep;96:106080. doi: 10.1016/j.cct.2020.106080. Epub 2020 Jul 9.
citation: Gatwood J, Shuvo S, Ross A, Riordan C, Smith P, Gutierrez ML, Coday M, Bailey J. The Management of Diabetes in Everyday Life (MODEL) program: development of a tailored text message intervention to improve diabetes self-care activities among underserved African-American adults. Transl Behav Med. 2020 Feb 3;10(1):204-212. doi: 10.1093/tbm/ibz024.