The Management of Diabetes in Everyday Life Program

Diabetes Mellitus Clinical Trial

— MODEL  

Official title:

Improving Self-Care Decisions of Medically Underserved African-Americans With Uncontrolled Diabetes: Effectiveness of Patient-Driven Text Messaging Versus Health Coaching

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02957513
• Other study ID #: 16-04735-FB
• Secondary ID: SC15-1503-28336
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2019
• Source: University of Tennessee
• Contact: Cardella L Leak, MPH
• Phone: 9014482476
• Email: clleak[@]uthsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 646
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Diabetes Mellitus

Intervention

Behavioral:
• Text Messaging (TM)
As specified in the arm description above
• Health Coaching (HC)
As specified in the arm description above
• Enhanced Usual Care (EC)
As specified in the arm description above

Locations

Country	Name	City	State
United States	Covington Pike Primary Care, Methodist Le Bonheur Healthcare	Bartlett	Tennessee
United States	Tipton Family Medicine Center	Covington	Tennessee
United States	Hawkins Family Medicine	Holly Springs	Mississippi
United States	University of Tennessee Family Practice Center	Jackson	Tennessee
United States	Christ Community Health Center - Raleigh Health Center	Memphis	Tennessee
United States	Christ Community Health Services - Third Street Health Center	Memphis	Tennessee
United States	Christ Community Health Services, Broad Avenue Health Center	Memphis	Tennessee
United States	Eastmoreland Internal Medicine	Memphis	Tennessee
United States	Memphis Health Center	Memphis	Tennessee
United States	Midtown Internal Medicine, Methodist Le Bonheur Healthcare	Memphis	Tennessee
United States	Motley Internal Medicine, Methodist Le Bonheur Healthcare	Memphis	Tennessee
United States	Peabody Family Care, Methodist Le Bonheur Healthcare	Memphis	Tennessee
United States	PennMarc Internal Medicine, Methodist Le Bonheur Healthcare	Memphis	Tennessee
United States	Regional One Health	Memphis	Tennessee
United States	South Internal Medicine, Methodist Le Bonheur Healthcare	Memphis	Tennessee
United States	TriState Medical Group PLLC	Memphis	Tennessee
United States	UT Methodist Physicians, Eastmoreland Endocrinology	Memphis	Tennessee
United States	UT Methodist Physicians, South Endocrinology	Memphis	Tennessee
United States	Whitney Slade Internal Medicine, Methodist Le Bonheur Healthcare	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
University of Tennessee	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetes Self-Care Activities	The Revised Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) assesses DM self-care over the previous 7 days for 7 core behaviors: smoking, diet, exercise, blood sugar testing, foot care, smoking, and medication adherence (12 items)	1 year
Secondary	Diabetes-Specific Quality of Life	The Diabetes-39 has 5 domains: DM control, Anxiety and worry, Social burden, Sexual functioning, and Energy and mobility	1 year
Secondary	Primary Care Engagement	Selected National Health Interview Survey (NHIS) questions assess 3 primary domains: (a) Usual source of care when sick; (b) Usual source of preventive care; and (c) Delay in needed care	1 year
Secondary	Quality of Care	The Patient Assessment of Chronic Illness Care (PACIC) measures specific actions or qualities of care based on Chronic Care Model	1 year
Secondary	Average Blood Sugar (A1c)	The Hemoglobin A1c blood test assesses average blood sugar over the past 6 weeks to 3 months	1 year

External Links

•   PCORI Project Summary