Recruiting

Diabetes Management

Sponsor:

University of Tennessee

Code:

NCT02957513

Conditions

Diabetes Mellitus

Chronic Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Text Messaging (TM)

Health Coaching (HC)

Enhanced Usual Care (EC)

Study Details

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.

Conditions

Diabetes Mellitus

Chronic Disease

Study ID

NCT02957513

Start date

Nov 1, 2016

Status verified date

Jul, 2019

Completion date

Dec 31, 2020

Anticipated

Primary completion date

Dec 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

646 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Text Messaging (TM)

The TM intervention will use an extensive text message library focused on 3 key behavioral areas (diet, exercise, and medication adherence). The TM intervention will incorporate supportive cognitive behavioral strategies such as goal setting, positive reinforcement, self-talk and dealing with barriers to change. Messages will encourage social interaction (social support, problem-solving, and feedback), self-monitoring of diet and exercise, diet modification, physical activity advice and prompting and basic self- regulatory skills. Messages will be tailored based on participant demographics, health literacy, and preferences.

experimental: Health Coaching (HC)

The HC intervention will place emphasis on the coach establishing rapport with the participant and assessing and establishing their initial goals using motivational interviewing, HC program goals, plans for future individual sessions. A written copy of personal health goals will be given to patients at the end of the first session. Coaches will aim to meet with participants for individual HC sessions bi-monthly the first 2-3 months followed by monthly for 8 - 9 months to provide information and support regarding health habits focusing sessions on areas related to patient-identified health goals, needs, and barriers to change. Sessions can occur in person or by phone based on patient preference.

active comparator: Enhanced Usual Care (EC)

All participants in all 3 study arms (TM, HC, and EC) will receive enhanced usual care. Usual care in the participating practices will be supplemented through the following key EC resources:

A. Patient-focused Resources including: 1) MODEL Program Toolkit, and 2) low literacy diabetes educational materials.

B. Availability of diabetes support services including: 1) peer group support sessions, 2) diabetes education, 3) MyDiabetesCenter.org resources, and 4) Diabetes Coalition education hub resources.

C. Practice-focused components including: 1) practice training/continuing medical education, and 2) reporting of diabetes performance measures.

Interventions

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

Primary outcome measure

  • Diabetes Self-Care Activities [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

Covington Pike Primary Care, Methodist Le Bonheur Healthcare

Recruiting

Bartlett, Tennessee, United States, 38135

Contacts

University of Tennessee Family Practice Center

Recruiting

Jackson, Tennessee, United States, 38301

Contacts

Gregg Mitchell, MD

gemitchell@uthsc.edu

Eastmoreland Internal Medicine

Recruiting

Memphis, Tennessee, United States, 38104

Contacts

Midtown Internal Medicine, Methodist Le Bonheur Healthcare

Recruiting

Memphis, Tennessee, United States, 38104

Contacts

Peabody Family Care, Methodist Le Bonheur Healthcare

Recruiting

Memphis, Tennessee, United States, 38104

Contacts

UT Methodist Physicians, Eastmoreland Endocrinology

Recruiting

Memphis, Tennessee, United States, 38104

Contacts

Keith Paden

901-272-7797

Christ Community Health Services - Third Street Health Center

Recruiting

Memphis, Tennessee, United States, 38109

Contacts

Motley Internal Medicine, Methodist Le Bonheur Healthcare

Recruiting

Memphis, Tennessee, United States, 38116

Contacts

South Internal Medicine, Methodist Le Bonheur Healthcare

Recruiting

Memphis, Tennessee, United States, 38116

Contacts

UT Methodist Physicians, South Endocrinology

Recruiting

Memphis, Tennessee, United States, 38116

Contacts

PennMarc Internal Medicine, Methodist Le Bonheur Healthcare

Recruiting

Memphis, Tennessee, United States, 38119

Contacts

Paul Katz, MD

901-525-3086

Christ Community Health Services, Broad Avenue Health Center

Recruiting

Memphis, Tennessee, United States, 38122

Contacts

Memphis Health Center

Recruiting

Memphis, Tennessee, United States, 38126

Contacts

Barbara Williams, PhD

bwilliams1@mphshc.org

Christ Community Health Center - Raleigh Health Center

Recruiting

Memphis, Tennessee, United States, 38128

Contacts

Whitney Slade Internal Medicine, Methodist Le Bonheur Healthcare

Recruiting

Memphis, Tennessee, United States, 38128

Contacts

Angela Waterbury

Angela.Waterbury@mlh.org

Regional One Health

Recruiting

Memphis, Tennessee, United States, 38163

Contacts

More Information

Sponsor

University of Tennessee

Last update posted

Oct 10, 2019

Last verified

Jul, 2019

Keywords

  • Diabetes
  • Uncontrolled
  • Chronic Disease
  • Chronic Conditions
  • Medically Underserved Areas
  • African Americans
  • Health Coaching
  • Health Education
  • Text Messaging
  • Text Messages
  • Mobile Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Tennessee on 2019-10-10.