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The Management of Diabetes in Everyday Life Program (MODEL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02957513
Recruitment Status : Recruiting
First Posted : November 6, 2016
Last Update Posted : October 10, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of Tennessee

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Chronic Disease Behavioral: Text Messaging (TM) Behavioral: Health Coaching (HC) Behavioral: Enhanced Usual Care (EC) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 646 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Self-Care Decisions of Medically Underserved African-Americans With Uncontrolled Diabetes: Effectiveness of Patient-Driven Text Messaging Versus Health Coaching
Actual Study Start Date : November 1, 2016
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: Text Messaging (TM)
As specified in the arm description above

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.
Behavioral: Health Coaching (HC)
As specified in the arm description above

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.

Behavioral: Text Messaging (TM)
As specified in the arm description above

Behavioral: Health Coaching (HC)
As specified in the arm description above

Behavioral: Enhanced Usual Care (EC)
As specified in the arm description above




Primary Outcome Measures :
  1. Diabetes Self-Care Activities [ Time Frame: 1 year ]
    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)


Secondary Outcome Measures :
  1. Diabetes-Specific Quality of Life [ Time Frame: 1 year ]
    The Diabetes-39 has 5 domains: DM control, Anxiety and worry, Social burden, Sexual functioning, and Energy and mobility

  2. Primary Care Engagement [ Time Frame: 1 year ]
    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

  3. Quality of Care [ Time Frame: 1 year ]
    The Patient Assessment of Chronic Illness Care (PACIC) measures specific actions or qualities of care based on Chronic Care Model

  4. Average Blood Sugar (A1c) [ Time Frame: 1 year ]
    The Hemoglobin A1c blood test assesses average blood sugar over the past 6 weeks to 3 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957513


Contacts
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Contact: Cardella L Leak, MPH 9014482476 clleak@uthsc.edu
Contact: Lauren Haley, MA 9014484168 lhaley1@uthsc.edu

Locations
Show Show 19 study locations
Sponsors and Collaborators
University of Tennessee
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: James E Bailey, MD, MPH University of Tennessee Health Science Center
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT02957513    
Other Study ID Numbers: 16-04735-FB
SC15-1503-28336 ( Other Grant/Funding Number: PCORI )
First Posted: November 6, 2016    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data may be exported from the database system that houses study data in a variety of formats for sharing and/or analysis. At study completion, the investigators anticipate extracting all data from the system for sharing with other sources once appropriate governance and sharing restrictions have been addressed. Data dictionaries and associated metadata will be provided as needed upon request. Data can be shipped or mailed in approved, encrypted format or collected via SFTP (secure file transfer protocol) from our servers. The cost of allowing prospective investigators access to the de-identified data from this project will include IRB costs to review the application, salary support to cover staff time to review the concept proposal, submit documents to the IRB, and to establish password-protected and secured transfer application of the data. This cost is per application per investigator who wishes access granted to the de-identified data.
Keywords provided by University of Tennessee:
Diabetes
Uncontrolled
Chronic Disease
Chronic Conditions
Medically Underserved Areas
African Americans
Health Coaching
Health Education
Text Messaging
Text Messages
Mobile Health
Additional relevant MeSH terms:
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Diabetes Mellitus
Chronic Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Disease Attributes
Pathologic Processes