NCT02957513: MODEL

The Management of Diabetes in Everyday Life Program

Status unknown NA Last updated 10 October 2019

What this trial tests

NA trial testing Text Messaging (TM) in Diabetes Mellitus in 646 participants. Status unknown.

Timeline

1 November 2016

Primary endpoint
31 December 2020

31 December 2020

Quick facts

Lead sponsor	University of Tennessee
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	646
Start date	1 November 2016
Primary completion	31 December 2020
Estimated completion	31 December 2020
Sites	19 locations across United States

Drugs / interventions tested

• Text Messaging (TM)
• Health Coaching (HC)
• Enhanced Usual Care (EC)

Conditions studied

• Diabetes Mellitus — all drugs for Diabetes Mellitus →
• Chronic Disease — all drugs for Chronic Disease →

Sponsor

University of Tennessee

Who can join

18 and older, any sex, with Diabetes Mellitus or Chronic Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Gatwood J, Shuvo S, Ross A, Riordan C, et al · · 2020 · cited 14× · PMID 30794316 · DOI 10.1093/tbm/ibz024
2. 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.
   Bailey JE, Surbhi S, Gatwood J, Butterworth S, et al · · 2020 · cited 8× · PMID 32653539 · DOI 10.1016/j.cct.2020.106080
3. Use of Digital Health Technology in Heart Failure and Diabetes: a Scoping Review.
   Kallas D, Sandhu N, Gandilo C, Schleicher M, et al · · 2023 · cited 5× · PMID 35639339 · DOI 10.1007/s12265-022-10273-6
4. Comparative Effectiveness of Diabetes Self-Care Interventions in African-American Adults: A Three-Arm Randomized Controlled Trial.
   Bailey JE, Surbhi S, Gatwood J, Butterworth SW, et al · · 2026 · PMID 41116096 · DOI 10.1007/s11606-025-09882-z
5. Using preliminary data and prospective power analyses for mid-stream revision of projected group and subgroup sizes in pragmatic patient-centered outcomes research.
   Tolley EA, Surbhi S, Bailey JE. · · 2020 · PMID 33304950 · DOI 10.1016/j.dib.2020.106529