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Completed

NCT Number: NCT03487692

Medical Care, Education, Social Support, And Goal-setting to Empower Self-management for Diabetes

Diabetes group visits, shared appointments where patients receive self-management education in a group setting and have a medical visit, are a promising way to deliver high quality diabetes care. Group visits can improve glycemic control and decrease healthcare utilization. To date, no studies have systematically implemented a diabetes group visit intervention in a network of U.S. community health centers. The University of Chicago is partnering with Midwest Clinicians' Network (MWCN), a member organization of 130 health centers across ten Midwestern states. Approximately half of all Federally Qualified Health Centers in this region are affiliated with MWCN. The objectives of the study are [1] providers and staff at 20 health centers will have the requisite knowledge, skills, and motivation to implement a diabetes group visit plus text messaging intervention at their sites; [2] changes in diabetes processes of care; knowledge, attitudes, and skills for diabetes self-management; clinical outcomes; and health care utilization for patients participating in the diabetes group visit program will be evaluated; and [3] the diabetes group visit program will be available for dissemination among and use by health centers and healthcare providers at the local, state, regional, and national levels.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

UChicago and MWCN will recruit and enroll 20 health centers (HCs) to participate in a training intervention and to implement diabetes group visit and text messaging programs at their clinic sites. Each HC will assemble a team of 3-4 providers and staff to participate in the training. HCs will be randomized to one of two training cohorts. HC providers and staff will attend two in-person Learning Sessions in Chicago and a series of monthly webinars, recruit and enroll patients, implement a 6-month diabetes group visit and text messaging program plus subsequent booster sessions, complete periodic surveys and interviews, assist with data collection through patient surveys and chart abstraction, and present their program to peer HCs during Learning Sessions and to local stakeholders, state primary care organizations, or other professional groups. Each HC will enroll 15 patients in the group visit and text messaging program; the 2018 Training Cohort will do so immediately following their enrollment in the study and the 2020 Training Cohort will do so after 18 months. During the first 18 months, the 2020 Training Cohort will collect data from electronic health records (EHR) of randomly selected patients to serve as a control group. Changes in self-reported outcomes, diabetes processes of care, and clinical outcomes will be assessed for intervention patients from baseline through 2 year follow up, and processes of care and clinical outcomes will be compared for intervention vs. control participants. Capacity of HC providers and staff to conduct a group visit and text messaging intervention for patients with diabetes, as well as their confidence in identifying and addressing health disparities, will be evaluated through surveys and in-depth interviews. This study will expand knowledge of the barriers, facilitators, and perceived benefits and drawbacks of group visit and text messaging interventions and inform the development of a toolkit that will be disseminated to other HCs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • diagnosis of type 2 diabetes
  • attended at least two appointments at the HC within the past year, with at least one of them being during the past six months
  • last documented A1c result greater than or equal to 8.0% (test must have been done during the last 6 months)
  • own a cellular phone with text messaging capabilities
  • have the ability to read and send text messages
  • English or Spanish speaking

Exclusion criteria

  • pregnant or planning to become pregnant
  • uncontrolled psychiatric problem
  • dementia or other cognitive impairment
  • hearing difficulties or severe physical disability that would prevent them from participation in group visit
  • planning to relocate in the next year or leave the area during the group visit period

Treatment and study plan

Diabetes MESSAGES Program

Other

Health centers in the 2018 Training Cohort will enroll groups of 10-15 patients to attend 6 monthly diabetes group visits consisting of group education, social support, goal setting, and an individual medical visit for each patient. At the same time, patients will be enrolled in a 6-month interactive diabetes text messaging program. Patients will receive quarterly booster sessions for 1-2 years after the 6-month intervention period.

Diabetes MESSAGES Program (second trial)

Other

During the first trial period, health centers in the 2020 Training Cohort will collect data on patients receiving usual care. After the first trial period, health centers in the 2020 Training Cohort will enroll groups of 10-15 patients to attend 6 monthly diabetes group visits consisting of group education, social support, goal setting, and an individual medical visit for each patient. At the same time, patients will be enrolled in a 6-month interactive diabetes text messaging program. Patients will receive quarterly booster sessions for 1-2 years after the 6-month intervention period.

Primary outcomes

  1. Hemoglobin A1C

    Time frame: change from baseline to 12 months

Secondary outcomes

  1. Hemoglobin A1C

    Time frame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only

  2. Blood pressure

    Time frame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only

  3. Weight

    Time frame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only

  4. Cholesterol

    Time frame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only

  5. Diabetes processes of care

    Time frame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only

    Receipt of recommended screenings, exams, referrals, and vaccinations

  6. Medication management of diabetes

    Time frame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only

    changes in prescribed diabetes medications for patients with inadequate diabetes control

  7. Number of hypoglycemic events

    Time frame: baseline, 6 month, and 12 month for intervention patients only

  8. Number of hospital admissions

    Time frame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only

  9. Number of primary care, specialist, and ER visits

    Time frame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only

  10. Smoking status

    Time frame: baseline, 6 month, and 12 month for intervention patients only

  11. Health related quality of life (SF-12)

    Time frame: baseline, 6 month, and 12 month for intervention patients only

  12. Depression (PHQ-2)

    Time frame: baseline, 6 month, and 12 month for intervention patients only

  13. Summary of Diabetes Self-Care Activities Measure

    Time frame: baseline, 6 month, and 12 month for intervention patients only

  14. Understanding of Diabetes Self-Management (Diabetes Care Profile)

    Time frame: baseline, 6 month, and 12 month for intervention patients only

  15. Attitudes Towards Diabetes (Diabetes Care Profile)

    Time frame: baseline, 6 month, and 12 month for intervention patients only

  16. Diabetes Distress Scale (DDS-2)

    Time frame: baseline, 6 month, and 12 month for intervention patients only

  17. Diabetes Quality of Life Scale

    Time frame: baseline, 6 month, and 12 month for intervention patients only

  18. Diabetes Self-Empowerment Scale

    Time frame: baseline, 6 month, and 12 month for intervention patients only

  19. Diabetes Social Support Scale

    Time frame: baseline, 6 month, and 12 month for intervention patients only

  20. Patient satisfaction with intervention

    Time frame: 6 month and 12 month for intervention patients only

  21. CAHPS Overall Rating

    Time frame: baseline, 6 month, and 12 month for intervention patients only

    Patient satisfaction with overall care at health center

  22. CAHPS Cultural Competency

    Time frame: baseline, 6 month, and 12 month for intervention patients only

    Patient satisfaction with cultural competency of care at health center

  23. CAHPS Provider Communication

    Time frame: baseline, 6 month, and 12 month for intervention patients only

    Patient satisfaction with provider communication at health center

Other outcomes

  1. Patient engagement

    Time frame: through study completion, an average of 2 years

    Attendance/participation in group visits, text messaging, and booster sessions

  2. Health center provider/staff preparedness

    Time frame: change from pre- to post-training (from baseline to 1 month, 7 month, and 16 month)

    Capacity, confidence, motivation, perceived benefits and barriers

  3. Health center provider/staff satisfaction

    Time frame: post-training (16 month)

    Satisfaction with training, group visits, and text messaging

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • CareMessage
  • Midwest Clinicians' Network

Registry information

Official study title

Diabetes MESSAGES (Medical Care, Education, Social Support, And Goal-setting to Empower Self-management): Implementing Diabetes Group Visits and Text Messaging in Community Health Centers

Acronym: MESSAGES

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Apr 4, 2018
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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