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

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ClinicalTrials.gov Identifier: NCT03487692
Recruitment Status : Recruiting
First Posted : April 4, 2018
Last Update Posted : February 8, 2019
Sponsor:
Collaborators:
Midwest Clinicians' Network
CareMessage
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Other: Diabetes MESSAGES Program Other: Diabetes MESSAGES Program (second trial) Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official 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
Actual Study Start Date : October 18, 2018
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 2018 Training Cohort
10 health centers will be randomized to the 2018 Training Cohort. Teams from these health centers will be trained and will implement a 6 month diabetes group visit and text messaging intervention (Diabetes MESSAGES Program).
Other: Diabetes MESSAGES Program
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.

2020 Training Cohort
10 health centers will be randomized to the 2020 Training Cohort. Prior to beginning training, these health centers will collect data on randomly selected patients receiving usual care to serve as the control group. After this first parallel group trial period, teams from these health centers will be trained and will implement the 6 month diabetes group visit and text messaging intervention during a second single group trial period (Diabetes MESSAGES Program (second trial)).
Other: Diabetes MESSAGES Program (second trial)
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 Outcome Measures :
  1. Hemoglobin A1C [ Time Frame: change from baseline to 12 months ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • 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

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): NCT03487692


Contacts
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Contact: Erin Staab, MPH 7737023962 estaab@medicine.bsd.uchicago.edu
Contact: Arshiya Baig, MD, MPH 7738344760 abaig@medicine.bsd.uchicago.edu

Locations
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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Erin Staab, MPH    773-702-3962    estaab@medicine.bsd.uchicago.edu   
Sponsors and Collaborators
University of Chicago
Midwest Clinicians' Network
CareMessage
Investigators
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Principal Investigator: Arshiya Baig, MD, MPH University of Chicago

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03487692     History of Changes
Other Study ID Numbers: IRB17-1385
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Chicago:
diabetes
group visit
shared medical appointment
text messaging

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases