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

NCT03487692 | Completed

• 1 other identifier: IRB17-1385
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetes; group visit; shared medical appointment; text messaging

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1C

  change from baseline to 12 months

Secondary Outcomes (23)

• Hemoglobin A1C

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

• Blood pressure

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

• Weight

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

• Cholesterol

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

• Diabetes processes of care

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

Other Outcomes (3)

• Patient engagement

  through study completion, an average of 2 years

• Health center provider/staff preparedness

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

• Health center provider/staff satisfaction

  post-training (16 month)

Study Arms (2)

2018 Training Cohort

EXPERIMENTAL

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

2020 Training Cohort

OTHER

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)

Interventions

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.

2018 Training Cohort

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.

2020 Training Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead
• Midwest Clinicians' Network: collaborator
• CareMessage: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Arshiya Baig, MD, MPH

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: April 4, 2018
• Study Start: October 18, 2018
• Primary Completion: May 15, 2022
• Study Completion: June 30, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)